of biotech drugs

Libertad y OrdenABCWhat does the government seek with this regulation?

The Decree is issued for legal, technical and performance reasons of the health system. Reasons of a legal nature: The transitional paragraph of Article 89 of Law 1438 of 2011 ordered the health regulation of biologics. So did the Economic and Social Policy Council in its CONPES 155 of Pharmaceutical Policy of 2012 and CONPES 3697 of 2011 on the commercial development of biotechnology.

Reasons of technical nature: The current regulations governing health registration and surveillance were made especially for the evaluation of quality, effectiveness and safety of chemical synthesis drugs. However, applications for admission of new biological drugs, or those based on patents that are expiring, have increased significantly. For this reason it is important to update and adjust the drug registration regulation. Given the inevitable increase in competition due to patent expiration, it is important to have a regulation to protect public health by ensuring the quality of generic biological medicines that will enter the market, as well as for new drugs to be developed in the coming decades. With respect to competition, it is crucial for the quality requirements that are established to be highly stringent in order to protect the health of the citizens. It is also important that these quality requirements do not constitute unnecessary barriers to competition, since it is recognized that health regulation is a key element of the speed of competitive entry of drugs to the market.

Reasons associated with the operation and financial sustainability of the health system: There is a significant increase in Colombia in the cost of chronic noncommunicable diseases such as diabetes, cancer and high-cost illnesses for citizens and the health system. These diseases are increasingly treated with biologics. These drugs have become a very used alternative to prevent communicable diseases in children and vulnerable population. This is the case of recombinant vaccines against pneumococcus, rotavirus and human papillomavirus. Biotech drugs are the fastest-growing pharmaceutical market segment in Colombia, consistent with what is happening in the world. In 2013 about 30% of the total pharmaceutical market in Colombia (2 billion annual Colombian pesos) referred to products of biological origin. These drugs are mainly financed with public funds. Of the top 10 drugs recovered to the public health system, 8 are of biological origin. Most biotech drugs in the Colombian market are price controlled. However, this is a short-term measure, since the market readjusts quickly. It is therefore important to promote competition, which is the measure which produces the best effect in price reduction. In terms of competition, the prices of these drugs could decrease, on average, between 30% and 60%.

The Decree refers to three reporting paths. What are they?

There are three ways of presenting information to obtain entry clearance to market: A complete file path for the new biological drugs and two pathways for biogenerics: a path of comparability and a shortened path of comparability. The three paths require delivering a package of experiments and tests. These are essential

This document will provide answers to questions related to this subject, essentially important and of interest not only in Colombia but also throughout the world, due to the pioneering nature of the National Government’s proposition, embodied in the recently issued decree.

What are drugs of biological origin? They encompass a wide variety of medications. They are obtained from living organisms or their tissues. The sources and methods of manufacture include cell or microorganism cultures, or extraction from tissues or biological fluids such as blood.

What is the difference between biological medicinal products and biotech drugs? Biotech drugs are a special subset of drugs of biological origin. The biological medicinal products are produced by simple processes without the use of genetic information. Biotechs use genetic information and special technologies for cells to act as a substance manufacturer and then convert them into drugs.

What is the difference between drugs of chemical origin and biological origin?

Although the general production principles are similar, the characteristics of quality, safety and efficacy of drugs of biological origin depend on the source of the biological material, the complexity of the structure and the technological processes of obtaining it.

Why a special regulation for biologics?

Science and technology developments for production and the analytical characterization techniques advance rapidly and must be incorporated into the regulations on health registration and surveillance.

requirements, including immunogenicity testing, which are key for drug safety. The complete file path requires a complete package of pre-clinical and clinical testing, which involves large and complex experiments with healthy and ill animals and humans. The path of comparability is for drugs that are not new, but that are not yet sufficiently known and which have complex chemicals, which require comparative pre-clinical and clinical studies with the new drug. Given the uncertainty about the behavior of the active substance, it must be proven that it works in the body as does the new drug. The short path is for fully known drugs and with fully characterized chemicals, that is, that their physicochemical properties are known. By knowing the exact behavior of the active pharmaceutical ingredient, it is possible to conclude that it would work similarly to other drugs containing the same substance and therefore it would not be necessary either to repeat all the experiments with animals and humans, or to make them as complex and extensive.

What is the difference between a biotech drug and a biosimilar? Biosimilars are also biotech drugs. Usually there is a difference between, on the one hand, new, innovating, pioneering and brand biotech drugs, and on the other, biotech competitors, subsequent entry, biosimilars, biocomparables or biogenerics. The difference between the former and the latter is that new ones usually enter the market first and are patented because they represent technological innovations. Biogenerics can only enter the market once the patents of the new biotechs have expired because they are copies of them.

Are biogenerics or biosimilars safe for patients?

Certainly. Biogenerics can only be sold and then consumed after a rigorous review and approval process by the INVIMA.

What type of controls will the State establish to ensure the quality of biocompetidores or biosimilars?

A package of 9 types of tests will be required for all biotechs, ensuring the quality and safety of drugs entering the country.

What countries use biosimilar medicines?

All European countries, Brazil, Argentina, Mexico, Australia, Korea and others. Some are already on the market in Colombia.

Can everyone use biosimilars or biotechs?

Yes, according to the recommendations of the treating physician.

Are biotech drugs covered in the health system?

Yes. Given that they are costly medicines for the treatment of complex diseases, these drugs are covered by public health system resources via POS (Compulsory Health Plan) or via recoveries through Fosyga.

Will biosimilar medicines be covered by the health system?

Of course. Since bio competitors are an alternative for the treatment of diseases that are being treated with patented biotechs and which are paid with public funds in the health system, biogenerics will also be paid with those resources (via POS or via the Fosyga recoveries), but generating savings for the system.

When will the biosimilar medicines be able to enter the country?

Some bio competitors have already been approved in Colombia.

Will the entry of biosimilars impact users’ pockets? Biotech drugs are paid for by the health system, so the savings will be reflected in the system. However the resources saved will be used to invest in building hospitals, or include more drugs and technologies in health in the Mandatory Health Plan, to benefit all Colombians.

Will this impact the finances of the health system?

Each new competitor entering the market may reduce the price of the drug by 30% or 40%. If we had at least two competitors for each of the 8 most recovered drugs, the system would save about $ 600 billion pesos. With the savings, the Ministry can cover more treatments or extend the Mandatory Health Plan.

When does this Decree begin to operate?

The decree will come into operation only after the Ministry issues two important guides

(immunogenicity and stability). The decree grants the Ministry a year to issue them.

What does the government seek with this regulation?

The Decree is issued for legal, technical and performance reasons of the health system. Reasons of a legal nature: The transitional paragraph of Article 89 of Law 1438 of 2011 ordered the health regulation of biologics. So did the Economic and Social Policy Council in its CONPES 155 of Pharmaceutical Policy of 2012 and CONPES 3697 of 2011 on the commercial development of biotechnology.

Reasons of technical nature: The current regulations governing health registration and surveillance were made especially for the evaluation of quality, effectiveness and safety of chemical synthesis drugs. However, applications for admission of new biological drugs, or those based on patents that are expiring, have increased significantly. For this reason it is important to update and adjust the drug registration regulation. Given the inevitable increase in competition due to patent expiration, it is important to have a regulation to protect public health by ensuring the quality of generic biological medicines that will enter the market, as well as for new drugs to be developed in the coming decades. With respect to competition, it is crucial for the quality requirements that are established to be highly stringent in order to protect the health of the citizens. It is also important that these quality requirements do not constitute unnecessary barriers to competition, since it is recognized that health regulation is a key element of the speed of competitive entry of drugs to the market.

Reasons associated with the operation and financial sustainability of the health system: There is a significant increase in Colombia in the cost of chronic noncommunicable diseases such as diabetes, cancer and high-cost illnesses for citizens and the health system. These diseases are increasingly treated with biologics. These drugs have become a very used alternative to prevent communicable diseases in children and vulnerable population. This is the case of recombinant vaccines against pneumococcus, rotavirus and human papillomavirus. Biotech drugs are the fastest-growing pharmaceutical market segment in Colombia, consistent with what is happening in the world. In 2013 about 30% of the total pharmaceutical market in Colombia (2 billion annual Colombian pesos) referred to products of biological origin. These drugs are mainly financed with public funds. Of the top 10 drugs recovered to the public health system, 8 are of biological origin. Most biotech drugs in the Colombian market are price controlled. However, this is a short-term measure, since the market readjusts quickly. It is therefore important to promote competition, which is the measure which produces the best effect in price reduction. In terms of competition, the prices of these drugs could decrease, on average, between 30% and 60%.

The Decree refers to three reporting paths. What are they?

There are three ways of presenting information to obtain entry clearance to market: A complete file path for the new biological drugs and two pathways for biogenerics: a path of comparability and a shortened path of comparability. The three paths require delivering a package of experiments and tests. These are essential

This document will provide answers to questions related to this subject, essentially important and of interest not only in Colombia but also throughout the world, due to the pioneering nature of the National Government’s proposition, embodied in the recently issued decree.

What are drugs of biological origin? They encompass a wide variety of medications. They are obtained from living organisms or their tissues. The sources and methods of manufacture include cell or microorganism cultures, or extraction from tissues or biological fluids such as blood.

What is the difference between biological medicinal products and biotech drugs? Biotech drugs are a special subset of drugs of biological origin. The biological medicinal products are produced by simple processes without the use of genetic information. Biotechs use genetic information and special technologies for cells to act as a substance manufacturer and then convert them into drugs.

What is the difference between drugs of chemical origin and biological origin?

Although the general production principles are similar, the characteristics of quality, safety and efficacy of drugs of biological origin depend on the source of the biological material, the complexity of the structure and the technological processes of obtaining it.

Why a special regulation for biologics?

Science and technology developments for production and the analytical characterization techniques advance rapidly and must be incorporated into the regulations on health registration and surveillance.

requirements, including immunogenicity testing, which are key for drug safety. The complete file path requires a complete package of pre-clinical and clinical testing, which involves large and complex experiments with healthy and ill animals and humans. The path of comparability is for drugs that are not new, but that are not yet sufficiently known and which have complex chemicals, which require comparative pre-clinical and clinical studies with the new drug. Given the uncertainty about the behavior of the active substance, it must be proven that it works in the body as does the new drug. The short path is for fully known drugs and with fully characterized chemicals, that is, that their physicochemical properties are known. By knowing the exact behavior of the active pharmaceutical ingredient, it is possible to conclude that it would work similarly to other drugs containing the same substance and therefore it would not be necessary either to repeat all the experiments with animals and humans, or to make them as complex and extensive.

What is the difference between a biotech drug and a biosimilar? Biosimilars are also biotech drugs. Usually there is a difference between, on the one hand, new, innovating, pioneering and brand biotech drugs, and on the other, biotech competitors, subsequent entry, biosimilars, biocomparables or biogenerics. The difference between the former and the latter is that new ones usually enter the market first and are patented because they represent technological innovations. Biogenerics can only enter the market once the patents of the new biotechs have expired because they are copies of them.

Are biogenerics or biosimilars safe for patients?

Certainly. Biogenerics can only be sold and then consumed after a rigorous review and approval process by the INVIMA.

What type of controls will the State establish to ensure the quality of biocompetidores or biosimilars?

A package of 9 types of tests will be required for all biotechs, ensuring the quality and safety of drugs entering the country.

What countries use biosimilar medicines?

All European countries, Brazil, Argentina, Mexico, Australia, Korea and others. Some are already on the market in Colombia.

Can everyone use biosimilars or biotechs?

Yes, according to the recommendations of the treating physician.

Are biotech drugs covered in the health system?

Yes. Given that they are costly medicines for the treatment of complex diseases, these drugs are covered by public health system resources via POS (Compulsory Health Plan) or via recoveries through Fosyga.

Will biosimilar medicines be covered by the health system?

Of course. Since bio competitors are an alternative for the treatment of diseases that are being treated with patented biotechs and which are paid with public funds in the health system, biogenerics will also be paid with those resources (via POS or via the Fosyga recoveries), but generating savings for the system.

When will the biosimilar medicines be able to enter the country?

Some bio competitors have already been approved in Colombia.

Will the entry of biosimilars impact users’ pockets? Biotech drugs are paid for by the health system, so the savings will be reflected in the system. However the resources saved will be used to invest in building hospitals, or include more drugs and technologies in health in the Mandatory Health Plan, to benefit all Colombians.

Will this impact the finances of the health system?

Each new competitor entering the market may reduce the price of the drug by 30% or 40%. If we had at least two competitors for each of the 8 most recovered drugs, the system would save about $ 600 billion pesos. With the savings, the Ministry can cover more treatments or extend the Mandatory Health Plan.

When does this Decree begin to operate?

The decree will come into operation only after the Ministry issues two important guides

(immunogenicity and stability). The decree grants the Ministry a year to issue them.

What does the government seek with this regulation?

The Decree is issued for legal, technical and performance reasons of the health system. Reasons of a legal nature: The transitional paragraph of Article 89 of Law 1438 of 2011 ordered the health regulation of biologics. So did the Economic and Social Policy Council in its CONPES 155 of Pharmaceutical Policy of 2012 and CONPES 3697 of 2011 on the commercial development of biotechnology.

Reasons of technical nature: The current regulations governing health registration and surveillance were made especially for the evaluation of quality, effectiveness and safety of chemical synthesis drugs. However, applications for admission of new biological drugs, or those based on patents that are expiring, have increased significantly. For this reason it is important to update and adjust the drug registration regulation. Given the inevitable increase in competition due to patent expiration, it is important to have a regulation to protect public health by ensuring the quality of generic biological medicines that will enter the market, as well as for new drugs to be developed in the coming decades. With respect to competition, it is crucial for the quality requirements that are established to be highly stringent in order to protect the health of the citizens. It is also important that these quality requirements do not constitute unnecessary barriers to competition, since it is recognized that health regulation is a key element of the speed of competitive entry of drugs to the market.

Reasons associated with the operation and financial sustainability of the health system: There is a significant increase in Colombia in the cost of chronic noncommunicable diseases such as diabetes, cancer and high-cost illnesses for citizens and the health system. These diseases are increasingly treated with biologics. These drugs have become a very used alternative to prevent communicable diseases in children and vulnerable population. This is the case of recombinant vaccines against pneumococcus, rotavirus and human papillomavirus. Biotech drugs are the fastest-growing pharmaceutical market segment in Colombia, consistent with what is happening in the world. In 2013 about 30% of the total pharmaceutical market in Colombia (2 billion annual Colombian pesos) referred to products of biological origin. These drugs are mainly financed with public funds. Of the top 10 drugs recovered to the public health system, 8 are of biological origin. Most biotech drugs in the Colombian market are price controlled. However, this is a short-term measure, since the market readjusts quickly. It is therefore important to promote competition, which is the measure which produces the best effect in price reduction. In terms of competition, the prices of these drugs could decrease, on average, between 30% and 60%.

The Decree refers to three reporting paths. What are they?

There are three ways of presenting information to obtain entry clearance to market: A complete file path for the new biological drugs and two pathways for biogenerics: a path of comparability and a shortened path of comparability. The three paths require delivering a package of experiments and tests. These are essential

This document will provide answers to questions related to this subject, essentially important and of interest not only in Colombia but also throughout the world, due to the pioneering nature of the National Government’s proposition, embodied in the recently issued decree.

What are drugs of biological origin? They encompass a wide variety of medications. They are obtained from living organisms or their tissues. The sources and methods of manufacture include cell or microorganism cultures, or extraction from tissues or biological fluids such as blood.

What is the difference between biological medicinal products and biotech drugs? Biotech drugs are a special subset of drugs of biological origin. The biological medicinal products are produced by simple processes without the use of genetic information. Biotechs use genetic information and special technologies for cells to act as a substance manufacturer and then convert them into drugs.

What is the difference between drugs of chemical origin and biological origin?

Although the general production principles are similar, the characteristics of quality, safety and efficacy of drugs of biological origin depend on the source of the biological material, the complexity of the structure and the technological processes of obtaining it.

Why a special regulation for biologics?

Science and technology developments for production and the analytical characterization techniques advance rapidly and must be incorporated into the regulations on health registration and surveillance.

requirements, including immunogenicity testing, which are key for drug safety. The complete file path requires a complete package of pre-clinical and clinical testing, which involves large and complex experiments with healthy and ill animals and humans. The path of comparability is for drugs that are not new, but that are not yet sufficiently known and which have complex chemicals, which require comparative pre-clinical and clinical studies with the new drug. Given the uncertainty about the behavior of the active substance, it must be proven that it works in the body as does the new drug. The short path is for fully known drugs and with fully characterized chemicals, that is, that their physicochemical properties are known. By knowing the exact behavior of the active pharmaceutical ingredient, it is possible to conclude that it would work similarly to other drugs containing the same substance and therefore it would not be necessary either to repeat all the experiments with animals and humans, or to make them as complex and extensive.

What is the difference between a biotech drug and a biosimilar? Biosimilars are also biotech drugs. Usually there is a difference between, on the one hand, new, innovating, pioneering and brand biotech drugs, and on the other, biotech competitors, subsequent entry, biosimilars, biocomparables or biogenerics. The difference between the former and the latter is that new ones usually enter the market first and are patented because they represent technological innovations. Biogenerics can only enter the market once the patents of the new biotechs have expired because they are copies of them.

Are biogenerics or biosimilars safe for patients?

Certainly. Biogenerics can only be sold and then consumed after a rigorous review and approval process by the INVIMA.

What type of controls will the State establish to ensure the quality of biocompetidores or biosimilars?

A package of 9 types of tests will be required for all biotechs, ensuring the quality and safety of drugs entering the country.

What countries use biosimilar medicines?

All European countries, Brazil, Argentina, Mexico, Australia, Korea and others. Some are already on the market in Colombia.

Can everyone use biosimilars or biotechs?

Yes, according to the recommendations of the treating physician.

Are biotech drugs covered in the health system?

Yes. Given that they are costly medicines for the treatment of complex diseases, these drugs are covered by public health system resources via POS (Compulsory Health Plan) or via recoveries through Fosyga.

Will biosimilar medicines be covered by the health system?

Of course. Since bio competitors are an alternative for the treatment of diseases that are being treated with patented biotechs and which are paid with public funds in the health system, biogenerics will also be paid with those resources (via POS or via the Fosyga recoveries), but generating savings for the system.

When will the biosimilar medicines be able to enter the country?

Some bio competitors have already been approved in Colombia.

Will the entry of biosimilars impact users’ pockets? Biotech drugs are paid for by the health system, so the savings will be reflected in the system. However the resources saved will be used to invest in building hospitals, or include more drugs and technologies in health in the Mandatory Health Plan, to benefit all Colombians.

Will this impact the finances of the health system?

Each new competitor entering the market may reduce the price of the drug by 30% or 40%. If we had at least two competitors for each of the 8 most recovered drugs, the system would save about $ 600 billion pesos. With the savings, the Ministry can cover more treatments or extend the Mandatory Health Plan.

When does this Decree begin to operate?

The decree will come into operation only after the Ministry issues two important guides

(immunogenicity and stability). The decree grants the Ministry a year to issue them.

What does the government seek with this regulation?

The Decree is issued for legal, technical and performance reasons of the health system. Reasons of a legal nature: The transitional paragraph of Article 89 of Law 1438 of 2011 ordered the health regulation of biologics. So did the Economic and Social Policy Council in its CONPES 155 of Pharmaceutical Policy of 2012 and CONPES 3697 of 2011 on the commercial development of biotechnology.

Reasons of technical nature: The current regulations governing health registration and surveillance were made especially for the evaluation of quality, effectiveness and safety of chemical synthesis drugs. However, applications for admission of new biological drugs, or those based on patents that are expiring, have increased significantly. For this reason it is important to update and adjust the drug registration regulation. Given the inevitable increase in competition due to patent expiration, it is important to have a regulation to protect public health by ensuring the quality of generic biological medicines that will enter the market, as well as for new drugs to be developed in the coming decades. With respect to competition, it is crucial for the quality requirements that are established to be highly stringent in order to protect the health of the citizens. It is also important that these quality requirements do not constitute unnecessary barriers to competition, since it is recognized that health regulation is a key element of the speed of competitive entry of drugs to the market.

Reasons associated with the operation and financial sustainability of the health system: There is a significant increase in Colombia in the cost of chronic noncommunicable diseases such as diabetes, cancer and high-cost illnesses for citizens and the health system. These diseases are increasingly treated with biologics. These drugs have become a very used alternative to prevent communicable diseases in children and vulnerable population. This is the case of recombinant vaccines against pneumococcus, rotavirus and human papillomavirus. Biotech drugs are the fastest-growing pharmaceutical market segment in Colombia, consistent with what is happening in the world. In 2013 about 30% of the total pharmaceutical market in Colombia (2 billion annual Colombian pesos) referred to products of biological origin. These drugs are mainly financed with public funds. Of the top 10 drugs recovered to the public health system, 8 are of biological origin. Most biotech drugs in the Colombian market are price controlled. However, this is a short-term measure, since the market readjusts quickly. It is therefore important to promote competition, which is the measure which produces the best effect in price reduction. In terms of competition, the prices of these drugs could decrease, on average, between 30% and 60%.

The Decree refers to three reporting paths. What are they?

There are three ways of presenting information to obtain entry clearance to market: A complete file path for the new biological drugs and two pathways for biogenerics: a path of comparability and a shortened path of comparability. The three paths require delivering a package of experiments and tests. These are essential

This document will provide answers to questions related to this subject, essentially important and of interest not only in Colombia but also throughout the world, due to the pioneering nature of the National Government’s proposition, embodied in the recently issued decree.

What are drugs of biological origin? They encompass a wide variety of medications. They are obtained from living organisms or their tissues. The sources and methods of manufacture include cell or microorganism cultures, or extraction from tissues or biological fluids such as blood.

What is the difference between biological medicinal products and biotech drugs? Biotech drugs are a special subset of drugs of biological origin. The biological medicinal products are produced by simple processes without the use of genetic information. Biotechs use genetic information and special technologies for cells to act as a substance manufacturer and then convert them into drugs.

What is the difference between drugs of chemical origin and biological origin?

Although the general production principles are similar, the characteristics of quality, safety and efficacy of drugs of biological origin depend on the source of the biological material, the complexity of the structure and the technological processes of obtaining it.

Why a special regulation for biologics?

Science and technology developments for production and the analytical characterization techniques advance rapidly and must be incorporated into the regulations on health registration and surveillance.

requirements, including immunogenicity testing, which are key for drug safety. The complete file path requires a complete package of pre-clinical and clinical testing, which involves large and complex experiments with healthy and ill animals and humans. The path of comparability is for drugs that are not new, but that are not yet sufficiently known and which have complex chemicals, which require comparative pre-clinical and clinical studies with the new drug. Given the uncertainty about the behavior of the active substance, it must be proven that it works in the body as does the new drug. The short path is for fully known drugs and with fully characterized chemicals, that is, that their physicochemical properties are known. By knowing the exact behavior of the active pharmaceutical ingredient, it is possible to conclude that it would work similarly to other drugs containing the same substance and therefore it would not be necessary either to repeat all the experiments with animals and humans, or to make them as complex and extensive.

What is the difference between a biotech drug and a biosimilar? Biosimilars are also biotech drugs. Usually there is a difference between, on the one hand, new, innovating, pioneering and brand biotech drugs, and on the other, biotech competitors, subsequent entry, biosimilars, biocomparables or biogenerics. The difference between the former and the latter is that new ones usually enter the market first and are patented because they represent technological innovations. Biogenerics can only enter the market once the patents of the new biotechs have expired because they are copies of them.

Are biogenerics or biosimilars safe for patients?

Certainly. Biogenerics can only be sold and then consumed after a rigorous review and approval process by the INVIMA.

What type of controls will the State establish to ensure the quality of biocompetidores or biosimilars?

A package of 9 types of tests will be required for all biotechs, ensuring the quality and safety of drugs entering the country.

What countries use biosimilar medicines?

All European countries, Brazil, Argentina, Mexico, Australia, Korea and others. Some are already on the market in Colombia.

Can everyone use biosimilars or biotechs?

Yes, according to the recommendations of the treating physician.

Are biotech drugs covered in the health system?

Yes. Given that they are costly medicines for the treatment of complex diseases, these drugs are covered by public health system resources via POS (Compulsory Health Plan) or via recoveries through Fosyga.

Will biosimilar medicines be covered by the health system?

Of course. Since bio competitors are an alternative for the treatment of diseases that are being treated with patented biotechs and which are paid with public funds in the health system, biogenerics will also be paid with those resources (via POS or via the Fosyga recoveries), but generating savings for the system.

When will the biosimilar medicines be able to enter the country?

Some bio competitors have already been approved in Colombia.

Will the entry of biosimilars impact users’ pockets? Biotech drugs are paid for by the health system, so the savings will be reflected in the system. However the resources saved will be used to invest in building hospitals, or include more drugs and technologies in health in the Mandatory Health Plan, to benefit all Colombians.

Will this impact the finances of the health system?

Each new competitor entering the market may reduce the price of the drug by 30% or 40%. If we had at least two competitors for each of the 8 most recovered drugs, the system would save about $ 600 billion pesos. With the savings, the Ministry can cover more treatments or extend the Mandatory Health Plan.

When does this Decree begin to operate?

The decree will come into operation only after the Ministry issues two important guides

(immunogenicity and stability). The decree grants the Ministry a year to issue them.

What does the government seek with this regulation?

The Decree is issued for legal, technical and performance reasons of the health system. Reasons of a legal nature: The transitional paragraph of Article 89 of Law 1438 of 2011 ordered the health regulation of biologics. So did the Economic and Social Policy Council in its CONPES 155 of Pharmaceutical Policy of 2012 and CONPES 3697 of 2011 on the commercial development of biotechnology.

Reasons of technical nature: The current regulations governing health registration and surveillance were made especially for the evaluation of quality, effectiveness and safety of chemical synthesis drugs. However, applications for admission of new biological drugs, or those based on patents that are expiring, have increased significantly. For this reason it is important to update and adjust the drug registration regulation. Given the inevitable increase in competition due to patent expiration, it is important to have a regulation to protect public health by ensuring the quality of generic biological medicines that will enter the market, as well as for new drugs to be developed in the coming decades. With respect to competition, it is crucial for the quality requirements that are established to be highly stringent in order to protect the health of the citizens. It is also important that these quality requirements do not constitute unnecessary barriers to competition, since it is recognized that health regulation is a key element of the speed of competitive entry of drugs to the market.

Reasons associated with the operation and financial sustainability of the health system: There is a significant increase in Colombia in the cost of chronic noncommunicable diseases such as diabetes, cancer and high-cost illnesses for citizens and the health system. These diseases are increasingly treated with biologics. These drugs have become a very used alternative to prevent communicable diseases in children and vulnerable population. This is the case of recombinant vaccines against pneumococcus, rotavirus and human papillomavirus. Biotech drugs are the fastest-growing pharmaceutical market segment in Colombia, consistent with what is happening in the world. In 2013 about 30% of the total pharmaceutical market in Colombia (2 billion annual Colombian pesos) referred to products of biological origin. These drugs are mainly financed with public funds. Of the top 10 drugs recovered to the public health system, 8 are of biological origin. Most biotech drugs in the Colombian market are price controlled. However, this is a short-term measure, since the market readjusts quickly. It is therefore important to promote competition, which is the measure which produces the best effect in price reduction. In terms of competition, the prices of these drugs could decrease, on average, between 30% and 60%.

The Decree refers to three reporting paths. What are they?

There are three ways of presenting information to obtain entry clearance to market: A complete file path for the new biological drugs and two pathways for biogenerics: a path of comparability and a shortened path of comparability. The three paths require delivering a package of experiments and tests. These are essential

This document will provide answers to questions related to this subject, essentially important and of interest not only in Colombia but also throughout the world, due to the pioneering nature of the National Government’s proposition, embodied in the recently issued decree.

What are drugs of biological origin? They encompass a wide variety of medications. They are obtained from living organisms or their tissues. The sources and methods of manufacture include cell or microorganism cultures, or extraction from tissues or biological fluids such as blood.

What is the difference between biological medicinal products and biotech drugs? Biotech drugs are a special subset of drugs of biological origin. The biological medicinal products are produced by simple processes without the use of genetic information. Biotechs use genetic information and special technologies for cells to act as a substance manufacturer and then convert them into drugs.

What is the difference between drugs of chemical origin and biological origin?

Although the general production principles are similar, the characteristics of quality, safety and efficacy of drugs of biological origin depend on the source of the biological material, the complexity of the structure and the technological processes of obtaining it.

Why a special regulation for biologics?

Science and technology developments for production and the analytical characterization techniques advance rapidly and must be incorporated into the regulations on health registration and surveillance.

requirements, including immunogenicity testing, which are key for drug safety. The complete file path requires a complete package of pre-clinical and clinical testing, which involves large and complex experiments with healthy and ill animals and humans. The path of comparability is for drugs that are not new, but that are not yet sufficiently known and which have complex chemicals, which require comparative pre-clinical and clinical studies with the new drug. Given the uncertainty about the behavior of the active substance, it must be proven that it works in the body as does the new drug. The short path is for fully known drugs and with fully characterized chemicals, that is, that their physicochemical properties are known. By knowing the exact behavior of the active pharmaceutical ingredient, it is possible to conclude that it would work similarly to other drugs containing the same substance and therefore it would not be necessary either to repeat all the experiments with animals and humans, or to make them as complex and extensive.

What is the difference between a biotech drug and a biosimilar? Biosimilars are also biotech drugs. Usually there is a difference between, on the one hand, new, innovating, pioneering and brand biotech drugs, and on the other, biotech competitors, subsequent entry, biosimilars, biocomparables or biogenerics. The difference between the former and the latter is that new ones usually enter the market first and are patented because they represent technological innovations. Biogenerics can only enter the market once the patents of the new biotechs have expired because they are copies of them.

Are biogenerics or biosimilars safe for patients?

Certainly. Biogenerics can only be sold and then consumed after a rigorous review and approval process by the INVIMA.

What type of controls will the State establish to ensure the quality of biocompetidores or biosimilars?

A package of 9 types of tests will be required for all biotechs, ensuring the quality and safety of drugs entering the country.

What countries use biosimilar medicines?

All European countries, Brazil, Argentina, Mexico, Australia, Korea and others. Some are already on the market in Colombia.

Can everyone use biosimilars or biotechs?

Yes, according to the recommendations of the treating physician.

Are biotech drugs covered in the health system?

Yes. Given that they are costly medicines for the treatment of complex diseases, these drugs are covered by public health system resources via POS (Compulsory Health Plan) or via recoveries through Fosyga.

Will biosimilar medicines be covered by the health system?

Of course. Since bio competitors are an alternative for the treatment of diseases that are being treated with patented biotechs and which are paid with public funds in the health system, biogenerics will also be paid with those resources (via POS or via the Fosyga recoveries), but generating savings for the system.

When will the biosimilar medicines be able to enter the country?

Some bio competitors have already been approved in Colombia.

Will the entry of biosimilars impact users’ pockets? Biotech drugs are paid for by the health system, so the savings will be reflected in the system. However the resources saved will be used to invest in building hospitals, or include more drugs and technologies in health in the Mandatory Health Plan, to benefit all Colombians.

Will this impact the finances of the health system?

Each new competitor entering the market may reduce the price of the drug by 30% or 40%. If we had at least two competitors for each of the 8 most recovered drugs, the system would save about $ 600 billion pesos. With the savings, the Ministry can cover more treatments or extend the Mandatory Health Plan.

When does this Decree begin to operate?

The decree will come into operation only after the Ministry issues two important guides

Libertad y Orden

Prepared by: Drugs and Technologies Division

Date: September 2014

(immunogenicity and stability). The decree grants the Ministry a year to issue them.