Biosimilars Legislation Discussion
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Transcript of Biosimilars Legislation Discussion
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Biosimilars 2007, George Washington University
Achieving A Middle Ground On
Balancing A Robust Scientific PathwayAnd Respect For IP Rights
(Promoting Continued BioPharma Innovation
While Advancing Access To Medicines)
JOHN M. ENGEL, ESQ.
MANAGING PARTNER
ENGEL & NOVITT, LLPTHE LAW FIRM THAT KNOWS ITS SCIENCE
1ENGEL & NOVITT, LLP The Law Firm That Knows its ScienceThe Law Firm That Knows its Science
September 24, 2007
Washington, DC
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OUTLINEOUTLINE
Biopharmaceuticals Play A Crucial Role In An Era Of SignificantBiopharmaceuticals Play A Crucial Role In An Era Of SignificantScientific And R&D AdvancesScientific And R&D Advances
Barriers To Entry For Biosimilars Will Be Overcome As The IndustryBarriers To Entry For Biosimilars Will Be Overcome As The Industry
Evolves And As Science AdvancesEvolves And As Science Advances Biosimilars Represent A Myriad Of Opportunities For The BreadthBiosimilars Represent A Myriad Of Opportunities For The Breadth
Of The BioPharma IndustryOf The BioPharma Industry
Robust Biosimilars PathwayRobust Biosimilars Pathway Balancing Intellectual Property Rights (IPRs) To Enable InnovationBalancing Intellectual Property Rights (IPRs) To Enable Innovation
And Access To MedicinesAnd Access To Medicines Legislative Options And OpportunitiesLegislative Options And Opportunities A Robust BiosimilarsA Robust Biosimilars
Pathway With Data Exclusivity And Decoupling Of PatentsPathway With Data Exclusivity And Decoupling Of Patents ConclusionsConclusions A Middle Ground On Biosimilars Legislation IsA Middle Ground On Biosimilars Legislation Is
The material and viewpoints set forth in this slide deckand conveyed during this presentation are presented by the author
2ENGEL & NOVITT, LLP The Law Firm That Knows its ScienceThe Law Firm That Knows its Science
in his capacity as Managing Partner of Engel & Novitt, LLP.They do not represent and do not purport to represent the views of the law firm
or any current or former-client of the firm, and should not be construed as such.
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Scientific Advances Continue AffectingScientific Advances Continue Affecting
Regulatory/ Marketplace R&D OutputsRegulatory/ Marketplace R&D Outputs Medical science is entering an exciting era of discoveryMedical science is entering an exciting era of discovery
and research advances barely imaginable 20 years agoand research advances barely imaginable 20 years ago
Biomarkers, genomics, molecular targeting,Biomarkers, genomics, molecular targeting,nanotechnology, personalized medicine, proteomics,nanotechnology, personalized medicine, proteomics,
threshold of a revolution of advanced biologythreshold of a revolution of advanced biology
The inherent risks associated with innovating on thisThe inherent risks associated with innovating on thiscu ng e ge ecome even grea er as ec no ogycu ng e ge ecome even grea er as ec no ogycontinues advancing and regulatory paradigms strive tocontinues advancing and regulatory paradigms strive tocatch up while maintaining the Precautionary Principlecatch up while maintaining the Precautionary Principle
More biopharmaceuticals fail later in developmentMore biopharmaceuticals fail later in development
Biopharmaceuticals making it through the pipelineBiopharmaceuticals making it through the pipeline
3ENGEL & NOVITT, LLP The Law Firm That Knows its ScienceThe Law Firm That Knows its Science
--
patient populations and precise subpatient populations and precise sub--populationspopulations
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BiotechBiotech MedicinesMedicines R&DR&D PortfolioPortfolio IsIs
GrowingGrow ing ApprovalsApprovals NotNot KeepingKeeping PacePace
418450
369 371
324350
400
US DataUS Data
250But Only 4But Only 4
BiotechBiotechBLAsBLAs
81
143150
ApprovedApprovedBy FDA InBy FDA In
CY06CY06
50
4ENGEL & NOVITT, LLP The Law Firm That Knows its ScienceThe Law Firm That Knows its Science
1988 1993 1996 2000 2002 2004 2006
Reference: PhRMA Drugs In Development
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BiopharmaceuticalsBiopharmaceuticals KeyKey AssetsAssets InIn
IndustryIndustry PortfoliosPortfolios AsAs ScienceScience AdvancesAdvances Within this evolving R&D and regulatoryWithin this evolving R&D and regulatory
environment, biopharmaceuticals are a criticalenvironment, biopharmaceuticals are a critical
component of the entire industrys portfoliocomponent of the entire industrys portfolio This applies to both traditional innovator andThis applies to both traditional innovator and
A vibrant biopharmaceuticals business is necessaryA vibrant biopharmaceuticals business is necessary
for growth and developmentfor growth and development
Ability to target biopharmaceuticals R&D opens upAbility to target biopharmaceuticals R&D opens upa range of opportunities in the marketplacea range of opportunities in the marketplace
owerower--cos n erc angea e s once eg ma ecos n erc angea e s once eg ma eIP expiresIP expires
--
5ENGEL & NOVITT, LLP The Law Firm That Knows its ScienceThe Law Firm That Knows its Science
PremiumPremium--priced secondpriced second--generation biologicsgeneration biologics
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ExistingExisting ArtificialArtificial BarriersBarriers ToTo EntryEntry ForForBiosimilarsBiosimilars CanCan BeBe OvercomeOvercome
Biosimilars are an option for the entire breadth of theBiosimilars are an option for the entire breadth of theBioPharma industry, as more targetBioPharma industry, as more target--products andproducts andsponsors emerge as more pa en s exp responsors emerge as more pa en s exp re
BiosimilarsBiosimilars are the greatest opportunity to the mostare the greatest opportunity to the mostcapable and innovative companies across industrycapable and innovative companies across industry
InnovatorsInnovatorshave extensive biologics experiencehave extensive biologics experience
and will be able to produce biosimilars, and can beand will be able to produce biosimilars, and can be,,pipeline and attendant excess capacitypipeline and attendant excess capacity
Emerging biotech companiesEmerging biotech companies will use biosimilars aswill use biosimilars as
development of their own innovative pipelinedevelopment of their own innovative pipeline
Generics and CMOsGenerics and CMOs have capacity andhave capacity and
6ENGEL & NOVITT, LLP The Law Firm That Knows its ScienceThe Law Firm That Knows its Science
experience, some extensively in biologics, andexperience, some extensively in biologics, and
their investment timeframes are often shortertheir investment timeframes are often shorter
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BiosimilarsBiosimilars PresentPresent NovelNovel LCMLCM AndAndDevelopmentDevelopment OpportunitiesOpportunities
As the biosimilars debate moves forward in theAs the biosimilars debate moves forward in theU.S. and globally and political trades areU.S. and globally and political trades are
negotiated, wellnegotiated, well--positioned and forwardpositioned and forward--thinkingthinkingBioPharmas have a unique opportunityBioPharmas have a unique opportunity
Meeting the innovation challenge necessitatesMeeting the innovation challenge necessitates
leveraging opportunities in lead marketsleveraging opportunities in lead markets the U.S.the U.S. w r rw r r
The traditional U.S. RoW developmentThe traditional U.S. RoW development--marketin aradi m needs rethinkinmarketin aradi m needs rethinkin
Truly innovative companies will meet challengeTruly innovative companies will meet challenge
7ENGEL & NOVITT, LLP The Law Firm That Knows its ScienceThe Law Firm That Knows its Science
benefit in patientsbenefit in patients ---- capitalizing on biosimilarscapitalizing on biosimilars
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BiosimilarsBiosimilars RegulatoryRegulatory ConsiderationsConsiderations
RecognizingRecognizing && SeizingSeizing OpportunitiesOpportunities Biologics generally are considered complexBiologics generally are considered complex and yetand yet
FDA and other HAs continue approving innovatorFDA and other HAs continue approving innovator
biologics, which, by definition, are the ones we knowbiologics, which, by definition, are the ones we knowthe least about at the time of approvalthe least about at the time of approval
Bio ogics an rugs are presume to e i erent, utBio ogics an rugs are presume to e i erent, utonly the U.S. has distinct regulatory pathways, andonly the U.S. has distinct regulatory pathways, andthe EU is settin biosimilar recedents safel the EU is settin biosimilar recedents safel
Patient safety is critically important, but so is accessPatient safety is critically important, but so is accessto lifeto life--saving medicinessaving medicines and cost mattersand cost matters
Approvals of biosimilars are presumed to be a lossApprovals of biosimilars are presumed to be a lossfor innovator manufacturers, but a revisiting of thefor innovator manufacturers, but a revisiting of the
8ENGEL & NOVITT, LLP The Law Firm That Knows its ScienceThe Law Firm That Knows its Science
regu a ory s an ar s or o og cs cou eneregu a ory s an ar s or o og cs cou ene
innovatorsas well as patientsinnovatorsas well as patients
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PHSPHS ActAct LicensingLicensing CriteriaCriteria ForFor AA
BiologicBiologic[[42 U.S.C.42 U.S.C. 262(a)(2)(A)262(a)(2)(A)]] Broad De legat i on Of Au t ho r i t y B road De legat i on Of Au t ho r i t y
The Secretary shall approve a biologics licenseThe Secretary shall approve a biologics license----
(i)(i) on the basis of a demonstration thaton the basis of a demonstration that----(I)(I) the biological product that is the subject of thethe biological product that is the subject of the
application is safe, pure, and potent; andapplication is safe, pure, and potent; and
(II)(II) the facility in which the biological product isthe facility in which the biological product ismanufactured, processed, packed, or held meetsmanufactured, processed, packed, or held meetsstandards designed to assure that the biologicalstandards designed to assure that the biologicalproduct continues to be safe, pure, and potent;product continues to be safe, pure, and potent;andand
(ii)(ii) if the applicant (or other appropriate person)if the applicant (or other appropriate person)consents to the inspection of the facility that is theconsents to the inspection of the facility that is thesub ect of the a lication, in accordance withsub ect of the a lication, in accordance with
9ENGEL & NOVITT, LLP The Law Firm That Knows its ScienceThe Law Firm That Knows its Science
subsection (c) of this section.subsection (c) of this section.
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ImplicationsImplications OfOf ExistingExisting RegulatoryRegulatoryFrameworkFramework ForFor BiologicsBiologics ApprovalsApprovals
The burden is always on the sponsor toThe burden is always on the sponsor todemonstrate safet urit otenc under the PHSdemonstrate safet urit otenc under the PHS
Act (or safety and efficacy under the FD&C Act)Act (or safety and efficacy under the FD&C Act) -- --
always confidential, and always dependent uponalways confidential, and always dependent upon
what is being requested by the sponsor for its labelwhat is being requested by the sponsor for its label
FDA can apply the same criteria to biosimilarsFDA can apply the same criteria to biosimilars
,,approve PHS Act biologics as interchangeableapprove PHS Act biologics as interchangeable nothing more, nothing lessnothing more, nothing less
10ENGEL & NOVITT, LLP The Law Firm That Knows its ScienceThe Law Firm That Knows its Science
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ConsistentConsistent RegulatoryRegulatory StandardsStandards CanCan BeBe
TheThe TouchstoneTouchstone OfOf BiologicsBiologics RegulationRegulation For the patient, what matters is that all biotechFor the patient, what matters is that all biotech
products are made to consistent and appropriatelyproducts are made to consistent and appropriately
high regulatory standardshigh regulatory standards Standards must rely on data that supports theStandards must rely on data that supports the
statutory requirements o sa ety, purity, an potencystatutory requirements o sa ety, purity, an potency
Unless industry works with regulators, and otherUnless industry works with regulators, and other
,,increase for no net benefit in safety, or efficacyincrease for no net benefit in safety, or efficacy especially in a postespecially in a post--Vioxx worldVioxx world
It is unnecessarily risky for innovators own portfoliosIt is unnecessarily risky for innovators own portfoliosto overplay safety fears on FOBs, as innovator BLAsto overplay safety fears on FOBs, as innovator BLAs
11ENGEL & NOVITT, LLP The Law Firm That Knows its ScienceThe Law Firm That Knows its Science
are stumbling as a result of those argumentsare stumbling as a result of those arguments
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RegulatoryRegulatory OpportunitiesOpportunities ExistsExists ForForTheThe EntireEntire BioPharmaBioPharma IndustryIndustry
Approval of FOBs are presumed to be a loss forApproval of FOBs are presumed to be a loss forinnovators, and IP incentives a loss for FOBs sponsorsinnovators, and IP incentives a loss for FOBs sponsors
Revisiting regu atory criteria or io ogics anRevisiting regu atory criteria or io ogics anincentivizing research to generate more robustincentivizing research to generate more robustpipelines benefits entire BioPharma industry andpipelines benefits entire BioPharma industry andpatientspatients
Innovators can appropriately justify reduction inInnovators can appropriately justify reduction in
of biologics functionof biologics function
Biosimilars sponsors can legitimately asked toBiosimilars sponsors can legitimately asked to
prov e more ata t an requ re or tra t onaprov e more ata t an requ re or tra t onageneric drugsgeneric drugs
12ENGEL & NOVITT, LLP The Law Firm That Knows its ScienceThe Law Firm That Knows its Science
in the US rather than seeing R&D outsourced abroadin the US rather than seeing R&D outsourced abroad
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BiosimilarsBiosimilars AreAre AnAn OpportunityOpportunity AndAnd
CanCan FacilitateFacilitate RegulatoryRegulatory ProgressProgress Biosimilars enable reevaluation of biologics regulationsBiosimilars enable reevaluation of biologics regulations
and can enhance the future regulatory frameworkand can enhance the future regulatory framework
Better regulations will stimulate upgraded facilities andBetter regulations will stimulate upgraded facilities andmore efficient biologics manufacturing (PAT, QbD, etc.)more efficient biologics manufacturing (PAT, QbD, etc.)
Competitive marketCompetitive market--based pricing could enablebased pricing could enableconsumers to become more accepting of higher brandconsumers to become more accepting of higher brand
The perception of indefinite monopolies resultingThe perception of indefinite monopolies resultingfrom the continued absence of athwa s forfrom the continued absence of athwa s for
interchangeable biosimilars erodes that acceptanceinterchangeable biosimilars erodes that acceptance
The biosimilars debate allows policymakers toThe biosimilars debate allows policymakers to
13ENGEL & NOVITT, LLP The Law Firm That Knows its ScienceThe Law Firm That Knows its Science
restructure the regulatory framework within whichrestructure the regulatory framework within which
BioPharma operates and incentivize its future R&DBioPharma operates and incentivize its future R&D
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TheThe RegulatoryRegulatory EnvironmentEnvironment NeedsNeeds ToToEvolveEvolve JustJust AsAs TheThe ScienceScience IsIs EvolvingEvolving
The EU adopted legislative changes in the FML/NML toThe EU adopted legislative changes in the FML/NML toenable biosimilars and is continuing to approve themenable biosimilars and is continuing to approve them
as s own ncreas ng ex y app y ng ex s ngas s own ncreas ng ex y app y ng ex s ng
authority and only lacks authority for interchangeabilityauthority and only lacks authority for interchangeability Reimbursement is increasingly important andReimbursement is increasingly important and
formularies may drive patient options, and may makeformularies may drive patient options, and may makeFDA assessments of interchangeability less importantFDA assessments of interchangeability less important
Im ortant trades make FOBs less than zeroIm ortant trades make FOBs less than zero--sumsum
Regulatory burden can be reduced so BioPharmaRegulatory burden can be reduced so BioPharmaindustry gets updated regulations and old redundantindustry gets updated regulations and old redundant
Innovation can be stimulated and rewarded acrossInnovation can be stimulated and rewarded acrossthe full breadth of the BioPharma industrythe full breadth of the BioPharma industry
14ENGEL & NOVITT, LLP The Law Firm That Knows its ScienceThe Law Firm That Knows its Science
Legitimate IP for biologics and patient access can beLegitimate IP for biologics and patient access can be
mutually assuredmutually assured
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IPRsIPRs FuelFuel TheThe EngineEngine ThatThat AcceleratesAcceleratesTheThe BiomedicalBiomedical ResearchResearch EnterpriseEnterprise
IPRs are a critical factor in all innovation, especially withinIPRs are a critical factor in all innovation, especially withinthe BioPharma industry, ensuring the private sector has thethe BioPharma industry, ensuring the private sector has the
needed to develop new medicines vital to patient healthneeded to develop new medicines vital to patient health IPRs represent the legal protection for inventions, includingIPRs represent the legal protection for inventions, including
The protection afforded by IPRs allows inventors time toThe protection afforded by IPRs allows inventors time to
recoup their R&D investments, thereby providing investorsrecoup their R&D investments, thereby providing investorsthe assurance they need to risk the capital required to fundthe assurance they need to risk the capital required to fundboth the medical discovery process and new R&D initiativesboth the medical discovery process and new R&D initiatives
, ,, ,prosperity in inventions has been [elemental to] the advanceprosperity in inventions has been [elemental to] the advance
our country has made in the arts and sciences. Nothing moreour country has made in the arts and sciences. Nothing morestimulates effort than securit in the results of effort.stimulates effort than securit in the results of effort.
15ENGEL & NOVITT, LLP The Law Firm That Knows its ScienceThe Law Firm That Knows its Science
President Benjamin Harrison, Opening AddressPresident Benjamin Harrison, Opening Address
U.S. Patent System Centennial Celebration (1891)U.S. Patent System Centennial Celebration (1891)
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NexusNexus BetweenBetween ScientificScientific InnovationInnovationAndAnd IntellectualIntellectual PropertyProperty RightsRights (IPRs)(IPRs)
BasicBasic andand advancedadvanced scientificscientific researchresearch havehave beenbeenlon standinlon standin driversdrivers ofof innovationsinnovations beneficialbeneficial toto societsociet .. TheThepastpast half half centurycentury hashas witnessedwitnessed aa myriadmyriad of of scientificscientificdiscoveriesdiscoveries appliedapplied inin medicine,medicine, informationinformation technology,technology,biotechnolobiotechnolo a riculturala ricultural roductionroduction nanotechnolonanotechnolo andand aahosthost ofof otherother areasareas.. MoreMore recently,recently, thethe processesprocesses ofof creatingcreatingoror acquiringacquiring andand usingusing scientificscientific discoveriesdiscoveries andand innovationsinnovations
atat variousvarious stagesstages ofof developmentdevelopment havehave expandedexpanded withwith thethechangingchanging landscapelandscape ofof intellectualintellectual propertyproperty protectionsprotections inin thetheUnitedUnited StatesStates.. ScholarsScholars havehave pointedpointed outout thatthat bothboth thetheinputsinputs andand outputsoutputs ofof scientificscientific researchresearch increasinglyincreasingly areare
beingbeing protectedprotected throughthrough mechanismsmechanisms includingincludingbutbut notnotlimitedlimited totopatentingpatenting..
16ENGEL & NOVITT, LLP The Law Firm That Knows its ScienceThe Law Firm That Knows its Science
.. ,, .. ,, .. ,,ExperiencesExperiences inin thethe UnitedUnited StatesStates ScientificScientific CommunityCommunity:: AA ReportReport byby thethe ProjectProject OnOn ScienceScience AndAndIntellectualIntellectual PropertyProperty InIn TheThe PublicPublic InterestInterest (AAAS,(AAAS, 20072007)) (footnotes(footnotes omitted)omitted)..
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IPRsIPRs AreAre EssentialEssential ToTo TheThe BreadthBreadth OfOfTheThe BioPharmaBioPharma IndustryIndustry
As R&D and regulatory risks increase as the technologyAs R&D and regulatory risks increase as the technologyadvances, BioPharmas can become as risk adverse towardsadvances, BioPharmas can become as risk adverse towards
productsproducts IPRs are an essential safety net to protect the substantialIPRs are an essential safety net to protect the substantial
biopharmaceutical to market and to mitigate the high risk ofbiopharmaceutical to market and to mitigate the high risk offailure inherent in biopharmaceutical R&Dfailure inherent in biopharmaceutical R&D
R&D spend on unproven technologies that ultimately areR&D spend on unproven technologies that ultimately areexpected to have much more limited commercializationexpected to have much more limited commercializationo ortunitieso ortunities
When the macroWhen the macro--level risks associated with BioPharma R&Dlevel risks associated with BioPharma R&Dare exacerbated by a safety debate or other public healthare exacerbated by a safety debate or other public healthcrisis the BioPharma industr s develo ment of medicinescrisis the BioPharma industr s develo ment of medicines
17ENGEL & NOVITT, LLP The Law Firm That Knows its ScienceThe Law Firm That Knows its Science
becomes dependent upon respect for and enforcement ofbecomes dependent upon respect for and enforcement of
legitimate IPRslegitimate IPRs
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BalancingBalancing IPRsIPRs ToTo EnableEnable InnovationInnovation AndAndPatientPatient AccessAccess ToTo MedicinesMedicines
In return for IPRs (in particular, patent rights), an inventordiscloses to the world the patented research and the science
This patent-publication process makes important scientificinformation underlying a new medicine available
,and encouraging the continuation of scientific discovery
In return for disclosing the invention to the public -r v ng sc ence orwar - an nven or rece ves e r g o
exclude others from practicing the invention for a limitedtime
Once patents expire, pathways should exist to allowrobust competition to commence in the marketplace
That com etition and resultin market forces su l
18ENGEL & NOVITT, LLP The Law Firm That Knows its ScienceThe Law Firm That Knows its Science
demand) can regulate pricing and incentivize
continued innovation
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BalancingBalancing IPRsIPRs ToTo EnableEnable InnovationInnovation AndAndPatientPatient AccessAccess ToTo MedicinesMedicines
Denying or overriding IPRs for innovative medicines does notbenefit patients or enhance patient access to treatments
patients continuous access to innovative new medicines (oreven generic products) Nonetheless as a matter of cor orate res onsibilit theNonetheless as a matter of cor orate res onsibilit the
BioPharma industry must be responsive to serious concerns ofBioPharma industry must be responsive to serious concerns ofrapidlyrapidly--rising costs for public health systems for countries inrising costs for public health systems for countries in
the developed world, and the lack of affordability of lifethe developed world, and the lack of affordability of life--savingsavingmedications in developing countriesmedications in developing countries
Market trends are favoring competing products (includingMarket trends are favoring competing products (includinggenerics and biosimilars), which are one part of the solutiongenerics and biosimilars), which are one part of the solution
ener cs os m ars e p eep expen ures own y prov ngener cs os m ars e p eep expen ures own y prov ngaffordable medicines, enabling healthcare systems to remain viableaffordable medicines, enabling healthcare systems to remain viable Utilization of generics/biosimilars also can free up capital for moreUtilization of generics/biosimilars also can free up capital for more
innovative treatmentsinnovative treatments
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IPRsIPRs && PostPost--ExpiryExpiry CompetitionCompetition CombineCombineToTo FacilitateFacilitate InnovationInnovation AndAnd AccessAccess
New InnovativeMedicines
InnovationInnovation
offersoffersimprovedimproved
Generics/
High-QualityGenerics/Biosimilars
treatmenttreatmentoptionsoptions
renderingrendering
free up
funds for
Generic/Biosimilar
generics/generics/biosimilarsbiosimilars
obsoleteobsolete
medicines
Obsolescence
In a priceIn a price--sensitive environment, with aging a primary global demographic trend associated withsensitive environment, with aging a primary global demographic trend associated with
20ENGEL & NOVITT, LLP The Law Firm That Knows its ScienceThe Law Firm That Knows its Science
the need for more medicines,the need for more medicines, generics/biosimilars contribute to public health in a fundamental waygenerics/biosimilars contribute to public health in a fundamental way Use of generics/biosimilars when patents expireUse of generics/biosimilars when patents expire frees up health care $s for innovative therapiesfrees up health care $s for innovative therapies
Generics/Biosimilars trigger further innovation byGenerics/Biosimilars trigger further innovation by stimulating revitalization of legacy portfoliosstimulating revitalization of legacy portfolios
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LegislativeLegislative OptionsOptions && OpportunitiesOpportunities AchievingAchieving BalanceBalance ForFor BiosimilarsBiosimilars
AA ViableViable Pathway Has Very Few Real RequirementsPathway Has Very Few Real Requirements DelegationDelegation of authority to FDA to licenseof authority to FDA to license
originally licensed under the PHS Actoriginally licensed under the PHS Act Authorities for FD&C Act FOBs already existAuthorities for FD&C Act FOBs already exist
r v v z ur v v z uinnovation in an increasinglyinnovation in an increasingly--risky R&D environmentrisky R&D environment
Continued decouplingContinued decoupling of the patent litigation and BLAof the patent litigation and BLArev ew process as ex s s o ay or o og csrev ew process as ex s s o ay or o og cs The case has not been made for linking patentThe case has not been made for linking patent
litigation to FDA review and approval of biologicslitigation to FDA review and approval of biologics
HatchHatch--Waxman is not really a viable model forWaxman is not really a viable model forbiosimilars beyond the core principle of balancebiosimilars beyond the core principle of balance
As it does toda decou lin ermits atentees toAs it does toda decou lin ermits atentees to
21ENGEL & NOVITT, LLP The Law Firm That Knows its ScienceThe Law Firm That Knows its Science
litigate to enforce patents whenever the patent lawslitigate to enforce patents whenever the patent laws
permit a case to be initiatedpermit a case to be initiated
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LegislativeLegislative OptionsOptions && OpportunitiesOpportunities ScienceScience--BasedBased RegulatoryRegulatory StandardsStandards
FollowFollow--on versions of biologic drugs approvedon versions of biologic drugs approvedunder the FD&C Act need no new authorities:under the FD&C Act need no new authorities:
ComparabilityComparability already appliesalready applies Interchangeability is based on therapeuticInterchangeability is based on therapeutic
equivalenceequivalence (pharmaceutical equivalence plus(pharmaceutical equivalence plusbioequivalence)bioequivalence)
Biosimilar versions of biolo ics licensed under theBiosimilar versions of biolo ics licensed under thePHS Act need authority for interchangeabilityPHS Act need authority for interchangeabilitydetermination following licensure based ondetermination following licensure based on
-- Standard established isStandard established is safety, purity, potencysafety, purity, potency ComparabilityComparability already appliesalready applies
22ENGEL & NOVITT, LLP The Law Firm That Knows its ScienceThe Law Firm That Knows its Science
at the structural, functional, and clinical levelsat the structural, functional, and clinical levels
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LegislativeLegislative OptionsOptions && OpportunitiesOpportunities RobustRobust PathwayPathway WithWith FDAFDA DeferenceDeference
Build on vast experience with biologicsBuild on vast experience with biologics statutorystatutoryenactments, regulatory implementation, andenactments, regulatory implementation, andadministrative precedents over the past 100 yearsadministrative precedents over the past 100 years and appropriately enable regulators and sponsorsand appropriately enable regulators and sponsors
Enable scientific experts at FDA to applyEnable scientific experts at FDA to apply consistentconsistent
andand predictablepredictable standards to all biologics to:standards to all biologics to: Encourage competitionEncourage competition
Stimulate innovationStimulate innovation through better use of priorthrough better use of prior
Build in opportunities/incentives forBuild in opportunities/incentives for secondsecond--eneration biolo icseneration biolo ics
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Facilitate globalFacilitate global harmonizationharmonization
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Legislative Options & OpportunitiesLegislative Options & Opportunities Granting Exclusivity & Respecting IPRsGranting Exclusivity & Respecting IPRs
Various forms ofVarious forms ofexclusivityexclusivity have been proposed, withhave been proposed, withthe EU model still meriting considerationthe EU model still meriting consideration
double that of the fourdouble that of the four--year period in the U.S. underyear period in the U.S. underthe NCE exclusivity provisions, and a preclusion onthe NCE exclusivity provisions, and a preclusion on. .. . --
NCE periodNCE period
Effectively combines data and market exclusivityEffectively combines data and market exclusivity ncen v zes con nue w po en a or +ncen v zes con nue w po en a or +
exclusivity period for significant new usesexclusivity period for significant new uses All types ofAll types ofpatentspatents should be appropriately respectedshould be appropriately respected
and enforced in every jurisdiction in which they applyand enforced in every jurisdiction in which they apply When patents expire, competition must be seen toWhen patents expire, competition must be seen to
beginbegin
24ENGEL & NOVITT, LLP The Law Firm That Knows its ScienceThe Law Firm That Knows its Science
In all cases,In all cases, trade secretstrade secrets must continue to bemust continue to be
respected by and for all sponsorsrespected by and for all sponsors
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LegislativeLegislative OptionsOptions && OpportunitiesOpportunities DecouplingDecoupling PatentsPatents AndAnd BLABLA LicensureLicensure
The biotechnology industry has grown andThe biotechnology industry has grown andprospered without any link between patents,prospered without any link between patents,patent litigation, and FDA licensure of productspatent litigation, and FDA licensure of products
Decoupling enables FDA to utilize its scientificDecoupling enables FDA to utilize its scientificexpertise and resources where it is mostexpertise and resources where it is mostappropriateappropriate on its public health mission ofon its public health mission of
Courts can continue to enforce biotech patentsCourts can continue to enforce biotech patents
-- -- Like cases before it,Like cases before it, Amgen v RocheAmgen v Roche pegylatedpegylated
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Court demonstrates viability of decouplingCourt demonstrates viability of decoupling
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NewNew Biosimilars Biosimilars PathwaysPathways AddressingAddressing EvergreeningEvergreening ClaimsClaims
Waxman, Schumer,Clinton included all
these pathways
ars)12
Full BLA URDE
N
VI
TY(
ye
subsection (a)
No regulatory
relief
SecondGeneration ?
e. .
H.E.L.P Legislationincludes these two
pathways AT
ORY
EXCLUSI
extrapolationbetweenindications
No reference toa rior roduct Interchangeable1
pegylation
REGUL
Biosimilar
Biosimilar
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Standards are Safety, Purity and Potency
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ExclusivityExclusivity && PathwayPathway DataData StandardsStandardsForFor SecondSecond--GenerationGeneration BiologicsBiologics
Pathways require the samedata as all are NMEs
(year
s)
12
Full BLASecond
Generation ? URDE
N
URDE
N
S
IVITY
subsection (a)
No regulatory
relief
e.g.pegylation
Full datarequirements AT
ORY
AT
ORY
H.E.L.P Legislationonly includes these
two pathways
EXCL
extrapolationbetweenindications
No reference toa rior roduct Interchangeable1
Noextrapolationbetweenindications
No reference to
REGUL
REGUL
BiosimilarBiosimilar
a prior product
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ExclusivityExclusivity && FlexibleFlexible DataData StandardsStandardsForFor SecondSecond--GenerationGeneration BiologicsBiologics
FOR SAME MOAIntermediate datarequirements?
(year
s)
12
Full BLA
ny ex rapo a on
between indications?Any reference to aprior product?
URDE
N
S
IVITY
subsection (a)
No regulatory
relief AT
ORY
EXCL
extrapolationbetweenindications
No reference toa rior roduct Interchangeable1
SecondGeneration ?
e.g. REGUL
Biosimilar
Biosimilar
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ExclusivityExclusivity AndAnd SecondSecond--GenerationGenerationBiologicsBiologics PathwayPathway OpportunitiesOpportunities
Can legislation include
ears)12
Full BLA
a ese ca egor es,based on MOA?
URDE
N
IV
ITY( subsection (a)
No regulatory
relief AT
ORY
EXCLU
extrapolationbetweenindications
No reference toa rior roduct Interchangeable1
SecondGeneration ?
e.g. REGUL
Biosimilar
Biosimilar
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C l iC l i AA MiddlMiddl G dG d OO
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ConclusionsConclusions AA MiddleMiddle GroundGround OnOnBiosimilarsBiosimilars LegislationLegislation IsIs AchievableAchievable
A constructive solution for the BioPharma industry, regulators,A constructive solution for the BioPharma industry, regulators,health care providers, and patients is readily achievablehealth care providers, and patients is readily achievable
Res ect for le itimate IPRs and ensuin marketRes ect for le itimate IPRs and ensuin market--basedbasedcompetition following patent expiry are both achievablecompetition following patent expiry are both achievable
An appropriate balance can drive continued innovation andAn appropriate balance can drive continued innovation andenable patient access to innovative and affordable medicinesenable patient access to innovative and affordable medicines
Competition from highCompetition from high--quality biosimilars should be encouragedquality biosimilars should be encouraged Neither side should fear a competitive marketplaceNeither side should fear a competitive marketplace
The global biotechnologyThe global biotechnology--based industry can afford tobased industry can afford torecogn ze s own success an e p es gn s u urerecogn ze s own success an e p es gn s u ure
Support consistent regulatory standards for all biologicsSupport consistent regulatory standards for all biologics Seize opportunity to use stateSeize opportunity to use state--ofof--the art technology tothe art technology to
Embrace global health authorities adoption ofEmbrace global health authorities adoption ofcomparability principles to limit trials and sizecomparability principles to limit trials and size
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evolving regulatory paradigms especially in RoWevolving regulatory paradigms especially in RoW
Develop improved and superior biologicsDevelop improved and superior biologics
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Thank You!
John M. Engel, Esq.Mana in Partner
ENGEL & NOVITT, LLPTHE LAW FIRM THAT KNOWS ITS SCIENCE
. .
202.207.3303
The material and viewpoints set forth in this slide deckand conveyed during this presentation are presented by the author
in his capacity as Managing Partner of Engel & Novitt, LLP.
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They do not represent and do not purport to represent the views of the law firmor any current or former-client of the firm, and should not be construed as such.