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Biosimilars are effective and safe and should immediately replace innovator molecules in the NHS Dr...
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Transcript of Biosimilars are effective and safe and should immediately replace innovator molecules in the NHS Dr...
![Page 1: Biosimilars are effective and safe and should immediately replace innovator molecules in the NHS Dr Chris Deighton Consultant Rheumatologist.](https://reader036.fdocuments.in/reader036/viewer/2022082600/5a4d1b237f8b9ab059995ff8/html5/thumbnails/1.jpg)
Biosimilars are effective and safe and should immediately replace innovator molecules in the
NHS
Dr Chris DeightonConsultant Rheumatologist
![Page 2: Biosimilars are effective and safe and should immediately replace innovator molecules in the NHS Dr Chris Deighton Consultant Rheumatologist.](https://reader036.fdocuments.in/reader036/viewer/2022082600/5a4d1b237f8b9ab059995ff8/html5/thumbnails/2.jpg)
![Page 3: Biosimilars are effective and safe and should immediately replace innovator molecules in the NHS Dr Chris Deighton Consultant Rheumatologist.](https://reader036.fdocuments.in/reader036/viewer/2022082600/5a4d1b237f8b9ab059995ff8/html5/thumbnails/3.jpg)
Conflicts of interest
• Advisory boards for Hospira and Napp• Work with Pfizer, Janssen, Abbvie, Roche
![Page 4: Biosimilars are effective and safe and should immediately replace innovator molecules in the NHS Dr Chris Deighton Consultant Rheumatologist.](https://reader036.fdocuments.in/reader036/viewer/2022082600/5a4d1b237f8b9ab059995ff8/html5/thumbnails/4.jpg)
Arguments for
• We have been using biosimilars for years• Biosimilars have to go through rigorous testing• The evidence for switching is reassuring• Biosimilars will bring prices down• Biosimilars will increase access to biologics• The multinationals will be producing
biosimilars
![Page 5: Biosimilars are effective and safe and should immediately replace innovator molecules in the NHS Dr Chris Deighton Consultant Rheumatologist.](https://reader036.fdocuments.in/reader036/viewer/2022082600/5a4d1b237f8b9ab059995ff8/html5/thumbnails/5.jpg)
Arguments for
• We have been using biosimilars for years• Biosimilars have to go through rigorous testing• The evidence for switching is reassuring• Biosimilars will bring prices down• Biosimilars will increase access to biologics• The multinationals will be producing
biosimilars
![Page 6: Biosimilars are effective and safe and should immediately replace innovator molecules in the NHS Dr Chris Deighton Consultant Rheumatologist.](https://reader036.fdocuments.in/reader036/viewer/2022082600/5a4d1b237f8b9ab059995ff8/html5/thumbnails/6.jpg)
We have been using biosimilars for years
• Changes to biologics manufacturing during and post-approval are routine
• Remicade – 43• Humira – 23• Enbrel – 22• Originator products are similar but not identical to
themselves
• (www.ema.eu)
![Page 7: Biosimilars are effective and safe and should immediately replace innovator molecules in the NHS Dr Chris Deighton Consultant Rheumatologist.](https://reader036.fdocuments.in/reader036/viewer/2022082600/5a4d1b237f8b9ab059995ff8/html5/thumbnails/7.jpg)
Comparability exercise for Manufacturing Change
• “The demonstration of comparability does not necessarily mean that the quality attributes of the pre-change and post-change product are identical, but that they are highly similar and that the existing knowledge is sufficiently predictive to ensure that any differences in quality attributes have no adverse impact upon safety or efficacy of the drug product.” EMA 2014
![Page 8: Biosimilars are effective and safe and should immediately replace innovator molecules in the NHS Dr Chris Deighton Consultant Rheumatologist.](https://reader036.fdocuments.in/reader036/viewer/2022082600/5a4d1b237f8b9ab059995ff8/html5/thumbnails/8.jpg)
Arguments for
• We have been using biosimilars for years• Biosimilars have to go through rigorous
testing• The evidence for switching is reassuring• Biosimilars will bring prices down• Biosimilars will increase access to biologics• The multinationals will be producing
biosimilars
![Page 9: Biosimilars are effective and safe and should immediately replace innovator molecules in the NHS Dr Chris Deighton Consultant Rheumatologist.](https://reader036.fdocuments.in/reader036/viewer/2022082600/5a4d1b237f8b9ab059995ff8/html5/thumbnails/9.jpg)
Biosimilars have to go through rigorous testing
• Physicochemical characterisation• Functional (biological) characterisation• Preclinical studies• Pre-registration PK/PD • Registration clinical studies• Post-registration studies
![Page 10: Biosimilars are effective and safe and should immediately replace innovator molecules in the NHS Dr Chris Deighton Consultant Rheumatologist.](https://reader036.fdocuments.in/reader036/viewer/2022082600/5a4d1b237f8b9ab059995ff8/html5/thumbnails/10.jpg)
Arguments for
• We have been using biosimilars for years• Biosimilars have to go through rigorous testing• The evidence for switching is reassuring• Biosimilars will bring prices down• Biosimilars will increase access to biologics• The multinationals will be producing
biosimilars
![Page 11: Biosimilars are effective and safe and should immediately replace innovator molecules in the NHS Dr Chris Deighton Consultant Rheumatologist.](https://reader036.fdocuments.in/reader036/viewer/2022082600/5a4d1b237f8b9ab059995ff8/html5/thumbnails/11.jpg)
Switching
• Ebbers HC et al. The safety of switching between therapeutic proteins. Expert Opin Biol Ther 2012;12(11):1473-85
• 12039 in 58 clinical trials. Human Growth Hormone, Epoetin, G-CSF
• No safety signals
![Page 12: Biosimilars are effective and safe and should immediately replace innovator molecules in the NHS Dr Chris Deighton Consultant Rheumatologist.](https://reader036.fdocuments.in/reader036/viewer/2022082600/5a4d1b237f8b9ab059995ff8/html5/thumbnails/12.jpg)
Switching
• PLANETRA, PLANETAS• 2 years follow up data• Similar safety and efficacy
• PIONEER study on GCSF chemotherapy for breast cancer
• No difference in toxicity or neutralising antibodies
![Page 13: Biosimilars are effective and safe and should immediately replace innovator molecules in the NHS Dr Chris Deighton Consultant Rheumatologist.](https://reader036.fdocuments.in/reader036/viewer/2022082600/5a4d1b237f8b9ab059995ff8/html5/thumbnails/13.jpg)
Arguments for
• We have been using biosimilars for years• Biosimilars have to go through rigorous testing• The evidence for switching is reassuring• Biosimilars will bring prices down• Biosimilars will increase access to biologics• The multinationals will be producing
biosimilars
![Page 14: Biosimilars are effective and safe and should immediately replace innovator molecules in the NHS Dr Chris Deighton Consultant Rheumatologist.](https://reader036.fdocuments.in/reader036/viewer/2022082600/5a4d1b237f8b9ab059995ff8/html5/thumbnails/14.jpg)
Arguments for
• We have been using biosimilars for years• Biosimilars have to go through rigorous testing• The evidence for switching is reassuring• Biosimilars will bring prices down• Biosimilars will increase access to biologics• The multinationals will be producing
biosimilars
![Page 15: Biosimilars are effective and safe and should immediately replace innovator molecules in the NHS Dr Chris Deighton Consultant Rheumatologist.](https://reader036.fdocuments.in/reader036/viewer/2022082600/5a4d1b237f8b9ab059995ff8/html5/thumbnails/15.jpg)
Biosimilars are effective and safe and should immediately replace innovator molecules in the
NHS
Dr Chris DeightonConsultant Rheumatologist
![Page 16: Biosimilars are effective and safe and should immediately replace innovator molecules in the NHS Dr Chris Deighton Consultant Rheumatologist.](https://reader036.fdocuments.in/reader036/viewer/2022082600/5a4d1b237f8b9ab059995ff8/html5/thumbnails/16.jpg)