alliance for safe biologic medicines & pennsylvania bio biosimilars policy forum
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Alliance for Safe Biologic Medicines & Pennsylvania Bio BIOSIMILARS POLICY FORUM ENSURING PATIENT SAFETY. August 17, 2011. Examples of FDA Approved Biologics. Source: New England Journal of Medicines, “Developing the Nation’s Biosimilars Program,” August 4, 2011. - PowerPoint PPT PresentationTRANSCRIPT
Alliance for Safe Biologic Medicines & Pennsylvania Bio
BIOSIMILARS POLICY FORUMENSURING PATIENT SAFETY
August 17, 2011
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Examples of FDA Approved Biologics
Source: New England Journal of Medicines, “Developing the Nation’s Biosimilars Program,” August 4, 2011
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Making Aspirin (acetylsalicylic acid)
Source: Bryan A. Liang, Regulating Follow-On Biologics, Harvard Journal on Legislation, vol. 44 (2007)
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*This is also known as molecular mass, which is the sum of the atomic masses of all the atoms of the molecule
Source: Bryan A. Liang, Regulating Follow-On Biologics, Harvard Journal on Legislation, vol. 44 (2007)
Molecule Weight*
aspirin 180
amino acid fundamental building block for a protein
75-204
insulin 5,800
growth hormone 22,000
erythropoietinstimulates red blood cell production
30,000
daclizumab suppresses the immune system for transplant patients
142,600
Molecular Weights
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Source: New England Journal of Medicines, “Developing the Nation’s Biosimilars Program,” August 4, 2011
Molecule Comparison: Aspirin vs. Biologic Monoclonal Antibody
CH3
O
CH3OH
CH3
O
CH3COCH3
CH3
OH
OH6
Source: Bilao LLC, 2008
Hormones
CH3
O
CH3OH
CH3
O
CH3COCH3
CH3
OH
OH
Testosterone
Progesterone
Estradiol
Source: Bilao LLC, 20087
Sometimes, Small Differences Can Have Profound Effects
PravastatinLovastatin Simvastatin
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Cholesterol Drugs
FluvastatinAtorvastatin Cerivastatin
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Patient safety is the priority• Biologics are complex compounds made from living
cells and have highly intricate structures that are not easily understood, characterized or replicated.
• Patient safety must preeminently guide regulatory decisions.
Doctors must make medical decisions• Patients and doctors together should carefully decide
the best course of treatment.
• Medical decisions should be made in doctors’ offices and not by legislators and regulators.
Biosimilar Policy Considerations
Leveraging what we know• A science-based approach must be used to
establish the pathway for biosimilars.
• Biosimilars are more complex than generics, and therefore Hatch/Waxman does not apply.
• Need to model EU’s science-based approach, but improve to eliminate mistakes.
Pharmacovigilance is essential• There must be a robust traceability system for
biosimilars once approved.
• A common-sense approach to tracking biosimilars must be used to ensure patient safety.
Alliance for Safe Biologic Medicines & Pennsylvania Bio
BIOSIMILARS POLICY FORUMENSURING PATIENT SAFETY
August 17, 2011