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Alliance for Safe Biologic Medicines & Pennsylvania Bio BIOSIMILARS POLICY FORUM

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.

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Alliance for Safe Biologic Medicines & Pennsylvania Bio BIOSIMILARS POLICY FORUM

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  1. Alliance for Safe Biologic Medicines & Pennsylvania Bio BIOSIMILARS POLICY FORUM ENSURING PATIENT SAFETY August 17, 2011

  2. Examples of FDA Approved Biologics Source: New England Journal of Medicines, “Developing the Nation’s Biosimilars Program,” August 4, 2011

  3. Making Aspirin (acetylsalicylic acid) Source: Bryan A. Liang, Regulating Follow-On Biologics, Harvard Journal on Legislation, vol. 44 (2007)

  4. Molecular Weights *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)

  5. Molecule Comparison: • Aspirin vs. Biologic Monoclonal Antibody Source: New England Journal of Medicines, “Developing the Nation’s Biosimilars Program,” August 4, 2011

  6. Hormones OH COCH3 CH3 CH3 CH3 CH3 OH O O CH3 OH Source: Bilao LLC, 2008

  7. Sometimes, Small Differences Can Have Profound Effects COCH3 CH3 CH3 CH3 CH3 OH O CH3 OH OH Progesterone Testosterone O Estradiol Source: Bilao LLC, 2008

  8. Cholesterol Drugs Pravastatin Lovastatin Simvastatin Atorvastatin Cerivastatin Fluvastatin

  9. Biosimilar Policy Considerations • 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. • 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.

  10. Alliance for Safe Biologic Medicines & Pennsylvania Bio BIOSIMILARS POLICY FORUM ENSURING PATIENT SAFETY August 17, 2011

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