1 / 10

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.

katoka
Download Presentation

Alliance for Safe Biologic Medicines & Pennsylvania Bio BIOSIMILARS POLICY FORUM

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related