Of the more than 2,000 pages which make up the “Affordable Care Act of 2010”, a scant 46 address the multi-billion dollar issue of bringing “generic” versions of biotech drugs to market, and only 24 of them are devoted to how the Food & Drug Administration is supposed to do that. Those 24 pages grant the FDA a great deal of discretion in how to create a new approval pathway for biosimilars, including leaving to agency personnel the task of defining when a branded biologic and its generic are “highly similar” enough to permit release of the generic.
These are just a few of the many things we learned yesterday from the panelists in WLF’s media briefing program, “An Approval Pathway for ‘Biosimilars’: What’s Next for FDA on Health Care Law Implementation?” The full video of the program is available in WLF’s video archive.
Our moderator, Michael McCaughan, editor of the RPM Report and the In Vivo blog, offered insightful prefatory comments and introduced the other panelists, Kathleen M. Sanzo of Morgan, Lewis & Bockius LLP and Robert A. Dormer of Hyman, Phelps & McNamara P.C. Kathy provided a PowerPoint handout, which can be downloaded here.
Mike offered this assessment of the program at In Vivo.