Following Follow-On Biologics Legislation

Law360, New York (May 31, 2011, 4:24 PM EDT) -- The recently passed Biologics Price Competition and Innovation Act (BPCIA) is the first attempt to provide an abbreviated pathway for U.S. Food and Drug Administration approval for biological products that are biosimilar or interchangeable with a previously FDA-approved biologic product, in an effort to increase the presence of follow-on biologics in the marketplace. Although still in its infancy, the field of follow-on biologics is expected to have a significant impact on the biotech/pharma landscape.

Both generic drugmakers and branded drugmakers have made biosimilars a priority for...
To view the full article, register now.