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Wrapping up the Issues from the FDA Hearings on Biosimilars

By Donald Zuhn, Kevin Noonan, Chris Singer, Sherri Oslick, and Jason Derry

By James DeGiulio -- Earlier this month, we reported that a major issue discussed at the Food and Drug Administration's public hearings on the implementation of the Biologics Price Competition and Innovation Act (BPCIA) concerned the standards that the FDA will require for clinical testing of biosimilars (see "Clinical Trial Requirements Are Top Issue at FDA Hearings on Biosimilars"). Balancing patient safety with allowing biosimilars to enter the market without cost-prohibitive extensive testing will likely be a major issue for the FDA to unravel going forward. However, other topics at the hearings materialized as innovators, biosimilar advocates, and patient groups...

Full post as published by Patent Docs on November 22, 2010 (boomark / email).