Amgen's Petition To Require Patent Exchange Certification Denied

March 30, 2015 at 1:26 PM
FDA denied Amgen's petition urging the agency to require all future biosimilar applications to include a certification that the company will participate in the so-called patent dance exchange with the reference product sponsor, blocking another attempt by Amgen to require participation in the information exchange process. FDA left the determination of whether the exchange process was mandatory up to results of litigation between Amgen and Sandoz “that may clarify how section 351(l) should be interpreted.” This district court ruling last...


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