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Follow-on Biologics News Briefs - No. 10

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

By Donald Zuhn -- Affordable Health Care for America Act Placed on Senate Legislative Calendar The Affordable Health Care for America Act (H.R. 3962), which was passed by the House of Representatives on November 7th by a narrow five-vote margin (220-215), has now been placed on the Senate Legislative Calendar. The 1,990-page bill includes a section (§ 2575) providing for the establishment of a licensure pathway for biosimilar biological products, which precludes a biosimilar application from being approved "until the date that is 12 years after the date on which the reference product was first licensed," and offers an additional...

Full post as published by Patent Docs on December 01, 2009 (boomark / email).