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Roll Call Authors Unite against Current Follow Biologics Legislation

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

By Donald Zuhn -- Earlier this month, James Love and James Glassman, writing in the Congressional newspaper Roll Call, expressed "alarm" regarding recent Congressional action concerning the establishment of a follow-in biologics (FOB) regulatory pathway ("Don't Kill Competition for High-Tech Drugs"). That action included the recent passage by the House Committee on Energy and Commerce of a health care reform bill containing a licensure pathway for biosimilar biological products that would prevent the FDA from approving a biosimilar application until 12 years after the date on which the reference product (i.e., the innovator biologic) was first licensed (see "House Committee...

Full post as published by Patent Docs on September 21, 2009 (boomark / email).