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Senator Kennedy Weighs in on Biosimilar Data Exclusivity Period

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

By Kevin E. Noonan -- Yesterday, Senator Ted Kennedy (D-MA) proposed that innovator biologic drugmakers should be given up to 13.5 years of data exclusivity in any follow-on biologics legislation to be considered by Congress this session. As reported by Catherine Larkin at Bloomberg.com, the Senator's proposal was introduced as a "placeholder" that could be adopted, modified, or discarded after other Senators have the opportunity to introduce their own amendments to biosimilars legislation being prepared by the Senate Committee on Health, Education, Labor, and Pensions. Two of the three follow-on biologics bills introduced in the current Congress (H.R. 1427 and...

Full post as published by Patent Docs on July 10, 2009 (boomark / email).