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Patent Law

: Patent Docs

The Risk of Biogenerics

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

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By Kevin E. Noonan -- Follow-on biologic drugs, or biosimilars as they are called in Europe, are once again the subject of attempts by Congress to provide a regulatory pathway for approval. Currently, these drugs are not regulated by the Food, Drug and Cosmetic Act and hence not subject to the provisions of the Hatch-Waxman Act that promote generic versions of small molecule drugs. In this Congress, as in the last Congress, several bills have been introduced to "correct" this situation and provide a means for regulatory approval of generic versions of biologic drugs. A good deal of the debate...

Full post as published by Patent Docs on July 16, 2009 (boomark / email).

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