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Insmed Announces Bioequivalent G-CSF Biologic

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

By Kevin E. Noonan -- Insmed Inc. announced today that a just-completed clinical trial showed that its INS-19 product, a recombinant human granulocyte colony stimulating factor (G-CSF) was "bioequivalent" to Amgen's FDA-approved Neupogen®, a product used for treating neutropenia, a blood deficiency disorder associated with, inter alia, chemotherapeutic drug treatment. One of the key points of contention between those in favor of legislation permitting so-called "follow-on biologic" drugs (also termed "biosimilars") is the need for the drug to have the same safety, efficacy, and other characteristics of the innovator molecule. There is real reason for concern in this regard. Unlike...

Full post as published by Patent Docs on July 11, 2008 (boomark / email).