Merck Prepares To Test Drive Biosimilar Pathway In The U.S.
Merck is gearing up to test the new regulatory pathway for biosimilar drugs in the U.S. and is hoping to be the first drug maker to move a biologic through the abbreviated process, Merck BioVentures President Michael Kamarck said in an interview June 28
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Of all the Big Pharma manufacturers, none seemed more optimistic about the commercial potential of biosimilars than Merck. But over the last several months, Merck shut down its BioVentures Group and skipped an FDA public meeting on the abbreviated approval pathway. Has Merck soured on biosimilars?
Merck BioVentures has signed the CRO Parexel to assist in the development of biosimilars.
While industry mega-mergers occupied readers in 2009, the focus in 2010 shifted toward several evolving policy concerns and their impact on company strategy. Among these, more companies are looking at the opportunity for biosimilars created by the health care reform law's provision of a legal framework for product approval. But early analyses suggest that there is still a lot of work to do as FDA develops a guideline for industry on an abbreviated approval pathway.