Thursday, April 22, 2010

Concerns beyond FDA Approval for Biosimilars

In a recent article at the Association of Corporate Council, they look at a few of the facts beyond the FDA's jurisdiction for decisions.

Their key aspects:
-the availability of biosimilars will put pressure on biologic drug manufacturers
-which have not had to grapple with the same limited marketing exclusivity periods
-patent cliffs for biologics that small molecule drugs have been subject to for two decades.

What do you think about these three issues? While the FDA has the key to bring biologics to market, what about the limited marketing exclusivity periods? Are these the things you are most concerned about? What other concerns does your company face with biologics?

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