AcuPartD

Keeping you updated on the latest Medicare and Part D news

FDA Panel Unanimously Recommends Approval of Biosimilar Drug

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For the first time, an FDA expert panel has recommended the approval a biosimilar drug, which is a generic version of a biologic drug. The biosimilar, EP2006, is a close copy of the cancer therapy drug Neupogen. EP2006 was approved in Europe in 2009, back when the Untied States lacked a regulatory pathway for biosimilars. However, that framework has been built up since 2010, and EP2006 could open the biologic drug market to lower-cost competition. Biosimilars have the potential for significant savings; according to Express Scripts, biosimilars are generally about a third cheaper than their brand name counterparts, and EP2006 alone could reduce drug costs by $5.7 million over the next decade.

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