Keeping you updated on the latest Medicare and Part D news

FDA Panel Unanimously Recommends Approval of Biosimilar Drug

Leave a comment

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.



Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )


Connecting to %s