After three-year delay, FDA finalizes guidance documents on biosimilarity


The US Food and Drug Administration (FDA) today finalized three long-sought guidance documents outlining its expectations for near-exact copies of existing biological drugs known as biosimilars. The trio of guidance documents were first released in draft form for comment in February 2012, and were the first policy documents to be released by FDA after the 2010 passage of the Biologics Price Competition and Innovation Act (BPCI) under the Patient Protection and Affordable Care Act (PPACA/Obamacare). Now, more than three years later, the FDA has finalized the same three guidance documents…

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