Worldwide Clinical Trials | Whitepaper | May 2015

"The European Medicines Agency (EMA) released the first guidance for biosimilar production in 2005. It facilitated the initial wave of registrations for human growth hormone, epoetin, and filgrastim biosimilars. In the United States, the Biologics Price Competition and Innovation Act of 2009, which became law in 2010, provided an abbreviated biosimilars licensure pathway. It wasn’t until 2012, however, that the FDA issued three draft guidelines intended to bridge the gap and enable a biosimilar program across Europe and the U. S. Nevertheless, FDA guidance around the issues of interchangeability (ie, separate trials required?) and substitution (ie, biosimilar can be substituted for originator?) remained elusive ..."

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