In a landmark lawsuit over the first biosimilar application, Amgen is suing Sandoz for unlawfully refusing to follow the patent resolution protocol laid out by the rules of the Biologics Price Competition and Innovation Act of 2009 . According to the rules of BPCIA, Sandoz was required to share with Amgen its 351 biologics license application for filgrastim and its manufacturing processes and dossier for the product within 20 days of FDA's decision to approve the product.
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http://ift.tt/108jtTh
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