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Biosimilars Law Blog

Monthly Archives: April 2015

Posted in News & Events

The First Biosimilar in the U.S. – Five Questions Left Open by FDA

Last month, the Food and Drug Administration (FDA) approved the first U.S. biosimilar, Zarxio (filgrastim-sndz). Since the positive vote of FDA’s Oncologic’s Drugs Advisory Committee at its January meeting, approval of Sandoz’s biosimilar to Amgen’s Neupogen for all 5 Neupogen indications was anticipated. This landmark event comes almost exactly 5 years after passage of the

Posted in Global Comparisons, News & Events

Netherlands MEB revises position on biosimilars and interchangeability

The Dutch Medicines Evaluation Board (MEB) published a new position on biosimilars, in which it accepts substitution or interchangeability of biosimilars under certain conditions. The MEB’s revised position on biosimilars was published on 31 March 2015 and replaces its previous position of 2010. The 2010 position provided that patients should be kept at the same