Amgen Receives Positive CHMP Opinion for its Biosimilar Adalimumab

Amgen today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has “adopted a positive opinion” for marketing of Amgen’s biosimilar adalimumab, “recommending approval for all available indications.”  Amgen’s biosimilar adalumimab was approved in the United States on September 23, 2016.  The CHMP’s opinion is the first time a biosimilar adalimumab has been recommended for approval in the EU.