EC Approves Amgen’s Biosimilar Adalimumab

Approved Biosimilar Products

Amgen announced yesterday that the European Commission (EC) has granted marketing authorization for AMGEVITA (biosimilar adalimumab) in all available indications, including certain adult and pediatric inflammatory diseases.  AMGEVITA is Amgen’s first biosimilar approved by the EC.  Amgen states in its press release that “AMGEVITA was approved in the United States (U.S.) by the U.S. Food and Drug Administration on Sept. 23, 2016.  In the U.S., the brand name is AMJEVITA™ (adalimumab-atto).”  As we previously reported, AMJEVITA  is subject to pending BPCIA litigation.

Stay tuned to Big Molecule Watch for further developments.

 

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