Amgen has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ABP 501, a biosimilar candidate to AbbVie’s Humira (adalimumab). Amgen believes this is the first adalimumab biosimilar application submitted to the EMA and represents its first biosimilar submitted for approval in the EU. Adalimumab is an anti-TNF-α monoclonal antibody approved in many countries for the treatment of various inflammatory diseases. Amgen’s MAA submission includ...