EMA Committee Issues Positive Opinion for Biogen’s Adalimumab Biosimilar Candidate

According to a Biogen press release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for Biogen’s Imraldi®, a proposed biosimilar to AbbVie’s Humira® (adalimumab).  The Imraldi application was submitted to the EMA by Samsung Bioepis, a joint venture between Biogen and Samsung BioLogics.  Samsung Bioepis seeks approval to market Imraldi for indications including the treatment of rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, and other conditions.

Alpna Seth, Ph.D., Senior Vice President and Global Head of the Biosimilars Business Unit at Biogen, states:  “If IMRALDI receives approval, Biogen will be the first company to have approved biosimilars of the three most prescribed anti-TNF biologic treatments in Europe.”