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Amgen Gets European Recommendation For Approval For ABP 501

Thousand Oaks-based biotech Amgen announced this morning that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has given its ABP 501 (Biosilmilar Adalimumab) compouned a positive opinion for treatment of certain inflammatory diseases in adults. The company said the CHMP opinion is the first time an adalimumab biosimilar has been recommended for approval in the EU. The compound is being aimed at treating such conditions as rheumatoid arthritis, psoriatic arthritis, Crohn's disease, ulcerative colitis, and a host of other related inflammatory diseases. Amgen said the next step is review by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).


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