FDA Approves Biosimilar to Rheumatoid Arthritis Drug

Amgen’s biosimilar to Johnson & Johnson’s rheumatoid arthritis drug, Remicade, has been approved by the U.S. Food and Drug Administration. The biosimilar, Avsola, has the same chemical components, dosage form and strength as Remicade and can treat a range of autoimmune disorders. It was approved for all eligible indications of Remicade, including the treatment of bowel disease, Crohn’s disease and plaque psoriasis. The black box warning for the risks of serious infections and malignancy is similar to that of Remicade’s.