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# Amgen’s Remicade Biosimilar Gains Approval
- URL: https://www.fdaweb.com/amgens-remicade-biosimilar-gains-approval/
- Published: 2019-12-06T12:00:00.000Z
- Updated: 2026-09-14T15:55:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145673

FDA has approved an Amgen BLA for [Avsola (infliximab-axxq)](https://u7061146.ct.sendgrid.net/wf/click?upn=rxX2Bk4zIZ5OmFHb0keB3-2FrLre2OQPdvBnFWFyClaJBI-2BuLv0P0jPChM7BPEJOyXFko53Ny3mUqSoWGp6Gkv219c-2FhFySMTgW5xyyAMdnEuSjn0k800-2FQk9lvGJTpHP5BH9jMCWXD6anQqvcIVreMbBZxO3N6hdk0idIUEtQWKsA3iYUKEAFlqj4OD5Xd8cI3LhgYOcK0qcJX-2Fm37NMBSHfUHCItVntVzsSml-2FhE8v4I-2BVRXTUwbdI-2B8NJdazU9-2Bkb9dvntltV0Tu-2BEn6-2FTAABXqbmgBEN7T3a9zza5aEo2qly557J6Lx0dIeJ4lHnJlqBxmNnUYUUQQSVLKu5pwpDsblUOyL-2BpvdUjMCI4rXF7S7og8qdciqilmNPeJ1hxgvb5exHFXAboISZFqBIn5Rs0PqOW8ywWfu5CnAZj-2FBH8-3D%5FnE9rxSXA5G4kxsTVkgv43tTJnmhvULg8vMtvbdZHwXFkzYqYtx2YqfH2nUNu2Fsp-2Bt0jOcO3ojZAqOtVcrkij2iHj0SLeZI-2Fra0vxzttJSyLLte5VmQZrUe2he5k2WeU7Pwtz74cItIleZo-2F4xs77pEDIpa-2BW5JNCb5-2BdBN4lrukUl-2F1a3YVcRb2MqdESiQE55TKa2eevAWIIDvL5BnQlM8hSIKv5Oj5m8GOV0t2BmDUeFPr-2B6VZTLeymgNOvev-2BgnqtBEK4yewoHkUBOcqC6P9-2F8mh6nAU5oUB241cl6WetbDauOFtGRj3IUv49prZDjJEFRRM2rOlyFEp1gM71JQ-3D-3D&ref=fdaweb.com), a biosimilar of Janssen’s Remicade, indicated for treating Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. The agency says this is the fourth biosimilar of Remicade (infliximab) to gain approval. To view the approved label for Avsola, click [here](https://www.accessdata.fda.gov/drugsatfda%5Fdocs/label/2019/761086s000lbl.pdf?utm%5Fcampaign=FDA%20Approves%20Avsola%20%28infliximab-axxq%29%2C%204th%20biosimilar%20to%20Remicade%20%28infliximab%29&utm%5Fmedium=email&utm%5Fsource=Eloqua).