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# Panel to Discuss Amgen’s Humira Biosimilar
- URL: https://www.fdaweb.com/panel-to-discuss-amgens-humira-biosimilar/
- Published: 2016-06-14T12:00:00.000Z
- Updated: 2026-09-14T21:09:22.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135940

*Federal Register* Notice: FDA will hold a meeting of the Arthritis Advisory Committee 7/12, from 7:30 a.m. to 5 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss an Amgen BLA for a proposed biosimilar to AbbVie Inc.'s Humira (adalimumab). The proposed indications for this product are: **(1)** Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs)); **(2)** reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older (alone or in combination with methotrexate); (3) reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (alone or in combination with non-biologic DMARDs); **(4)** reducing signs and symptoms in adult patients with active ankylosing spondylitis; **(5)** reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy (ABP 501 would be indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab); **(6)** inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (the effectiveness of ABP-501 would not be established in patients who have lost response to or were intolerant to TNF blockers); and (7) treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate (only to be administered to patients who will be closely monitored and have regular follow-up visits with a physician). Contact **Moon Hee V. Choi**, (301) 796-9001\. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-06-14/pdf/2016-14017.pdf?ref=fdaweb.com)