HUMIRA BIOSIMILAR MARKET ANALYSIS

Market News

Recent Developments

New product

• Abrilada (adalimumab-atto): ABRILADA is a citrate-free biosimilar to humira for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis. On October 5, 2023, the U.S. FDA granted interchangeability to Abrilada (adalimumab-afzb), the second adalimumab biosimilar to receive the designation.
• YUSIMRY (adalimumab-aqvh): YUSIMRY (adalimumab-aqvh), a biosimilar of humira (adalimumab), is a tumor necrosis factor (“TNF”) blocker indicated to reduce the signs and symptoms of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis, and to treat crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa. On July 03, 2023, Coherus BioSciences, Inc., a commercial-stage biopharmaceutical company, announced that YUSIMRY (adalimumab-aqvh) is available for commercial sale in the U.S. at a list price of US$ 995 per carton for two 40 mg/0.8 mL autoinjectors, representing a discount of more than 85% to humira (adalimumab), currently priced at US$ 6,922 per carton of two pens.
• AMJEVITA (adalimumab-atto): AMJEVITA is a biosimilar to Humira (adalimumab), an anti-TNF-α monoclonal antibody. The active ingredient of AMJEVITA is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as humira. On January 31, 2023, Amgen, a U.S. multinational biopharmaceutical company, announced AMJEVITA (adalimumab-atto), a biosimilar to humira (adalimumab), is available in the U.S.

Acquisition and partnerships

• On July 24, 2023, Teva Pharmaceuticals, Inc., a global leader in generic and innovative medicines and Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced that they have agreed to expand their existing strategic partnership agreement. Teva Pharmaceuticals, Inc. will also acquire subordinated convertible bonds to be issued by Alvotech. The partners continue working closely on matters concerning pending approval in the U.S. for AVT02, an interchangeable high-concentration biosimilar candidate for humira (adalimumab). The existing strategic partnership agreement also includes four other biosimilar candidates, one of which is AVT04, a proposed biosimilar for Stelara (ustekinumab), which is  pending U.S. Food and Drug Administration (FDA) approval.
• On June 05, 2023, Rani Therapeutics Holdings, Inc., a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, announced that the company has expanded its partnership with Celltrion, Inc., a biopharmaceutical company, by entering into an agreement for the development of RT-105, an orally administered adalimumab biosimilar. Rani Therapeutics Holdings, Inc.,’s first partnership with Celltrion, for the development of RT-111, an orally administered ustekinumab biosimilar, was announced in January, 2023. Under the terms of the new license and supply agreement, Celltrion will exclusively supply to Rani Therapeutics Holdings, Inc., the adalimumab biosimilar drug substance (CT-P17) which is required for RT-105. Rani Therapeutics Holdings, Inc., granted an exclusive license to use CT-P17 in the development and commercialization of RT-105, and Celltrion is granted a right of first negotiation to acquire worldwide rights to RT-105 following a Phase 1 study.
• On June 01, 2023, Mark Cuban Cost Plus Drug Company, a public benefit corporation, and Coherus BioSciences, Inc., a global biosimilar company, announced plans to offer Mark Cuban Cost Plus Drug Company customers YUSIMRY (adalimumab-aqvh), a biosimilar of HUMIRA (adalimumab injection), in July 2023. Mark Cuban Cost Plus Drug Company plans to offer YUSIMRY to its customers at a price of US$ 569.27 plus dispensing and shipping fees starting in July 2023.