Amgen's Biosimilar to Adalimumab Approved, Market Penetration Uncertain

AbbVie’s blockbuster arthritis medication, adalimumab (Humira), now has an FDA-approved competitor: Amgen’s adalimumab-atto, also called Amjevita. The biosimilar has been approved for the following indications:

• Moderate to severely active rheumatoid arthritis
• Active psoriatic arthritis
• Active ankylosing spondylitis
• Moderately to severely active Crohn’s disease
• Moderately to severe plaque psoriasis
• Moderately to severely active ulcerative colitis
• Moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and old

The approval brings up the count of approved biosimilars in the US market to 4, following last month’s approval of Novartis’ biosimilar to Amgen’s Enbrel.

Serious side effects associated with adalimumab-atto include infections and malignancies. Expected adverse events include infections and injection site reactions, and the product label includes a Boxed Warning on the possibility of infections. The label also includes a warning on the possibility of malignancies in children and adolescents treated with inhibitors of tumor necrosis factor, including adalimumab.

While adalimumab-atto is expected to be sold by Amgen at a discounted price compared with the reference product, patent litigation by AbbVie might hold the product off the market till 2022. “Humira is protected by many patents covering all aspects of its manufacture, formulation and indications and the patents are the result of AbbVie’s investment in biologic innovation and the unique attributes of Humira,” the company told FiercePharma earlier this year. AbbVie has sued Amgen to protect 10 patents on Humira, and has threatened to up that number citing infringement of 51 additional patents.

Analysts however believe that Amgen might make the drug available much earlier, a move that could result in an 18% reduction in sales of Humira, which boasted fourth quarter earnings in 2015 of $3.72 billion and a total annual revenue of more than $14 billion.

It would be interesting to see how Amgen plans to price their product compared to the reference, which costs anywhere between $1800 to $2400 per month without insurance. With a growing national debate over the price of prescription drugs, and pharmacy benefit managers excluding or placing restrictions on the use of more expensive medications when alternatives are available, patients as well as the healthcare industry will be waiting on the price of adalimumab-atto.

Other companies working to develop biosimilar adalimumab products include Novartis, Merck-Samsung Bioepsis, and Baxalta-Momenta.