The Growing Wave of Biosimilars for Autoimmune Diseases

When the first adalimumab (Humira) biosimilar launched at the end of January, it was just the beginnings of a wave of coming biosimilars for anti-inflammatory biologics.

Anti-inflammatory biologics bring a heavy cost, but there is also a wave of autoimmune biosimilars on its way that brings the opportunity to reduce drug costs in this area, according to a report from CVS Health.1

Treatments for autoimmune conditions are the largest driver of spend for plan sponsors. “While autoimmune conditions affect only 1% of commercially insured plan members, the category accounted for 42% of specialty spend in 2022,” the reported noted.

The wave of adalimumab (Humira) biosimilars has already begun with the launch of Amjevita from Amgen on January 31. At least 7 other adalimumab biosimilars will hit the US market in 2023. Adalimumab is approved to treat a variety of diseases: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, Crohn disease, and ulcerative colitis.

Next up in the space? Ustekinumab (Stelara) biosimilars. While there are currently no FDA-approved ustekinumab biosimilars in the United States, there is one from Alvotech and one from Amgen under FDA review. Decisions from the FDA are expected September 1 for Amgen and November 6 for Alvotech, according to CVS. The biosimilar from Amgen is currently in the process of seeking interchangeability status.

In addition to the 2 under FDA review, there are another 6 ustekinumab biosimilars in development. Stelara is approved to treat patients with psoriatic arthritis, plaque psoriasis, and inflammatory bowel disease. The Stelara patent expires September 2023 in the United States.

In addition, there are biosimilars in development for tociluzumab.2 Biosimilars from Celltrion and Biogen/Bio-Thera are in phase 3 trials, while MSB11456 from Fresenius Kabi is currently under review with the FDA. A decision is expected this year.

Farther down the line are biosimilars for etanercept (Enbrel). There are currently 2 approved by the FDA, but their launches have been delayed due to patent litigation. Neither are expected to reach market until 2029.

Interchangeability is expected to be an important, although not the primary, driver of biosimilar adoption. Among the FDA-approved adalimumab biosimilars, only 1 has achieved interchangeability status, although 2 are in the process and 1 that is approved is under review for interchangeability.

The potential savings that can be realized as the biosimilars all come to market can be large. The report highlighted the impact on price when Inflectra, an infliximab biosimilar, launched. When it first launched, it was at a savings of only 10% of the reference product, Remicade, but after 4 years, the competition caused the price for both the biosimilar and the reference product to drop by 50%.

“The potential for plan sponsor savings in the autoimmune category is significant due to the number of planned market entrants,” according to the CVS report.

As biosimilars enter the market, there will be formulary considerations. Placement decisions should be driven by a combination of factors: clinical appropriateness and efficacy, net cost, and product attributes.

The landscape for the autoimmune category is expected to change with potentially significant savings as biosimilar competition emerges. “Initially, we believe the lowest net cost strategy in this category will be a combination of the reference product, biosimilar competitors, and other branded products,” the report concluded.


1. CVS Health. Biosimilars in the autoimmune category: opportunities and considerations. January 30, 2023. Accessed February 16, 2023.

2. Cardinal Health. New and upcoming biosimilar launches. Updated January 18, 2023. Accessed February 16, 2023.

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