FDA Approves 10th Adalimumab Biosimilar, Simlandi

After receiving several complete response letters (CRLs), Alvotech has officially received FDA approval for its adalimumab biosimilar (AVT02; Simlandi), making it the first US approval for the company and 10th biosimilar referencing Humira (adalimumab). The product was also approved as an interchangeable biosimilar.

Alvotech has had to deal with significant challenges to get approval for its biosimilar portfolio, including receiving 3 CRLs regarding its Iceland-based manufacturing facility, of which 2 were for AVT02 and 1 was for AVT04 (ustekinumab biosimilar). The FDA has never found any issues with the biosimilar candidates themselves or Alvotech's data package.

The US commercialization and marketing of the product will be conducted by Teva Pharmaceuticals as part of an exclusive partnership. Teva Pharmaceuticals also recently rejoined the Biosimilars Forum as an official member.

"The approval of Simlandi marks the first high-concentration, citrate-free biosimilar to Humira with [interchangeability] status,” said Eric Hughes, executive vice president of global research and development and chief medical officer at Teva, in a statement. "Biosimilars create opportunities for cost savings across the healthcare system and introduce additional treatment options for patients. This approval marks an important milestone for Teva and Alvotech’s partnership to collaborate on seven biosimilars and expand the availability, access, and uptake of biosimilars in the U.S.”

AVT02 has also been approved in some international markets, including the European Union, where it was approved by the European Commission in December 2021 and is marketed as Hukyndra. It was also approved in Canada in January 2022, where is marked as Simlandi, and Australia in November 2022, where it’s marketed under 2 brand names: Ciptunec and Ardalicip.

Adalimumab products are used to treat a number of inflammatory conditions, including:

• Rheumatoid arthritis in adults
• Polyarticular juvenile idiopathic arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn disease
• Ulcerative colitis
• Chronic plaque psoriasis

In 2023, 9 adalimumab biosimilars launched on the US market, including Amjevita (Amgen), Cyltezo (Boehringer Ingelheim), Hadlima (Organon/Samsung Bioepis), Hulio (Biocon Biologics), Yuflyma (Celltrion), Yusimry (Coherus Biosciences), Abrilada (Pfizer), Hyrimoz (Sandoz), and Idacio (Fresenius Kabi). Amjevita launched in January 2023, Abrilada launched in October 2023, and the rest launched in early July 2023.

Robert Wessman, chairman and CEO of Alvotech, added,“This approval is an important milestone in Alvotech’s journey to offer broader access worldwide to more affordable biologics, following approvals of our biosimilars in other global markets. We strongly believe that biosimilars are important in addressing inflationary pressures in the healthcare system across all markets, especially in the U.S. where biologics represent well over 40 percent of all pharmaceutical spending. An interchangeable citrate-free, high-concentration biosimilar adalimumab has the potential to change the market dynamics in a rapidly evolving environment for biosimilars in the U.S.”

Simlandi is the third adalimumab biosimilar—and eighth overall—to be approved with interchangeability. The other adalimumab biosimilars with interchangeability are Cyltezo and Abrilada. Samsung Bioepis with Organon and Celltrion are working on getting the designation for Hadlima

and Yulfyma, respectively.

Interchangeability, a regulatory status exclusive to the United States, permits pharmacy benefit biosimilars to be substituted for a reference product or another biosimilar without necessitating physician approval, subject to state laws. Its purpose is to enhance patient access and convenience in obtaining prescriptions.

Additionally, AVT02 is a citrate-free, high-concentration adalimumab biosimilar. The citrate-free element allows for less injection site pain for patients and the high-concentration formulation allows for a higher volume administration, meaning patients will require less doses.

Simlandi is also the first high-concentration adalimumab biosimilar to have an interchangeability label.