Alvotech, Teva get hard-fought Humira biosim approval

Feb. 26, 2024

Alvotech and the U.S. arm of Teva Pharmaceuticals announced that the U.S. FDA has approved the Simlandi injection, as an interchangeable biosimilar to Humira.

Like Humira, Simlandi is approved for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis.

The approval makes Simlandi the first high-concentration, citrate-free biosimilar to Humira that has been granted an interchangeability status by the FDA. According to Alvotech, while both low-concentration and high-concentration strength biosimilars of Humira are marketed in the U.S. today, nearly 88% of prescriptions for adalimumab are for the high-concentration version.

The win did not come easy for Alvotech. The biosimilar specialist was one of the last companies to ink a deal with AbbVie, agreeing to wait until July 2023 to launch its biosimilar. The companies had been in a lawsuit tug-o-war, with Alvotech accusing AbbVie of employing a “wrongful monopoly” on the drug and AbbVie later accusing Alvotech of recruiting one of its manufacturing execs to steal Humira trade secrets.

In addition, Simlandi was thrice rejected due to issues at Alvotech's Reykjavik facility. The first time came in September 2022, following a 483 from a March inspection. The 483 listed 13 observations, including mold and microbial excursions, as well as issues with the sterility of stoppers used in packaging. Two more CRLs for AVT02 followed, one in April 2023 and another one in June 2023, all attributed to the facility.

2023 was expected to be a 'watershed moment' for biosimilars, with multiple lower-cost adalimumab versions launching referencing the branded drug that had amassed over $200 billion in revenue. However, at one year post-loss of exclusivity, the average biosimilar adoption rate is 22% — but adalimumab is sitting at under 2%.

Lack of interchangeability was cited as one reason for the sluggish uptake, as an interchangeable designation means a biosim can be substituted for its reference product at the pharmacy, without approval from the prescribing physician.

The Alvotech-Teva biosim will be the third interchangeable biosim to hit the market. Boehringer Ingelheim’s Cyltezo was the first FDA-approved interchangeable biosimilar to Humira. It became commercially available in July 2023. Pfizer’s Abrilada nabbed the interchangeable designation as well, hitting the market in October 2023.