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Stelara biosimilar from Alvotech, Teva approved by FDA

Dive Brief:

  • Alvotech and Teva on Tuesday won Food and Drug Administration approval for Selarsdi, the second biosimilar poised to challenge Johnson & Johnson’s blockbuster psoriasis drug, Stelara.
  • The FDA cleared Selarsdi for treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and children who are at least 6 years old. The companies said they expect to begin selling the medicine on or after Feb. 21, 2025, a delayed introduction due to a legal settlement with J&J.
  • The two companies are likely to enter the market after Amgen, which won approval for an interchangeable biosimilar called Wezlana in October. Amgen is also subject to a legal settlement, and the company has said its product will launch no later than Jan. 1, 2025.

Dive Insight:

Stelara is one of many top-selling medicines that will face competition from copycat versions this decade, including a large number of biologic drugs.

AbbVie’s anti-inflammatory medicine Humira — sales of which topped $21 billion in 2022 — has been a top target for biosimilars, with 10 copycat versions cleared by the FDA. One of those medicines is Alvotech and Teva’s Simlandi, which won approval in February along with interchangeable status, which means pharmacists can directly substitute the drug for Humira.

So far, Humira has hung onto much of its market share, with AbbVie deploying rebates to preserve placement on insurers’ coverage lists. Likely reflecting that, global revenue from Humira dropped to $14.4 billion in 2023. Doctors may also be reluctant to switch patients from a name brand that’s working.

J&J faces less of an onslaught for Stelara, with just two biosimilars approved to date and both facing delayed launches. Still, the company is already seeing sales flatten out for Stelara in part due to slipping market share in psoriasis and psoriatic arthritis. And copycat versions will lead to price declines, Jessica Moore, head of investor relations, told analysts on a conference call Tuesday.

Selarsdi and Simlandi are the first two biosimilars to emerge from a strategic partnership between Alvotech and Teva originally inked in 2020 and expanded in 2023. Teva will be responsible for marketing Selarsdi in the U.S.