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Friday, Alvotech (NASDAQ:ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd (NYSE:TEVA), announced the FDA approved Simlandi (adalimumab-ryvk) injection, as an interchangeable biosimilar to AbbVie Inc’s (NYSE:ABBV) Humira.
The biosimilar is indicated for 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.
In 2023, Humira was one of the highest-grossing pharmaceutical products in the world, with sales in the U.S. of nearly $12.2 billion.
Teva is Alvotech’s strategic partner for the exclusive commercialization of Simlandi in the United States.
Simlandi is the first high-concentration, citrate-free biosimilar to Humira that has been granted an interchangeability status by the FDA and will qualify for interchangeable exclusivity for the 40mg/0.4ml injection.
While both low-concentration and high-concentration strength biosimilars of Humira are marketed in the U.S. today, nearly 88% of U.S. prescriptions for adalimumab are for high-concentration presentation.
An interchangeable biosimilar may be substituted at the pharmacy without consulting the prescriber, much like generic drugs are routinely substituted for brand-name drugs.
As the only interchangeable adalimumab biosimilar with a high-concentration formulation, Simlandi can be substituted for Humira at the pharmacy level.
In August 2020, Alvotech and Teva partnered for the exclusive commercialization of five of Alvotech’s biosimilar product candidates. In August 2023, the partnership was extended to include two additional biosimilars and two new presentations of previously partnered products.
Monday, Teva Pharmaceutical Investments Singapore Pte Ltd (TPIS), a subsidiary of Teva Pharmaceutical Industries and Jiangsu Nhwa Pharmaceutical formed a partnership for the marketing and distribution of Teva’s Austedo (deutetrabenazine) for chorea associated with Huntington’s disease and tardive dyskinesia in adults.
“This partnership assists us with further growing AUSTEDO as a global leading brand, with over $1.2 billion in revenues in 2023…” said Mark Sabag, EVP and Head of International Markets at Teva.
Price Action: TEVA shares are up 4.81% at $13.51, and ALVO shares are up 11.6% at $17.90 during the premarket session on the last check Monday.
Photo by Ralf Liebhold via Shutterstock
