By Kamal Choudhury (Reuters) -Teva Pharmaceuticals and Alvotech said on Friday they have launched a biosimilar to Johnson & Johnson’s autoimmune drug Stelara in the United States, the second in a wave of near-copies of the blockbuster treatment. J&J over the past two years has signed settlement agreements with several companies to delay the US […]
Health
Teva Pharma and Alvotech launch biosimilar to J&J’s Stelara in US
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By Kamal Choudhury
(Reuters) -Teva Pharmaceuticals and Alvotech said on Friday they have launched a biosimilar to Johnson & Johnson’s autoimmune drug Stelara in the United States, the second in a wave of near-copies of the blockbuster treatment.
J&J over the past two years has signed settlement agreements with several companies to delay the US launches of Stelara, which has been its top-selling drug since 2019. The first biosimilar, Amgen’s Wezlana, was launched in January this year.
Biocon Biologics is set to launch its version of the drug sometime this month, while Fresenius Kabi is expected to follow with its own launch in April.
UBS analyst Ashwani Verma said the launch of Selarsdi “can establish the success path and playbook for more biosimilars to come.”
Teva and Alvotech’s Selarsdi, like Stelara, is approved for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn’s disease and ulcerative colitis.
Stelara brought in revenue of $10.36 billion for J&J, making up more than 18% of the drugmaker’s total drug sales of $56.96 billion for 2024.
The U.S. Food and Drug Administration has allowed the use of Selarsdi as an “interchangeable” substitute only after April 30, when the exclusive rights for Amgen’s Wezlana, expire.
“Alvotech can adopt a more aggressive pricing strategy compared to competition,” Verma said, while forecasting that the global sales of Selarsdi could potentially reach $390 million by 2028.
Shares of Teva Pharma marginally down 1% in early morning trading, while Alvotech’s saw a 5% increase.
Alvotech is in charge of development and manufacturing of Selarsdi, while Teva holds the exclusive rights for marketing in the U.S.
Selarsdi has been launched in Canada as Jamteki, in Europe as Uzpruvo, and in Japan as Ustekinumab BS.
In August 2020, Teva agreed to exclusively market five of Alvotech’s biosimilar products in the United States. The companies extended their partnership in 2023 to include two additional biosimilars.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Shailesh Kuber)