FDA okays interchangeable Amgen biosimilar of J&J's Stelara
31 Oct 2023
Drug ApprovalPatent InfringementPatent ExpirationBiosimilar
The FDA on Tuesday approved Amgen's Wezlana (ustekinumab-auub) as an interchangeable biosimilar to Johnson & Johnson's dual IL-12 and IL-23 inhibitorIL-23 inhibitor Stelara (ustekinumab). Similar to the reference product, Wezlana is cleared to treat multiple inflammatory conditions, including plaque psoriasis and active psoriatic arthritis in adults and paediatric patients, as well as Crohn's disease and ulcerative colitis in adults.
The FDA said its approval was based on a review of data demonstrating that Wezlana is "highly similar" to Stelara, with no clinically meaningful differences in terms of safety, purity and potency. "Evidence included comparisons of the products on an analytical level using an extensive battery of chemical and biological tests and biological assays that confirmed similarity in the structural and functional features of Wezlana and Stelara, and comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data," the agency said.
It also evaluated evidence indicating that Wezlana met other legal requirements to be considered interchangeable with Stelara at the pharmacy level.
Follows patent settlement
Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars in the FDA's Center for Drug Evaluation and Research, said "this approval can empower patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost."
Earlier this year, Johnson & Johnson settled a patent infringement lawsuit against Amgen regarding Wezlana, also known as ABP 654. The terms of that deal were confidential, but allow Amgen to launch its Stelara biosimilar in the US "no later than January 1, 2025."
More recently, Johnson & Johnson also reached a settlement agreement with Fresenius Kabi and Formycon regarding their biosimilar version of Stelara. Under that deal, the companies will be able to market the Stelara biosimilar, dubbed FYB202, in the US no later than mid-April 2025, if approved by the FDA.
Stelara posted sales of $2.9 billion in the third quarter, up nearly 17% from the year-ago period.
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