Alvotech, Teva Enlist New Partner to Expand Access to Humira Biosimilar in US

M&A_iStock, Tippapatt

Pictured: Businessmen shaking hands after closing a deal/iStock, Tippapatt

Alvotech and Teva Pharmaceuticals on Friday announced that they have signed a new long-term agreement with an undisclosed strategic partner in order to make its Humira biosimilar Simlandi (adalimumab-ryvk) more accessible to U.S. patients.

The companies did not reveal the identity of the partner, nor did they provide details of the deal, but they indicated that the partnership between Teva and Alvotech will be unaffected. Teva will still be responsible for the commercialization of Simlandi in the U.S.

“This new partnership agreement supports our financial guidance and reflects Alvotech’s strong commitment to increasing patient access to more affordable healthcare,” Alvotech CEO Robert Wessman said in a statement.

Simlandi won the FDA’s approval in February 2024, following years of regulatory difficulties. Unlike most biosimilars to AbbVie’s blockbuster arthritis, Simlandi has been awarded the regulator’s interchangeability designation, which means that it can be substituted for the branded reference product without needing to change the prescription.

The biosimilar is also of a high-concentration and citrate-free formulation, which ensures less painful injections and a quicker onset of treatment effects.

At the time of its approval, Alvotech and Teva announced that they were working to launch Simlandi in the U.S. “imminently,” which would not only provide patients with a more affordable biologic treatment option but also help address “inflationary pressures in the healthcare system.”

Simlandi joins several other Humira biosimilars that have entered the U.S. market since January 2023. The group of competing products includes Amgen’s Amjevita, Celltrion’s Yuflyma and Boehringer Ingelheim’s Cyltezo.

However, Humira’s chief copycat competitor is Sandoz’s Hyrimoz, prescriptions for which skyrocketed in the first week of April 2024, according to an investor note from analyst firm Evercore ISI. In the week ending April 5, almost 8,300 new prescriptions for Hyrimoz were written, compared to approximately 640 in the week ending March 29.

The spike in Hyrimoz prescriptions comes after CVS Caremark, one of the country’s biggest pharmacy benefit managers, removed Humira from its major national commercial formularies on April 1, 2024. Since then, biosimilar prescriptions shot up to 36% with Hyrimoz accounting for 93% of this growth.  

Earlier this month, Samsung Bioepis released its quarterly Biosimilar Market Report, noting that as of February 2024, biosimilars have managed to capture only 4% market share while Humira still controlled 96% of the space.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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