Teva, Alvotech obtain FDA OK for Stelara biosimilar

Alvotech and Teva Pharmaceuticals have received approval from the Food and Drug Administration for Selarsdi (ustekinumab-aekn) injection as a biosimilar to Janssen's Stelara.

Designed for subcutaneous use, it is used for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older. Under the strategic partnership between Teva and Alvotech, Teva is responsible for the exclusive commercialization of Selarsdi in the United States.

“The approval of Selarsdi, which is our second biosimilar approval this year – underscores Teva’s commitment to expanding the availability, access and uptake of this important treatment option to patients in the U.S.,” said Thomas Rainey, senior vice president, U.S. market access at Teva. “The biosimilars market is growing, both globally and in the U.S., and biosimilars are a key component of delivering on Teva’s Pivot to Growth strategy. The partnership model that we’ve established enables us to leverage our commercial presence and experiences globally as we move to bring additional biosimilars to market.”

[Read more: Teva rolls out generic Nexavar tablets]

Robert Wessman, chairman and CEO of Alvotech, added, “We are delighted to announce our second biosimilar approval in the U.S., which is the thirty-eighth approved market for our biosimilar to Stelara globally. Bringing Selarsdi to market in the U.S. early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs. The development of Selarsdi leveraged our purpose-built end-to-end development and manufacturing platform for biosimilars. Being able to develop the biosimilar in the same cell type and continuous perfusion process as was used for the reference product, facilitated the development program’s success.”

[Read more: Teva rolls out generic Nexavar tablets]