REYKJAVIK, Iceland & PARSIPPANY, N.J. - Alvotech and Teva Pharmaceuticals announced the FDA approval of SELARSDI (ustekinumab-aekn) for moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients aged 6 and older.
SELARSDI is a biosimilar to Stelara, a treatment for immune-mediated diseases. The approval marks the second biosimilar under the strategic partnership between Alvotech and Teva, with Teva handling the U.S. commercialization.
The FDA's decision was informed by a comprehensive body of evidence, including analytical and clinical data. This included a 52-week efficacy and safety study, as well as a pharmacokinetic study comparing SELARSDI with Stelara in the U.S. and Europe.
SELARSDI, developed and manufactured by Alvotech using murine cell (Sp2/0) and a continuous perfusion process, is expected to be available in the U.S. market on or after February 21, 2025, following a settlement with Johnson & Johnson (NYSE:JNJ), the manufacturer of Stelara. The biosimilar's availability is anticipated to provide cost savings and expand treatment options for patients.
Alvotech's Chairman and CEO, Robert Wessman, noted the approval as a step towards improving patient access to biologics and addressing healthcare inflation. Thomas Rainey, Senior Vice President at Teva, highlighted the growing biosimilars market and Teva's commitment to enhancing treatment availability.
Stelara's sales in the U.S. reached nearly $7 billion in 2023, suggesting a significant market for SELARSDI. Plaque psoriasis is prevalent in the U.S., and psoriatic arthritis represents a portion of juvenile arthritis cases.
This approval adds to Alvotech's biosimilar portfolio, which targets various medical conditions. The collaboration with Teva leverages their commercial presence and experience in bringing biosimilars to market.
The information presented is based on a press release statement.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.