FDA approves Alvotech and Teva Pharmaceuticals’ SELARSDI as biosimilar to Stelara

In a significant development in the pharmaceutical industry, Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), have announced the approval of SELARSDI (ustekinumab-aekn) injection by the U.S. Food and Drug Administration (FDA). This approval marks SELARSDI as a biosimilar to Stelara, designed for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients aged 6 years and older. Teva Pharmaceuticals is set to handle the exclusive commercialization of SELARSDI in the United States, as part of their strategic partnership with Alvotech.

The approval of SELARSDI not only underscores Teva’s commitment to expanding treatment options in the U.S. but also highlights the growing importance of biosimilars in the pharmaceutical market, both domestically and globally. Thomas Rainey, Senior Vice President, U.S. Market Access at Teva, expressed enthusiasm about the approval, stating, “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.” This move is a key component of Teva’s Pivot to Growth strategy, leveraging its global commercial presence to bring additional biosimilars to market.

Robert Wessman, Chairman and CEO of Alvotech, also highlighted the broader implications of this approval, noting, “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.” Alvotech utilized a purpose-built end-to-end development and manufacturing platform to develop SELARSDI, maintaining the same cell type and continuous perfusion process as used for the reference product, Stelara.

SELARSDI’s approval was based on a comprehensive clinical development program, which included significant data demonstrating its efficacy and safety. The primary study involved 581 patients across Europe, focusing on the Psoriasis Area and Severity Index (PASI) improvement from baseline to week 12. Another phase I study compared the pharmacokinetics, safety, tolerability, and immunogenicity of SELARSDI against the U.S.-licensed and EU-approved Stelara, involving 294 healthy adult volunteers in Australia and New Zealand.

With Stelara’s sales nearing $7 billion in the U.S. in 2023, the introduction of SELARSDI as a biosimilar promises substantial cost savings and expands treatment options within the healthcare system. This approval is part of Alvotech and Teva’s broader strategic partnership, which has previously seen the FDA approval of SIMLANDI®, another significant biosimilar, in February 2024.

The FDA’s approval of SELARSDI represents a pivotal moment in the biosimilars market, showcasing the potential for these therapies to provide effective, lower-cost alternatives to established biologics. As the healthcare industry continues to embrace biosimilars, companies like Alvotech and Teva are well-positioned to lead this shift, significantly impacting patient care and cost management in inflammatory diseases. The strategic collaboration between Alvotech and Teva exemplifies how leveraging shared expertise and resources can accelerate the availability of crucial treatments to the market, ultimately benefiting the broader healthcare landscape.