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Investing.com -- Shares of Teva Pharmaceutical (TADAWUL:2070) Industries Ltd ADR (NYSE:TEVA) surged 6.2% while Alvotech SA (NASDAQ:ALVO) climbed 3.5% in premarket trading today, following the U.S. Food and Drug Administration’s (FDA) approval of SELARSDI™ as interchangeable with the reference biologic Stelara®. This approval, effective from April 30, 2025, covers all presentations matching the reference product.
SELARSDI, developed in partnership by Teva and Alvotech, is indicated for the treatment of various immune-mediated and inflammatory conditions, including moderate to severe plaque psoriasis, active psoriatic arthritis in adults and children over six, and moderately to severely active Crohn’s disease and ulcerative colitis in adults. The FDA’s designation of interchangeability implies that SELARSDI can be substituted for the reference drug without the intervention of the healthcare provider who prescribed the reference product.
Teva’s Senior Vice President, U.S. Biosimilars, Thomas Rainey, remarked on the significance of this development, highlighting the company’s expanding biosimilars portfolio and its potential to drive growth as Teva embarks on the next phase of its strategy. Anil Okay, Chief Commercial Officer for Alvotech, also emphasized the importance of interchangeability in increasing patient access to affordable treatments and reducing healthcare costs.
The approval of SELARSDI follows the strategic partnership between Teva and Alvotech, formed in August 2020, which focuses on the commercialization of five biosimilar product candidates. This partnership was extended in July 2023 to include two additional biosimilars. To date, two biosimilars from this partnership have been approved by the FDA with interchangeability status, with SELARSDI being the latest.
Furthermore, the FDA is currently reviewing Biologics License Applications for three more biosimilar candidates from Alvotech, with expected approval dates in the fourth quarter of 2025. These developments underscore the companies’ commitment to expanding their biosimilar offerings and their potential impact on the pharmaceutical market.
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