Alvotech and teva announce filing acceptance of u.s. biologics license applications for avt05, a proposed biosimilar to simponi® and simponi aria® (golimumab)

Reykjavik, iceland and parsippany, n.j., jan. 27, 2025 (globe newswire) -- alvotech (nasdaq: alvo), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and teva pharmaceuticals, a u.s. affiliate of teva pharmaceutical industries ltd. (nyse and tase: teva), today announced that the u.s. food and drug administration (fda) has accepted for review biologics license applications (bla) for avt05, alvotech's proposed biosimilar to simponi® and simponi aria® (golimumab), which are prescribed to treat a variety of inflammatory conditions. these are the first u.s. bla filing acceptances announced for a biosimilar candidate to golimumab. the fda review process for these applications is anticipated to be completed in the fourth quarter of 2025.
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