Alvotech provides regulatory update on second biologics license application for avt02

Reykjavik, iceland, june 28, 2023 (globe newswire) -- alvotech (nasdaq: alvo), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the us food and drug administration (fda) has issued a complete response letter (crl) for alvotech's second biologics license application (bla) for avt02, a high-concentration biosimilar candidate for humira® (adalimumab). as the second of two blas submitted for avt02, this bla contained data to support approval as a high-concentration biosimilar and additional information to support the interchangeability designation.
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