Alvotech Announces Positive Top-Line Results for Switching Study Between Proposed Biosimilar AVT02 and Humira®
Teva Pharmaceutical Industries Limited American Depositary Shares (TEVA)
Last teva pharmaceutical industries limited american depositary shares earnings: 2/13 04:01 pm
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Source: Business Wire
REYKJAVIK, Iceland--(BUSINESS WIRE)--Alvotech, a multinational biopharmaceutical company focused on the development and manufacturing of high quality biosimilars for global markets, today announced top-line results from a randomized study in patients that demonstrate bioequivalence of repeated switches between administration of Humira® (adalimumab) and Alvotech’s high-concentration biosimilar candidate, AVT02 (100 mg/mL) to administration of Humira without switching. Further, no significant differences were observed in clinical efficacy, safety or immunogenicity between the switching cohort and the reference product cohort.The purpose of the switching study is to support the potential approval of AVT02 by the U.S. Food and Drug Administration as an interchangeable product with Humira1. Alvotech is the only known company that has both developed and submitted a filing for a high-concentration biosimilar candidate to Humira, as well as conducted a switching study to support potential
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