FDA Approves Mylan’s Humira Biosimilar
Hulio Version Of Adalimumab Will Have To Wait Three Years To Launch
Mylan’s Hulio has become the sixth biosimilar version of Humira to be approved by the US FDA. However, all of these adalimumab biosimilars face a wait until 2023 before they can enter the market.
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Mylan says it is closing in on $1bn in cumulative sales of its biosimilars, also disclosing its annual turnover figure from biosimilars as it reported its second-quarter results.
Japan has approved its first biosimilar rival to Humira. Mylan is set to market the Fujifilm Kyowa Kirin Biologics adalimumab biosimilar, having already launched the product as Hulio in Europe.
Settlement agreements reached by Humira biosimilar chasers Amgen, Samsung Bioepis and Sandoz in 2017 and 2018 were challenged in court by adalimumab purchasers, which alleged they formed were a part of a broader scheme to hold up competition to the multi-billion-dollar blockbuster brand in the US. But the biosimilar firms and AbbVie will not have to face the antitrust claims.