Sandoz Lines Up Higher-Strength Adalimumab In Europe
Filing For 100mg/ml Version Of Hyrimoz Biosimilar Rival To Humira Accepted By EMA
Sandoz is looking to enter the European market for high-concentration adalimumab after announcing EMA acceptance of its filing for a 100mg/ml version of its Hyrimoz biosimilar. Celltrion and Stada/Alvotech already have higher-strength rivals to Humira available in Europe.
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Looking back over the second quarter of 2022, Generics Bulletin executive editor Dave Wallace picks out highlights from April to June that include multiple first generic and biosimilar launches, some noteworthy executive moves, further preparation for biosimilar competition to Humira in the US, and a major European industry conference.
180 Life Sciences has found that adalimumab can effectively treat nodule hardness and size in Dupuytren’s disease during a Phase IIb study. But, the company’s CEO Jim Woody tells Generics Bulletin, regulators in the UK and US have requested more information before they will press on with authorization.
Celltrion has secured a US launch date for its higher-strength adalimumab biosimilar, Yuflyma, through a settlement with AbbVie. However, the company will face a number of other Humira rivals in 2023.