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Sandoz Gets EU Nod For Higher-Strength Adalimumab

CHMP Also Endorses Generics From Accord, Sun And Viatris At January Meeting

 
• By Dave Wallace

Sandoz has received a positive opinion from the EMA’s CHMP recommending that its high-concentration 100mg/ml adalimumab biosimilar be granted a pan-European marketing authorization. Three generics were also endorsed at the CHMP’s January meeting, including a rival to Forxiga.

Thumbs Up Approval Endorsement
Sandoz has received a positive opinion on adalimumab 100mg/ml • Source: Igor Stevanovic / Alamy Stock Photo

Sandoz looks set to become the third firm to offer a high-concentration Humira (adalimumab) biosimilar in Europe, after the Committee for Medicinal Products for Human Use within the European Medicines Agency recommended granting a pan-European marketing authorization for the company’s Hyrimoz 100mg/ml version.

The European Commission typically acts within 67 days to convert CHMP positive opinions

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