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Pfizer Will Not Launch EU Adalimumab

Despite Expected Imminent Approval For Amsparity Biosimilar To Humira

 
• By Dave Wallace

Pfizer has announced that it does not plan to market its Amsparity adalimumab biosimilar in Europe despite it having been endorsed by the EMA in December and being in line for an imminent approval from the European Commission.

Bad weather
Pfizer cited ‘unfavorable conditions’ as the reason for its decision • Source: Shutterstock

Pfizer has announced that it will not launch its Amsparity (adalimumab) biosimilar in Europe, just weeks after the rival to Humira received a formal endorsement from the European Medicines Agency’s Committee for Medicinal Products for Human Use, recommending granting a pan-European marketing authorization.

The CHMP nod puts Amsparity in line for an imminent approval from the European Commission, which is responsible for issuing final centralized marketing authorizations and typically acts on CHMP positive opinions within 67 days

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