Pfizer’s Ruxience Rituximab Biosimilar Gets CHMP Nod
Positive Opinions Also Issued For Hybrids And Generics
Pfizer has received a positive opinion from the CHMP recommending granting a pan-European marketing authorization for its Ruxience rituximab biosimilar version of MabThera. At the same time, CHMP nods for hybrid medicines were received by SciPharm and Teva, while Mylan, Betapharm and Accord saw generics endorsed by the committee.
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Pfizer has received European Commission approval for the firm’s Ruxience biosimilar to Roche’s MabThera brand, including as a treatment for rheumatoid arthritis, opening the door to a three-way biosimilar fight in the European Union.
Mabion’s European applications for biosimilar rituximab have been withdrawn, shortly after partner Mylan indicated it was hopeful of potential market entry this year, with a change of strategy necessitating a new application be filed with the EMA.
Recommending new medicines for approval and allowing sponsors of others extra time to answer outstanding questions are among the many tasks on the agenda of the March meeting of European Medicines Agency's key scientific committee, the CHMP. The meeting has been taking place, remotely, this week.