Mylan Partner Mabion Withdraws Rituximab In EU
US Firm Had Been Hopeful Of Launch This Year
Mabion’s European applications for biosimilar rituximab have been withdrawn, shortly after partner Mylan indicated it was hopeful of potential market entry this year, with a change of strategy necessitating a new application be filed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.
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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.
Mylan says its ‘durable’ business model has helped it to withstand pressures from adverse industry trends in 2019, boosted by $1bn in sales from newly-launched products. However, negative currency effects cut the firm’s sales growth from 3% at constant currencies to 1% as reported.
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.