First Lucentis Biosimilar Among Drugs Awaiting Verdict On EU Approval Filings
Sponsors of several new medicines, including the first ever CAR-T for multiple myeloma, will find out this week if their products are on track to get EU marketing authorizations. Also, three sponsors might be asked to address outstanding issues about their products in the final stages of review.
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A gene therapy for multiple myeloma, a new drug for achondroplasia, and the first biosimilar version of Roche’s Lucentis are among eight products recommended for EU marketing authorization this week.
Samsung Bioepis is set to make waves with the first ophthalmic biosimilar after the European regulator recommended that its ranibizumab biosimilar Byooviz receive a pan-European marketing authorization.
Is the benefit-risk profile of tafasitamab good enough for it to be recommended for EU-wide marketing approval? Codevelopers Incyte and MorphoSys may find out this week.