Roche’s Novel Ranibizumab Implant Among Myriad New Filings In EU
US Approval For Port Delivery System Expected Late 2021
The European Medicines Agency has added 13 new drugs to its list of products that are under review for potential pan-EU marketing approval.
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Roche insisted that “biosimilar competition is only one factor in the overall picture,” as it reported another set of depleted figures for its three powerhouse biologic brands: Avastin, MabThera/Rituxan and Herceptin.
If approved, Roche’s bispecific antibody could become the first in a new class of medicines in years for treating macular degeneration and diabetic macular edema.
EU marketing authorization applications from Bayer for copanlisib and from Takeda for maribavir will be reviewed under standard timelines at the European Medicines Agency.