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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Janssen/Legend Biotech's ciltacabtagene autoleucel and Ipsen's palovarotene are among the latest new medicines that have been submitted for pan-EU approval.
Cilta-cel likely will be the second BCMA-targeting CAR-T therapy approved in the US for multiple myeloma, but appears to have an efficacy advantage over BMS/bluebird’s first-to-market Abecma.
Another of Roche’s biologic blockbusters is due to bite the dust this year, the originator has confirmed, with biosimilar competition to Lucentis forecast in the second half of 2021.