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Latest From Approvals
A new ATMP, two generics and a biosimilar got the thumbs up this week from the European Medicines Agency’s drug evaluation committee, the CHMP. The committee also recommended one product for conditional authorization and another for a pediatric use authorization, But it turned down a multiple myeloma product, and a sea squirt-based MS drug was withdrawn from the review process.
Original new drugs and biologics recently approved by US FDA.
A biosimilar version of Amgen’s Neulasta has yet to be approved in the EU but one such product is in the later stages of review at the European Medicines Agency.
‘Outstanding Issues’ Clarified For Nine Products Nearing EU Review End – Including Neulasta Biosimilar
Ammtek, Pfizer, Portola and Roche are among the companies that will shortly find out what remaining concerns the European Medicines Agency’s key advisory panel, the CHMP, has regarding products of theirs that are nearing the end of the review pathway. Questions are also in store for the sponsor of a biosimilar version of filgrastim.
Lilly’s migraine prevention therapy, galcanezumab, is among the nine new products that companies have submitted to the European Medicines Agency for evaluation in recent weeks.
Five of the nine products that could this week be recommended for EU approval have orphan designation. The final meeting this year of the European Medicines Agency’s key scientific committee, the CHMP, is under way in London.
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