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Latest From Maureen Kenny
‘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.
Considerably fewer European Medicines Agency staff members may be willing to move with the agency to Amsterdam than is being suggested, says UK industry heavyweight Mike Thompson. Letting people stay in London and work from the EMA’s existing HQ there would help avert a potential crisis, Thompson suggests, saying what’s needed among those negotiating is honesty and pragmatism.
A press conference following the announcement that the European Medicines Agency is to move from London to Amsterdam included a series of questions on the selection process and the voting itself.
Now that the European Medicines Agency knows where it is going after Brexit, the business of preparing for the move can begin. Being able to ensure business continuity during and after the relocation from London to Amsterdam will be highly dependent on the EMA’s ability to retain as many of its current staff as possible. Job losses are expected but it could be some time before it’s clear which business operations will be affected.