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‘Outstanding Issues’ Near For Products Approaching EU Review End – Including Neulasta Biosimilar

Executive Summary

Ammtek, Pfizer, Portola and Roche are among the companies that are likely to 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 likely to be in store for the sponsor of a biosimilar version of pegfilgrastim.

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