Pfizer’s Dacomitinib And More Biosimilar Hopefuls Among New EMA Filings
There are eight new entries to the list of marketing applications filed with the European Medicines Agency, including submissions for more versions of Amgen’s Neulasta (pegfilgrastim), and a second biosimilar of Roche’s Avastin (bevacizumab).
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The labeling of several major medicines marketed in the EU is to be updated to reflect cases of serious adverse events. The European Medicines Agency’s pharmacovigilance committee has also recommended a new warning on drug-drug interactions, and asked for additional information on several other products.
Nine new products have been added to the list of products that the European Medicines Agency is reviewing for marketing authorization.
Regeneron and Shire should find out this week whether the European Medicines Agency will agree to fast-track its review of their products.