First Biosimilar Neulasta In Final Stages Of EMA Review Process
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.
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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.
USV has joined the list of firms seeking clearance for biosimilar pegfilgrastim in Europe. Managing director Prashant Tewari says the company is “well geared” to address potential price competition and maintains that biosimilarity of USV’s pegfilgrastim with the innovator product has been established “satisfactorily”.
The EMA’s scientific committee, the CHMP, has given the green light to new treatments for multiple sclerosis, eosinophilic esophagitis, CMV, hemophilia A, and vaginal atrophy, as well as the EU’s first biosimilar version of Roche’s Avastin. The committee upheld two earlier negative opinions, and two products have been withdrawn from the assessment process.