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USV’s Juta Gets An EU Pegfilgrastim Nod

Executive Summary

Juta Pharma has received a positive opinion from the European Medicines Agency’s CHMP recommending granting a pan-European marketing authorization for its biosimilar pegfilgrastim, Grasustek.

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As Stada and Gedeon Richter withdraw their applications for a pegfilgrastim biosimilar that the pair have been jointly developing, Mundipharma has pushed ahead with a European roll-out for its Pelmeg version starting in Germany, Ireland and the Netherlands.

Three firms in EU get nods on pegfilgrastim

Three firms – Mundipharma, Mylan and Sandoz – have received final pan-European marketing authorisations from the European Commission for biosimilar rivals toAmgen’s Neulasta (pegfilgrastim). The nods for Mundipharma’s Pelmeg, Mylan’s Fulphila and Sandoz’ Ziextenzo followed positive recommendations from the European Medicines Agency’s (EMA’s) committee for human medicinal products (CHMP) towards the end of September (Generics bulletin, 28 September 2018, page 15).

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