EMA Accepts MAA For Mylan’s Biosimilar of Amgen’s Neulasta

The European Medicines Agency (EMA) has accepted for review Mylan’s marketing authorization application (MAA) for its proposed biosimilar of pegfilgrastim, the active ingredient in Amgen’s Neulasta. Neulasta is one of Amgen’s top-selling drugs with 2015 revenues of $4.7 billion.

Pegfilgrastim is prescribed for cancer patients to help them with some of the side-effects of their treatment. It reduces the duration of neutropenia (low levels of neutrophils, a type of white blood cell that fights infections) and the incidence of febrile neutropenia (neutropenia with fever) that are a result of their chemotherapy treatment.).

Mylan has co-developed the proposed biosimilar with Biocon, an Indian biopharmaceutical company. Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and generic insulin analogs. The proposed biosimilar pegfilgrastim is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the proposed biosimilar pegfilgrastim in the US Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

Earlier this month, Sandoz, a division of Novartis, reported that the US Food and Drug Administration had issued a Completer Response Letter regarding its application for a biosimilar pegfilgrastim,. The company said that “we are working with the agency to address remaining questions.” FDA had accepted for review Sandoz’s application for a biosimilar pegfilgrastim in November 2015. 

Source: Mylan and Novartis

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