FDA Accepts Mylan’s Filing for Neulasta BiosimilarBy
The US Food and Drug Administration (FDA) has accepted a biologics license application from Mylan and its partner, Biocon, a Bangalore, India-headquartered biopharmaceuticals company, for a proposed biosimilar to Amgen’s Neulasta (pegfilgrastim), a leukocyte factor for treating neutropenia, or low white blood cell count, in patients with certain types of non-myeloid cancers. Neulasta is one of Amgen’s top-selling drugs with $3.9 billion in 2016 sales.
Mylan and Biocon’s proposed biosimilar to Neulasta is used to reduce the duration of neutropenia and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer. The FDA has set a goal date in October 2017 under the Biosimilar User Fee Act.
Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and generic insulin analogs. The proposed biosimilar to pegfilgrastim, the active ingredient in Neulasta, is one of the six biologic products co-developed by Mylan and Biocon for the global market. 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.