Biocon closer to Europe approval of biosimilar pegfilgrastim

The CHMP opinion will now be considered by the European Commission for approval.

The decision on approval is expected by November 2018, the company said.

“Data submitted as part of the Marketing Authorization Application included similarity assessment in analytical testing, preclinical and clinical studies that demonstrated biosimilarity to the reference product, Neulasta,” Biocon said.

Fulphila was approved by US FDA earlier this year and is the first USFDA approved biosimilar for Neulasta in the US.

Regulatory applications for Fulphila also have been submitted in Australia, New Zealand, Canada and several other countries.

"CHMP's decision to recommend approval of Biocon and Mylan's biosimilar Pegfilgrastim brings us a step closer to offer this high quality, affordable biologic therapy for cancer patients in the EU, having launched this product in the US, earlier this year,” said Biocon CEO and Joint Managing Director Arun Chandavarkar.

Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products.

Neulasta is one of 11 biologic and insulin products co-developed by Mylan and Biocon for the global marketplace.

Mylan has exclusive commercialization rights for the product in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialisation rights with Mylan for the product in the rest of the world.

While Biocon develops and manufactures the drug, Mylan takes care of regulatory approvals and marketing.