Viswanath PillaMoneycontrol News
Biopharmaceutical firm Biocon and its partner Mylan on September 21 said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Filphila or pegfilgrastim.
Pegfilgrastim is a biosimilar version of Amgen’s Neulasta used to stimulate the level of neutrophils, a type of white blood cell that gets damaged in cancer patients undergoing chemotherapy.
The CHMP recommendation takes Biocon a step closer towards the approval of biosimilar pegfilgrastim in Europe.
Amgen's Neulasta had brand sales of more than $450 million in Europe for the 12 months ending June 30, 2018, according to market research firm IQVIA.
“The CHMP positive opinion is based upon a review of evidence demonstrating biosimilarity,” Biocon said in a statement.
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.