NEW DELHI: US health regulator USFDA has accepted pharma major Mylan’s biologics licence application (BLA) for MYL-1401H, a proposed biosimilar Pegfilgrastim, Biocon and Mylan have said.
The proposed biosimilar Pegfilgrastim is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace, the two companies said in a statement.
Mylan President Rajiv Malik said: “This is the second BLA accepted for review by FDA as part of the Mylan and Biocon partnership within the past two months.”
The milestone builds on the acceptance of regulatory filings for proposed biosimilar Pegfilgrastim in Europe, Australia and Canada, he added.
“Once approved, proposed biosimilar Pegfilgrastim will complement Mylan’s broad oncology portfolio focused on expanding access to more affordable treatments for multiple types of cancer,” Malik said.
The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is October 9, 2017, the statement said.
“The FDA’s acceptance for review of our second BLA for a proposed biosimilar developed by Biocon and Mylan is an outcome of our strong R&D and manufacturing capabilities,” Biocon CEO and Joint MD Arun Chandavarkar said.
Once approved, the proposed biosimilar Pegfilgrastim will provide a high quality alternative to branded Pegfilgrastim (Neulasta) for cancer patients during cytotoxic chemotherapy, he added.
Mylan has exclusive commercialisation 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, the statement said.
Biocon has co-exclusive commercialisation rights with Mylan for the product in the rest of the world, it added.
The 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 stock of Biocon was today trading at Rs 1,106.90 in the afternoon trade on BSE, up 1.12 per cent from its previous close.