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FDA accepts Mylan's BLA for proposed biosimilar Pegfilgrastim

Press Trust of India  |  New Delhi 

US health regulator USFDA has accepted pharma major Mylan's biologics licence application (BLA) for MYL-1401H, a proposed biosimilar Pegfilgrastim, and Mylan have said.

The proposed biosimilar Pegfilgrastim is one of the six biologic products co-developed by Mylan and 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 partnership within the past two months."

The milestone builds on the acceptance of regulatory filings for proposed biosimilar Pegfilgrastim in Europe, 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 and Mylan is an outcome of our strong R&D and manufacturing capabilities," CEO and Joint MD Arun Chandavarkar said.

Once approved, the proposed biosimilar Pegfilgrastim will provide a high quality alternative to branded Pegfilgrastim (Neulasta) for 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.

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

The stock of was today trading at Rs 1,106.90 in the afternoon trade on BSE, up 1.12 per cent from its previous close.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Fri, February 17 2017. 14:48 IST