Pharmacy News

Lupin announces USFDA acceptance for a biosimilar application, Health News, ET HealthWorld

Drug maker Lupin on Wednesday said the US health regulator has accepted its application for a biosimilar product which is used to treat cancer patients. The US Food and Drug Administration (USFDA) has accepted the Biologics License Application (BLA) for its proposed biosimilar to Neulasta (pegfilgrastim) through a filing, the Mumbai-based drug maker said in a statement.

As per IQVIA MAT December 2020 data, Pegfilgrastim has estimated annual sales of USD 3.66 billion in the US.
Pegfilgrastim is used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy.

“FDA’s acceptance of our BLA is a significant achievement and demonstrates our commitment to delivering products which increase access in areas of substantial medical need. This BLA expands our oncology portfolio, an area of increasing focus for Lupin. We look forward to the opportunity to bring affordable biologic options to patients and increasing access to this important treatment,” Lupin CEO Vinita Gupta said.

The pegfilgrastim filing is the company’s first biosimilar filing in the US and is a milestone in the drug maker’s research and innovation journey, Lupin MD Nilesh Gupta noted.

“Biosimilars is a key part of our growth strategy and we are proud of the world-class achievements of our group,” he added.

Shares of the company were trading 2.68 per cent up at Rs 1,41.05 apiece on the BSE.

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