Lupin Receives Marketing Approval for Pegfilgrastim Biosimilar in India
核心洞察
Lupin has secured approval to manufacture and market its pegfilgrastim biosimilar in India, with production planned at its Nagpur facility in Maharashtra.
Pegfilgrastim is an onco-supportive therapy that helps the body produce neutrophils after chemotherapy to reduce the risk of serious infections and fever.
Lupin's Armlupeg (搜索) is already approved in the US, where commercial rights are out-licensed to Valorum Biologics (搜索), while Biocon and Amneal also market US pegfilgrastim biosimilars.
Lupin has received approval to manufacture and market its biosimilar version of pegfilgrastim in India. The Mumbai-based drugmaker will produce the onco-supportive therapy at its facility in Nagpur, Maharashtra.
Pegfilgrastim is designed to prevent chemotherapy-induced neutropenia (搜索), a loss of infection-fighting white blood cells. It helps the body produce neutrophils after chemotherapy, lowering the risk of serious infections and fever.
Lupin's formulation, branded Armlupeg (搜索), is already approved in the US, where the company has out-licensed commercial rights to biosimilar specialist Valorum Biologics (搜索). Among domestic peers, Biocon and Amneal also market a pegfilgrastim biosimilar in the US, while Aurobindo Pharma is at the development stage. Zydus Lifesciences recently acquired a novel alternative through its $166-million takeover of US-based Assertio Holdings (搜索). Innovator brand Neulasta peaked at more than $5 billion in sales before falling to around $435 million last year amid rising competition. Lupin did not respond to ETPharma's requests for comment.