Biocon's Pegfilgrastim Biosimilar Gets Japan MHLW Nod, Sandoz to Exclusively Market Product
Bengaluru: Biocon Biologics Ltd., a wholly owned subsidiary of Biocon Ltd., has received marketing approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for its biosimilar version of pegfilgrastim, a medicine used to reduce the risk of infection caused by chemotherapy-induced neutropenia.
The approved product is a biosimilar to Neulasta® (pegfilgrastim) and has been developed and manufactured by Biocon Biologics.
Under the arrangement, Global Regulatory Partners Japan will serve as the Marketing Authorization Holder for the product in Japan on behalf of Biocon.
Sandoz K.K. will have exclusive rights to promote, sell, and distribute the pegfilgrastim biosimilar in the Japanese market.
The approval expands Biocon Biologics’ portfolio of biosimilar medicines in Japan and supports its strategy of improving access to affordable biologic therapies.
Pegfilgrastim is a long-acting granulocyte colony-stimulating factor (G-CSF) that helps stimulate the production of neutrophils, a type of white blood cell that plays an important role in fighting infections. It is commonly used to reduce the duration of chemotherapy-induced neutropenia and the incidence of febrile neutropenia in eligible cancer patients.
The product joins Biocon Biologics’ growing portfolio of biosimilars and other biologic therapies available across global markets.
The company said the Japan approval reinforces its commitment to expanding patient access to high-quality and affordable medicines.
Biocon Biologics has been expanding its presence in the global biosimilars market, with products spanning areas including oncology, diabetes, immunology and ophthalmology.
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