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 pegfilgrastim biosimilar, strengthening the company’s biosimilars portfolio in the Japanese market.
The product is a biosimilar to Neulasta, a pegfilgrastim-based medicine used to reduce the risk of infection associated with chemotherapy-induced neutropenia. The product has been developed and manufactured by Biocon Biologics.
Global Regulatory Partners Japan will serve as the marketing authorisation holder on behalf of Biocon, while Sandoz K.K. will have exclusive responsibility for promoting, selling and distributing the product in Japan.
Expanding Japan biosimilars portfolio
The approval marks another step in Biocon Biologics’ efforts to expand access to high-quality and affordable biologic medicines in global markets.
Japan is an important market for biosimilars, with increasing focus on improving the affordability and accessibility of advanced therapies. The approval enables Biocon to further strengthen its presence in the country’s biologics market through its partnership with Sandoz.
The company said the regulatory clearance reinforces its commitment to increasing patient access to high-quality and affordable medicines globally.
The latest approval adds to Biocon Biologics’ growing portfolio of biosimilar products and strengthens its position in the global biosimilars industry.