Biocon Scores Japan Approval For New Cancer-Care Biosimilar

Cancer care is gaining another biosimilar option in Japan as Biocon Biologics secures marketing approval for its pegfilgrastim.

The approval gives Biocon a new entry in Japan’s oncology market and adds to its existing biosimilar portfolio in the country.

Biocon Biologics developed and manufactured the product as a biosimilar to Neulasta, a pegfilgrastim medicine used as supportive care following chemotherapy.

The product helps reduce the risk of infections associated with chemotherapy-induced neutropenia. Swiss giant Sandoz will exclusively promote, sell, and distribute the product in Japan, while Global Regulatory Partners Japan will serve as the marketing authorization holder.

Key Highlights

• Biocon Biologics received MHLW approval for its pegfilgrastim biosimilar in Japan.
• The product serves as a biosimilar to Neulasta and supports cancer care following chemotherapy.
• The approval expands Biocon’s biosimilar portfolio in Japan and strengthens its oncology offering.

Biocon Adds Pegfilgrastim to Japan Cancer-Care Portfolio

Biocon Biologics has developed and manufactured the newly approved pegfilgrastim biosimilar. The medicine provides supportive treatment for patients undergoing chemotherapy by reducing the risk of infection linked to chemotherapy-induced neutropenia. The product references Neulasta, which contains pegfilgrastim, and adds another oncology-focused medicine to Biocon’s biosimilar portfolio.

The Japanese approval also expands Biocon’s presence in cancer care through a product that targets supportive treatment rather than the cancer itself. Biocon already lists pegfilgrastim among its oncology biosimilars alongside trastuzumab and bevacizumab.

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Sandoz to Lead Commercial Launch in Japan

Biocon has chosen a partner-led commercialization model for the new cancer care product in Japan. Swiss giant Sandoz will hold exclusive rights to promote, sell, and distribute the pegfilgrastim biosimilar across the Japanese market. Global Regulatory Partners Japan will act as the Marketing Authorization Holder on behalf of Biocon.

Biocon and Sandoz already maintain a broader biosimilar partnership. The companies began their collaboration in 2018 to develop next-generation biosimilars for immunology and oncology. Biocon says the partnership combines its biosimilar R&D and manufacturing capabilities with Sandoz’s regulatory and commercial expertise in developed markets.

With the latest MHLW approval, Biocon now adds another product to its Japanese biosimilar portfolio. The company said the approval strengthens its presence in Japan and supports its commitment to improving access to high-quality, affordable medicines globally.