Japan approves Biocon Biologics’ pegfilgrastim biosimilar for cancer supportive care

The MHLW marketing approval adds a Neulasta biosimilar to Biocon’s Japanese portfolio, with Sandoz K.K. responsible for its exclusive promotion, sale and distribution in the country.

Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted marketing approval to Biocon Biologics’ pegfilgrastim biosimilar to Neulasta, expanding the company’s biosimilar portfolio in the Japanese market.

The product was developed and manufactured by Biocon Biologics, with Global Regulatory Partners Japan serving as marketing authorisation holder and Sandoz K.K. exclusively responsible for promotion, sales and distribution in Japan.

Field	Content
Alert Type	Drug Approval
Drug Name	Pegfilgrastim biosimilar to Neulasta
Indication	Pegfilgrastim is used as supportive treatment to reduce the risk of infection associated with chemotherapy-induced neutropenia. (Business Standard)
Therapy Area(s)	Oncology; Haematology; Cancer supportive care
Geography	Japan
What Happened	On 25 August 2026, Biocon announced that wholly owned subsidiary Biocon Biologics had received marketing approval from Japan’s MHLW for its pegfilgrastim biosimilar to Amgen’s Neulasta. The product was developed and manufactured by Biocon Biologics. Global Regulatory Partners Japan serves as the marketing authorisation holder on Biocon’s behalf, while Sandoz K.K. will exclusively promote, sell and distribute the product in Japan. (Business Standard)
Why It Matters	The approval expands the availability of biosimilar pegfilgrastim within Japan and strengthens Biocon’s presence in the country’s biosimilars market. For Biocon, it adds another approved oncology-supportive-care biosimilar to a global portfolio in which pegfilgrastim is already established; its Fulphila pegfilgrastim biosimilar had reached a 30% US market share by the end of FY2025. (Biocon Biologics)
Supporting Context	Pegfilgrastim is a long-acting granulocyte colony-stimulating factor used to reduce the incidence of infection associated with chemotherapy-induced neutropenia. Biocon Biologics has an established global pegfilgrastim franchise and was the first company globally to receive US FDA approval for a biosimilar pegfilgrastim in 2018. (Biocon Biologics)
Key Takeaway	Japanese marketing approval expands Biocon Biologics’ biosimilar footprint while giving Sandoz K.K. an additional oncology supportive-care product to commercialise in the country.
What to Watch	Commercial launch timing and how Sandoz positions the product within Japan’s existing pegfilgrastim market will determine the near-term commercial impact of the approval.
Primary Source	Biocon / Biocon Biologics regulatory announcement
Relevant Date	25 August 2026

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