Date: August 25, 2026
Product Approval Disclosure
Biocon Biologics Ltd., a wholly-owned subsidiary of Biocon Ltd., received marketing approval for its pegfilgrastim biosimilar product from Japan's Ministry of Health, Labour and Welfare (MHLW).
The product is a biosimilar to Neulasta® (a registered trademark of Amgen Inc.).
Manufacturing and Development
The product was developed and manufactured by Biocon Biologics Ltd., which is the parent entity of Biocon Biologics UK PLC.
Commercial Arrangements
Global Regulatory Partners Japan will serve as the Marketing Authorization Holder on behalf of Biocon.
Sandoz K.K. shall exclusively promote, sell, and distribute the Product in Japan.
Strategic Impact
The approval strengthens Biocon's portfolio of biosimilar products in Japan.
The approval reaffirms the company's commitment to increasing patient access to high-quality and affordable medications globally.