Biocon Pegfilgrastim Biosimilar Wins Japan Marketing Approval
Biocon has secured marketing approval for its pegfilgrastim biosimilar from Japan's Ministry of Health, Labour and Welfare (MHLW). The approval was confirmed on August 25, 2026.
The product is developed by Biocon Biologics Ltd. and serves as a biosimilar to Amgen's Neulasta.
Sandoz K.K. will exclusively promote, sell, and distribute the drug in Japan, allowing Biocon to leverage local distribution networks while focusing on manufacturing and regulatory compliance.