Biocon's Pegfilgrastim Biosimilar Gets Japan MHLW Approval

Biocon Biologics Ltd., a subsidiary of Biocon Ltd., has received marketing approval for its pegfilgrastim biosimilar from Japan's Ministry of Health, Labour and Welfare (MHLW). The biosimilar, a substitute for Neulasta®, was developed and manufactured by Biocon Biologics. Global Regulatory Partners Japan will act as the Marketing Authorization Holder, while Sandoz K.K. will exclusively promote, sell, and distribute the product in Japan. This approval expands Biocon's biosimilar offerings in Japan and underscores its commitment to global patient access to affordable medications.