Biocon Biologics has received Marketing Approval (MA) for its pegfilgrastim biosimilar from Japan’s Ministry of Health, Labour and Welfare (MHLW). The product, a biosimilar to Neulasta, is developed and manufactured by Biocon Biologics, parent entity of Biocon Biologics UK PLC, with Global Regulatory Partners Japan serving as the MA Holder on behalf of Biocon.

Sandoz KK shall exclusively promote, sell, and distribute the product in Japan.

This approval further strengthens Biocon’s portfolio of biosimilar products in Japan and reaffirms the company’s commitment to increasing patient access to high-quality and affordable medications globally.

Neulasta is a registered trademark of Amgen Inc.