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Biocon Announces Pegfilgrastim Biosimilar Marketing Approval by Japan Ministry of Health, Labour and Welfare (MHLW)

  • Tue, 25-Aug-2026
  • Posted by: BIOCON
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NOTIFICATION TO STOCK EXCHANGE

COMPANY STATEMENT

Bengaluru, Karnataka, India, August 25, 2026

Biocon Biologics Ltd., a wholly-owned subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), received marketing approval for its pegfilgrastim biosimilar (“Product”) from Japan’s Ministry of Health, Labour and Welfare (MHLW). The product, a biosimilar to Neulasta®, is developed and manufactured by Biocon Biologics Ltd, parent entity of Biocon Biologics UK PLC (Biocon Biologics Ltd and Biocon Biologics UK PLC shall be collectively referred to as “Biocon”), with Global Regulatory Partners Japan serving as the Marketing Authorization Holder on behalf of Biocon. Sandoz K.K. 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.

– Company Spokesperson

Neulasta® is a registered trademark of Amgen Inc.


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Author: BIOCON

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