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Clinical Trials
54
4 active
Approvals
0
Total approvals
Agencies
Regulatory bodies
Founded
1961
Active, not recruiting
4
7.4%
Completed
46
85.2%
Recruiting
2
3.7%
Terminated
No approval data available
- Biocon has received marketing approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for its pegfilgrastim biosimilar, confirmed on August 25, 2026. - The product, developed and manufactured by wholly-owned subsidiary Biocon Biologics Ltd., serves as a biosimilar to Neulasta®, a registered trademark of Amgen Inc. - Sandoz K.K. will exclusively promote, sell, and distribute the pegfilgrastim biosimilar in Japan, with Global Regulatory Partners Japan acting as Marketing Authorization Holder. - The approval strengthens Biocon's biosimilar portfolio in one of Asia's largest pharmaceutical markets and reaffirms its commitment to increasing patient access to affordable medications.