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54
4 进行中
药物批准
0
批准总数
监管机构
监管机构数
成立时间
1961
进行中（未招募）
4
7.4%
已完成
46
85.2%
招募中
2
3.7%
终止
暂无批准数据
- 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.
