作者|Bio-three安进生物类似药研发策略(2026 JPM会议资料)值得注意的是,随着FDA和EMA在2025年相继表示,支持生物类似药申报所需的III期临床试验必要性转变的契机下,也催化了国内生物类似药的研发热潮。在当前创新药高举高打的热潮下,生物类似药似乎在角落中再次萌芽,迎来了新的生机。粗略检索CDE受理品种信息,国内生物药3.3类生物类似药申报数量达到了26项,自2025年以来增速...
Source Link作者|Bio-three安进生物类似药研发策略(2026 JPM会议资料)值得注意的是,随着FDA和EMA在2025年相继表示,支持生物类似药申报所需的III期临床试验必要性转变的契机下,也催化了国内生物类似药的研发热潮。在当前创新药高举高打的热潮下,生物类似药似乎在角落中再次萌芽,迎来了新的生机。粗略检索CDE受理品种信息,国内生物药3.3类生物类似药申报数量达到了26项,自2025年以来增速...
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