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Nishith Desai Associates:2026生物制剂革命:驾驭生物类似药、BPCIA 与专利舞蹈的全球格局报告(中译版)(82页).pdf

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1、 Nishith Desai Associates MUMBAI SILICON VALLEY BENGALURU SINGAPORE NEW DELHI NEW YORK GIFT CITY BOSTONResearchThe Biologics RevolutionNavigating the Global Landscape of Biosimilars,BPCIA,and the Patent Dance February 2026 Nishith Desai Associates ResearchThe Biologics RevolutionNavigating the Globa

2、l Landscape of Biosimilars,BPCIA,and the Patent DanceFebruary 2026 Nishith Desai Associates Ranked as the Most Innovative Indian Law Firm in the prestigious FT Innovative Lawyers Asia Pacific Awards for multiple years.Also ranked amongst the Most Innovative Asia Pacific Law Firm in these elite Finan

3、cial Times Innovation rankings.The Biologics Revolution Navigating the Global Landscape of Biosimilars,BPCIA,and the Patent Dance Nishith Desai Associates 2026Provided upon request only DisclaimerThis report is a copyright of Nishith Desai Associates.No reader should act on the basis of any statemen

4、t contained herein without seeking professional advice.The authors and the firm expressly disclaim all and any liability to any person who has read this report,or otherwise,in respect of anything,and of consequences of anything done,or omitted to be done by any such person in reliance upon the conte

5、nts of this report.ContactFor any help or assistance please email us on or visit us at .Authors:IPpro TeamPriyadarsini Shanmugam Priya leads IPpros Lifesciences domain with 17 years of IP experience.She is a registered Attorney in California,US.She holds a biotechnology degree and masters in law fro

6、m UC Berkeley School of Law.She has extensive experience with patent firms,multinational companies,and global pharmaceutical in-house IP teams.Abhay Porwal Abhay leads overall operations at IPpro with over 20 years of IP industry experience.He is a registered patent agent with the IPO and holds a de

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1. **生物药与生物类似药市场转型**:全球生物药占医药收入42%(2023年),预计2027年将超小分子药;生物类似药通过竞争提升可及性,但美国 uptake 不均,因专利壁垒延迟上市。 2. **全球监管框架差异**:欧盟为标杆,美国 FDA 首创“可互换性”允许药房 substitution;印度、中国等要求本地参照品,增加开发成本。 3. **专利丛林策略**:原研企业通过剂型、工艺等专利延长市场独占期(如 Humira 在美70+专利 vs. 欧8项),导致美国生物类似药上市比欧洲晚近10年。 4. **BPCIA 诉讼机制**:美国“专利舞步”程序影响上市时间,生物类似药商通过诉讼、风险 launch 或和解进入市场,但高成本致仅10%生物药有类似药在研。 5. **未来挑战**:监管趋科学(如 FDA 拟减免单抗临床研究),但需平衡创新与可及性,战略联盟与地域 carve-out 成关键应对策略。
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