Albert Wai-Kit Chan Intellectual Property Limited, Hong Kong, SAR, China.
Touro College of Pharmacy, New York, USA.
BioDrugs. 2017 Jun;31(3):189-205. doi: 10.1007/s40259-017-0216-7.
Many first-generation biologics will lose their patent protection by 2020. The biosimilars market is not only attractive but also competitive and tough. The United States (US) is the world's largest pharmaceutical market and is critical to the success of most drugs. However, unclear regulatory requirements and confusing patent resolution procedures create hurdles to market entry of biosimilars. Trade secret exposure and scant exclusivity and adoption also limit the market access of biosimilars. Both biologics and biosimilar developers should closely follow the regulatory and litigation landscape to successfully navigate through the challenges. Focusing on the US landscape, this article provides a brief review of the regulatory framework for biosimilar products, market exclusivities, and patent issues under the Biologics Price Control and Innovation Act (BPCIA), analyzes emerging issues in the biosimilar litigation landscape, and provides recommendations for companies entering the biosimilars market.
许多第一代生物制剂将在 2020 年前失去专利保护。生物类似药市场不仅具有吸引力，而且竞争激烈。美国是全球最大的药品市场，对大多数药物的成功至关重要。然而，监管要求不明确以及专利解决方案程序混乱，为生物类似药的市场准入制造了障碍。商业秘密披露以及专有权和采用率低也限制了生物类似药的市场准入。生物制剂和生物类似药开发商都应密切关注监管和诉讼动态，以成功应对挑战。本文聚焦于美国市场，简要回顾了《生物制品价格竞争与创新法案》（BPCIA）下生物类似药产品的监管框架、市场专有权以及专利问题，分析了生物类似药诉讼领域的新问题，并为进军生物类似药市场的公司提供了建议。
