Centre for Pharmaceutical Nanotechnology, Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Sector 67, S.A.S, Nagar, Punjab, 160062, India.
Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS, 38677, USA.
Chem Biol Interact. 2022 Oct 1;366:110116. doi: 10.1016/j.cbi.2022.110116. Epub 2022 Aug 23.
Many biologic drug products, particularly monoclonal antibodies (mAbs), were off-patented between 2015 and 2020, and this process is continuing as the number of biologics approvals has increased. However, the availability of affordable biosimilars is delayed by secondary patents related to the formulation and manufacturing process. Therefore, an alternative formulation development is required to avoid infringement of formulation related patents. Several variables must be considered while developing alternative non-infringement formulations, including the time gap between the expiration of the molecule patent and the formulation patent, the ability not to infringe other secondary patents (process-related), and project timelines. As a part of life cycle management, innovator companies are adopting multiple strategies to delay biosimilar competition. Biosimilar companies could use the innovator formulation knowledge space to develop alternative formulations at the expense of time and cost. The present review discusses the key approaches in biosimilar formulation development, and further summarizes the use of innovator formulation knowledge space for biosimilar mAbs product development.
许多生物药物产品，特别是单克隆抗体（mAbs），在 2015 年至 2020 年期间已过专利保护期，随着生物制品批准数量的增加，这一过程仍在继续。然而，由于与制剂和制造工艺相关的次要专利的存在，廉价生物类似药的供应仍被延迟。因此，需要开发替代的制剂来避免侵犯制剂相关专利。在开发替代的非侵权制剂时，必须考虑到几个变量，包括分子专利和制剂专利到期之间的时间差、不侵犯其他次要专利（与工艺相关）的能力，以及项目时间表。作为生命周期管理的一部分，创新型公司正在采取多种策略来延迟生物类似药的竞争。生物类似药公司可以利用创新者的制剂知识空间来开发替代制剂，代价是时间和成本。本文讨论了生物类似药制剂开发的关键方法，并进一步总结了利用创新者制剂知识空间开发生物类似药 mAbs 产品。
