Biosimilar monoclonal antibodies: Challenges and approaches towards formulation

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.