Biosimilar development and review process in the BRICS-TM countries: Proposal for a standardized model to improve regulatory performance.

Effective implementation of the proposed standardized model for biosimilar development and approval processes across the BRICS-TM agencies will eliminate unwarranted studies, reduce the development costs, and enhance process efficiency thereby expediting patients' access to new affordable biosimilar medicines.Plain language summaryThe studies presented in this article have identified key areas for improvement in biosimilar development and approval pathways in BRICS-TM countries, which have formed the basis for development of a model to standardize requirements for biosimilar development and the approval process, with a view to improve regulatory performance. Implementation of the proposed model by the BRICS-TM regulatory agencies with consideration of a stepwise approach and science-based evaluation of analytical data could reduce the duplication and unnecessary conduct of non-clinical studies, thereby reducing the development cost and review timelines. Data assessment based on reliance as considered in the proposed model would strengthen reliance networks and improve the process efficiency among the BRICS-TM regulatory agencies. Flexibility in regulatory requirements by the BRICS-TM agencies for the use of Reference Biologic Product (RBP) from other emerging economies and their interaction with the developers would enhance transparency and ease the challenges in sourcing RBP from different jurisdictions. This would further help in expediting a common biosimilar development process. Good Manufacturing Practice (GMP) inspection of the biosimilar manufacturing facilities by desktop audit or off-site audit and acceptance of GMP certifications from other reference agencies would improve the overall regulatory performance and reduce overall review timelines, leading to faster availability of biosimilar medicines for patient access.