17^th European Biosimilars Congress

Current Agency Expectations for Approval for Biosimilars

Current agency expectations for the approval of biosimilars focus on demonstrating a high level of similarity to the reference biologic in terms of quality, safety, and efficacy. Regulatory authorities, such as the FDA and EMA, require comprehensive analytical and preclinical data to establish a robust scientific foundation for biosimilarity. This includes extensive physicochemical and biological characterization, comparative pharmacokinetic and pharmacodynamic studies, and non-clinical toxicity assessments. Clinical trials are also conducted to demonstrate similar clinical efficacy and safety profiles. In addition to comparative data, agencies emphasize the importance of a thorough risk management plan and post-marketing surveillance to ensure ongoing safety monitoring. By meeting these agency expectations, biosimilar manufacturers can obtain regulatory approval and provide patients with cost-effective alternatives to reference biologics while maintaining high standards of quality and safety.