Biosimilars and Future Biotherapeutics

Regulatory Pathways and Global Harmonization

Regulatory Pathways and Global Harmonization evolving regulatory frameworks that govern the approval and oversight of biosimilars across different regions, and the growing need for global alignment to support broader patient access and industry innovation. Biosimilar development is uniquely complex due to the intricate nature of biologic medicines, and regulatory agencies have developed specialized pathways to ensure these products meet rigorous standards for quality, safety, efficacy, and biosimilarity to their reference products. Key topics will include comparative overviews of regulatory pathways established by major agencies such as the U.S. FDA, European Medicines Agency (EMA), World Health Organization (WHO), Japan’s PMDA, and regulatory bodies in emerging markets. As the global biosimilar market expands, the call for harmonization and convergence of regulatory standards is becoming stronger. reduce duplication in clinical trials, and facilitate mutual recognition agreements, which can ultimately lead to faster approvals and reduced development costs.