Evolving global regulatory landscape for approval of biosimilars: current challenges and opportunities for convergence

Biosimilar guidelines from stringent regulatory authorities such as EMA and USFDA are robust, yet further alignment of regulatory standards in the US and EU is possible to reflect scientific progress and clinical experience. Regulatory requirements for biosimilars in emerging markets appear to be disproportionate to scientific advancements and accumulated knowledge with biosimilars approval and clinical experience. Global harmonization of biosimilar guidelines, based on gained developments and regulatory experience, could accelerate development and approval process. This would facilitate earlier and enhanced access to safe and affordable biologics.