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

Abstract

Introduction: Biosimilars promote price competition, improving affordability and access to biologics without compromising on quality, efficacy, and safety. Biosimilar approvals initially followed a cautious approach, with regulatory requirements developed independently across jurisdictions, complicating global development and increasing costs. Advancements in analytical sciences and two decades of accumulated experience with biosimilar approvals offer an opportunity to reevaluate regulatory requirements.

Areas covered: A structured literature review was conducted using PubMed, Embase, and Web of Science, to identify challenges related to biosimilarity demonstration, offer a comprehensive understanding of regulatory requirements for biosimilars globally, and identify opportunities for regulatory convergence. Following title, abstract and full-text screening, 61 articles were included.

Expert opinion: 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.