Biosimilars: A Critical Review of Development, Regulatory Landscape, and Clinical Implications

The biopharmaceutical industry has witnessed significant growth in the development and approval of biosimilars. These biosimilars aim to provide cost-effective alternatives to expensive originator biosimilars, alleviating financial pressures within healthcare. The manufacturing of biosimilars is a highly complex process that involves several stages, each of which must meet strict regulatory standards to ensure that the final product is highly similar to the reference biologic. To gain regulatory approval, biosimilars must undergo rigorous analytical characterization including in vitro assays, bioanalytical evaluations, and clinical similarity studies like pharmacokinetic (PK), pharmacodynamic (PD) assessments-to demonstrate safety, efficacy, quality comparability with reference products. Leading regulatory agencies such as the European Medicines Agency (EMA), the World Health Organization (WHO), and the United States Food and Drug Administration (US FDA) have established stringent guidelines for biosimilar evaluation and post-marketing surveillance. Despite this regulatory clarity, challenges around interchangeability, market exclusivity, and patent protection often delay market access and limit adoption, particularly in regions where automatic substitution is restricted. Case studies of biosimilars such as rituximab, adalimumab, filgrastim, and trastuzab reveal both advancements and ongoing hurdles in achieving broader market integration. The introduction of biosimilars has shown potential to reduce healthcare costs; for example, a recent analysis indicates a 20–30% cost reduction in the U.S. due to biosimilar adoption. As the biosimilar market expands, collaborative efforts among regulatory bodies, industry stakeholders, and healthcare providers are essential to enhance access to biologic therapies. This collaboration is poised to improve patient outcomes and catalyse transformative change in global healthcare systems.

Graphical Abstract