Abstract

Biosimilars, biologic drugs highly similar to approved reference products, are revolutionizing healthcare by offering cost-effective alternatives to biologics. This article explores current regulatory pathways and the concept of clinical equivalence in biosimilar development. Regulatory bodies like the FDA and EMA require rigorous analytical and clinical studies to ensure biosimilarity. Clinical equivalence, determined through pharmacokinetic and pharmacodynamic studies, establishes safety and efficacy akin to reference products. Challenges include biologic complexity and immunogenicity. Despite challenges, biosimilars promise substantial cost savings and expanded treatment access. Future trends include advancements in analytical techniques and market growth.