ABSTRACT

Biosimilars are quickly becoming indispensable substitutes for biological medications made by original manufacturers, especially when treating serious and uncommon illnesses. The development of biosimilars is anticipated to pick up speed in the upcoming ten years as the patents for many biological medications are about to expire This paper analyzes the biosimilar product regulatory environment in the US and key emerging markets (BRICs-TM). The U.S. Food and Drug Administration (FDA) is a principal operator in facilitating the advancement of biosimilars by expediting the regulatory approval processes, as per the Biologics Price Competition and Innovation Act (BPCI). The FDA's strategy highlights the value of comparability to reference products and integrates quality-by-design principles without demanding precise replication. The biosimilar market is expanding quickly on a global scale; estimates suggest that sales could double to $15 billion by the early 2020s. While developed markets such as the United States and Europe have well-established regulatory frameworks, emerging economies present a combination of opportunities and challenges. These markets, which account for 70% of the world's population and a sizeable amount of pharmaceutical spending, provide an ideal environment for the development of biosimilars because of low biologic prevalence and cost limitations. However, there are a lot of challenges due to differences in regulations in emerging markets. These consist of discrepancies in the protocols for approval, the choice of reference products, the needs for clinical trials, and interchangeability guidelines. Regional variations in healthcare goals, policies, and financing mean that substantial gaps persist in emerging economies evenwith the efforts of major regulatory bodies to establish standardized approval processes. Addressing these legal obstacles is essential to advancing the production of biosimilars in emerging markets. The study highlights the need for harmonized regulatory approaches, particularly in areas where the products may have the biggest impact on patient care and healthcare economics, in order to fully realize the promise of biosimilars in improving access to and affordability of healthcare globally. Keywords: Biosimilar, USFDA, Emerging Markets-BRICs-TM, Regulatory requirement, Approval process
Publication date: 01/11/2025

https://ijbpas.com/pdf/2025/November/MS_IJBPAS_2025_9593.pdf

Download PDF
https://doi.org/10.31032/IJBPAS/2025/14.11.9593