ABSTRACT

Biosimilar drugs increase patient access while growing the biotherapeutic market. This Regulatory authorization, market accessibility, and clinical evaluations conducted before regulatory approval were examined about the landscape of biosimilar goods in Europe and the US. In the US, the approval procedure for biosimilars. Analytical and clinical data are heavily weighted in this procedure to ensure that biosimilars exhibit substantial resemblance to their reference products. The FDA adopts a strict methodology and demands comprehensive pre-clinical and clinical testing. The European Medicines Agency manages the unified process for approving biosimilars in the EU. The EMA emphasizes the use of all available evidence, including analytical, non-clinical, and clinical data. Due to the EU's experience with biosimilars, there is a healthy market with several medicines that have been approved. India, in contrast, has its own set of biosimilar regulations that are overseen by the CDSCO. India's method is distinguished by a significant emphasis on comparability and a step-by-step methodology that involves in-depth analytical investigations and constrained clinical trials. The regulatory framework in India seeks to strike a balance between affordability and effectiveness. On a case-by- case basis, careful consideration is required for highly complex comparable biologics of monoclonal antibodies. Keywords: Authorization, Approval, Biosimilar, FDA, EMA, CDSCO
Publication date: 01/11/2024

https://ijbpas.com/pdf/2024/November/MS_IJBPAS_2024_8452.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.11.8452