ABSTRACT

Biosimilars are biological products that are highly similar to already approved reference biological products in terms of quality, safety, and efficacy. They have become an increasingly important segment of the pharmaceutical industry due to their potential for increasing access to safe and effective biological therapies, reducing healthcare costs, and fostering innovation. The development of biosimilars requires a rigorous process to ensure that they are equivalent to the reference product in terms of safety and efficacy. In this review, we provide an overview of the current regulatory framework for biosimilars, including the guidelines for approval and post-approval monitoring. We also discuss the challenges associated with developing and manufacturing biosimilars, as well as the potential benefits and limitations of these products. Finally, we provide an update on the current status of biosimilars in various therapeutic areas and discuss the future outlook for biosimilar development and use. Overall, biosimilars have the potential to significantly impact the healthcare landscape and provide new treatment options for patients, but continued research and development are needed to optimize their safety and efficacy. Keywords: Biosimilar; Biologic; Interchangeability; in-vivo; pharmacology
Publication date: 15/06/2023

https://ijbpas.com/pdf/2023/June/MS_IJBPAS_2023_JUNE_SPCL_1041.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.6.1041