Biosimilars can be broadly defined as those medicines produced using a living system or genetically modified organism. They are different from conventional generics in many ways, in size, structure, stability, heterogeneity, and analytical characterization. Biosimilars are not true generics, but exhibit a high degree of similarity to the reference biologic. Biosimilars are biotechnological generated products and copy of original products in term of pharmacological effect with the difference in structure or process of manufacturing. Along with the difference, the biosimilar should be comparable to the innovator drug in safety, efficacy, and quality as demonstrated by analytical, preclinical, and clinical trials. Present review focused the biosimilar market of India in contrast with current challenges to face by Indian biosimilar manufacturer. This article will provide an overview of biosimilars discussing the differences between biosimilars and chemical generics, the scientific and regulatory challenges and concerns with the use of biosimilars.
Impact Factor
2022: 6.012
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