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Amar Ashruba Kaware*, Chavan Geetanjali C., Kareppa M. S., Raut D. J., Jaiswal N. R. and Syed I. J.


Biosimilars drugs having the fastest growth in the pharma sector. The other branded product and small molecule drugs are in the market in competition with each other, the biosimilars also have some effect in the market. Although the biosimilars are unknown for the people, it is effective and safe for the people in the cheaper price, which is comfortable to the people. Biosimilars are used for the treatment of life-threatening and rare diseases. The biosimilars are products that are based on the original product patent expiration, after the expiration of the original reference product the biosimilars can manufacture with the licensing of the original product. The process of chemically synthesis of the drug is more complex, so the recombinant DNA technology is introduced in the market, the biosimilars are made by the recombinant DNA technology. The biosimilars are "similar to the reference product but not the same to it. It has no clinical difference compared with the reference product. We have the aim to simplify the term Biosimilars, its history, definition, and manufacturing process, along with the approval of it.

Keywords: ?Biosimilars?, ?Manufacturing", ?Approval?, ?Pharmacovigilance.

[Full Text Article]

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