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Ashwati V. Nair*, Purnima D. Hamrapurkar and Rajani B. Athawale 


Giving birth to a child is every human‟s desire and nowadays the rate of infertility is increasing due to many factors. Therefore there are various advances in the medical field to treat infertile women; one amongst them is by using biologics and biosimilars. The recombinant human follicle-stimulating hormone (r-hFSH); a biotechnologically derived hormone developed as an original biological molecule, is proven to be advantageous in the induction of ovulation, and thus formulated as biosimilars. Biosimilars are proven to be similar to original biologics in terms of structure, safety, efficacy, biological activity, and immunogenicity. The ultimate aim of the manufacturing and the entire developmental steps of biosimilar products focuses to match its profile with the original biologic and to accomplish this aim various comparability testings are carried out like physicochemical and functional groups, non-clinical, clinical, and confirmatory. Thus increasing another treatment option to the infertile female population to attain fertility.

Keywords: Infertility, Biosimilars, recombinant human follicle-stimulating hormone, manufacture, developmental steps.

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