and are in clinical use for a number of diseases. Recently, the expiry of many of these product patents led to the\ndevelopment of other non-innovator similar biologics at lower costs, having the same safety, purity and potency as\ntheir original counterparts. These non-innovator similar biologics are generally referred to as biosimilars.\nBiosimilars are produced in living organisms by recombinant DNA techniques and exploiting the cellular\nmechanisms of the host so, there could be some differences at the molecular level due to their complex\nnature. Henceforth, they have to face numerous challenges for their development and approval, including the\ncomplex manufacturing process, immunogenicity issues, nomenclature, extrapolation of different indications,\ninterchangeability with their originators, awareness amongst the clinicians and patients and the costs of production\nfor the manufacturers.\n\n \n \n \n\n\n \n \n \n\n \n \n \nconcerns, indeed the standard generic approach is not applicable to demonstrate similarity between a biosimilar\nand its reference product. So, many Regulatory Authorities have established guidelines for the development and\napproval of biosimilars.\nBiosimilars are an essential product category that makes biological drugs available to different markets at an\naffordable cost. Their use is ought to increase in the upcoming years as per the demand and supply of these drugs is\nconcerned. Hence, aim of this review is to discuss the problems surrounding the biosimilars and to give an overview\non their regulatory statuses across the world. Concluding, we believe that to achieve a balance between drug quality,\nsafety and the population health needs, a profound knowledge of biosimilar development as well as joint effort of the\nmanufacturers and their will to share the critical development data, is needed.
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