Abstract: Biopharmaceuticals have been defined as “pharmaceuticals inherently biological in nature and manufactured using biotechnology” . The first part of this definition distinguishes biopharmaceuticals from chemically synthesized ‘small molecule drugs’, while the latter part excludes products produced without the use of biotechnology methods, such as blood factors extracted from donor blood . They represent some of the best accomplishments of modern science, developed through the convergence of two emerging technologies in the 1970s: genetic engineering and the science of cell culture. They are increasingly used in practically all branches of medicine and have become one of the most effective clinical treatment modalities for a broad range of diseases, including cancers, autoimmune and metabolic disorders. [3,4]
The concept of biosimilar appeared in the early 2000s and was introduced into European pharmaceutical legislation in 2003, in response to the debate that emerged in 1998, when the patent for a biologic drug on the market was about to expire . The term “biosimilar” is a regulatory term that is defined differently by legislators; the European Medicines Agency (EMA) defines a biosimilar as “a biological medicinal product containing a version of the active substance of a previously authorized biologic drug” says as a “reference biomedicine” , the Food and Drug Administration (FDA) defines it as “a biological product that is very similar to the reference product, despite minor differences in the clinically inactive components” .
We could legitimately ask the question of the interest to put biosimilars on the market; the answer is that concurrence stimulates the performance and tends to lower prices, an important stake to guarantee a wide access to the innovation for all the patients. Production of these new products is expected to meet worldwide demand, promote market competition, maintain the incentives for innovation, and sustain the healthcare systems .
We present in this article the global situation of biosimilars focusing mainly on manufacturing procedures, regulations and legislation pathways, denomination, pricing and key specifications.
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