Current overview of biosimilars in Iran

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Importance of biosimilar, a global overview Recombinant therapeutic proteins, known as biotherapeutics, are large complex molecules with an explicit three-dimensional folded structure. In last two decades, biotherapeutics achieved significant success to treat life threatening diseases and/or increase patients’ quality of life. However, the high cost of treating with these drugs has restricted their access to patients especially in un-developed and developing countries. This fact plus patent expiry of originator’s biotherapeutics expand a new generation of products which are designed to be similar to a licensed originator product. An assortment of terms such as “biosimilar products”, “follow-on protein products”, “highly similar products”, “subsequent-entry biologics” has been framed to describe these products by different regulatory agencies. Considering above, someone may ask how much similar the biosimilars should be? FDA definition of biosimilar could be the answer of this question. According to FDA guidance for industry Biosimilar or biosimilarity means that “the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components,” so “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product” [1].These differences are due to differences in host cell lines and manufacturing process. Considering the fact that two cell lines, developed independently, cannot be assumed identical, biotherapeutics cannot be fully copied of originator products and regulatory agencies such as European medicine agency (EMA) recognized this fact.

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