Biosimilars; a unique opportunity for Iran national health sector and national pharmaceutical industry

Despite complexity of their molecules, biopharmaceuticals are very well characterized both for their clinical use and production methods. Biopharmaceuticals are also very sensitive to their production procedures. When the manufacturing process is modified by scaling up or transferring it to alternative facilities, new products might show modified specifications. Even though these manufacturing changes are tightly regulated most of the time they still will cause observable changes in the final product. However, all of these products will be marketed under one single brand name indicating that regulators consider these changes in the range of “highly similar” products. The fact that their administration provides expected clinical outcomes also confirm their comparability.“Biosimilars” are biopharmaceuticals which are manufactured by non originator pharmaceutical companies following expiration of patent period. According to current guidelines and regulations for granting marketing authorization “similarity” should be proven between biosimilar and its corresponding originator biopharmaceutical.Biopharmaceuticals have a very fast growing market. It is reported that 32% of products in development pipeline and 7.5% of marketed medicines are biopharmaceuticals which account for around 10% of pharmaceutical expenditure [3]. It is forecasted that by 2020, biopharmaceuticals will sell around US$23 billion in the EU and US$29 billion in the USA and of course all of this market could be challenged by biosimilars [3]. The biopharmaceutical market has expanded drastically in the past two decades. Although most of these medicines enjoyed exclusivity in the market due to their patent; recent years have witnessed expiration of their patent.Since in coming years more and more biopharmaceuticals will lose their patent protection, many pharmaceutical companies including biotechnology industry and generics manufacturers, as well as regulatory agencies, are becoming increasingly intereste