Current status of biopharmaceuticals in Iran’s pharmaceutical market

The clinical importance of biopharmaceuticals for the management of life threatening diseases is increasing but costs have become a major obstacle to the administration of these medicines, especially in resource limited healthcare systems. Introduction of biosimilars as a cost-effective alternative to innovator biopharmaceuticals has attracted the attention of both industry and policymakers. However, due to the complex structures of biopharmaceuticals, the regulation of biosimilars has become challenging for national regulatory authorities. In the past decade, national pharmaceutical companies in Iran have manufactured copies of several brand-name biopharmaceuticals. Although copied biopharmaceuticals produced by Iranian companies have received marketing authorization for the local market, none has been evaluated using internationally recognized guidelines for the approval of biosimilars. Therefore, effective pharmacovigilance programmes are essential to evaluate whether the safety and efficacy profiles of these locally produced biopharmaceuticals are different from those of either the original brand biopharmaceuticals or their biosimilar versions.