An overview of the current status of follow-on biologicals in Iran

Author byline as per print journal: Farhang Rezaei, PharmD; Nassim Anjidani, PharmD Background: The advent of follow-on biologicals in Iran and biosimilars worldwide have provided various treatment options for several severe and chronic diseases. The goal of the present study was to provide an overview of their current status in Iran. Methods: A comprehensive search of […]


Regulatory pathway for approval of ‘biosimilars’ in Iran

Abstract: Iran was the first country in the MENA (Middle East and North Africa) region to publish a legal framework for the registration of biosimilars. This framework is defined by the Iranian Food and Drug Administration (IFDA). It defines biosimilars as biological products that have the same Active Pharmaceutical Ingredient (API) as the Reference Medicinal […]


Current status of biopharmaceuticals in Iran’s pharmaceutical market

Abstract: 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 […]