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

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 clinical trial registry sites and other databases that publish scholarly articles, such as PubMed and Google scholar, enabled the current follow-on biologicals landscape in Iran to be mapped. In addition, the annual national wholesale data of pharmaceutical products published by the Iranian pharmaceutical regulatory were analysed. The share of biotechnological therapeutics in terms of the whole medicines market, was evaluated, along with the share of follow-on biologicals and the potential and actualized cost-saving associated with using them. Data were collected and analysed over the 2013-2018 time period. Results: At the time of writing, 21 follow-on biologicals were available in Iran and these represent 17 different originator molecules. In 2018, approximately 13.5% of medicines spending in Iran was devoted to biotechnological therapeutics. Follow-on biologicals comprised approximately 47.2% of the biotechnological therapeutics' total market value, up from 35.2% in 2013. The use of follow- on biologicals in Iran was associated with more than US$300 million cost-saving in 2018. A number of follow-on biological candidates, mostly monoclonal antibodies, are under development and will be subject to head-to-head clinical trials against originator products prior to regulatory approval and marketing. Conclusion: Despite a significant rise in the use of follow-on biologicals in Iran, the proportional use of biotechnological therapeutics compared to the total medicines market has remained constant in recent years. Iranian healthcare authorities can improve patients' access to life-saving biological medicines through promoting the use of follow-on biologicals instead of costly originators after making sure of the quality, effi cacy and safety of the follow- on biologicals. The signifi cant cost saving associated with using follow-on biologicals can also be utilized for other biotechnological medicines that are not currently in Iran's drug list.