The advent of biosimilars and follow-on biologics in Iran has provided various treatment options for several severe and chronic diseases. The goal of the present study was to provide an overview of their situation in Iran. Methods
In order to summarize available evidence for biosimilars in Iran, we conducted a comprehensive search on the clinical trial registry sites as well as other databases that publish scholarly articles, such as PubMed and google scholar. In addition, we analyzed the annual national wholesale data of pharmaceutical products published by the Iranian pharmaceutical regulatory. The share of biotechnological therapeutics from the total medicines market was evaluated along with the share of biosimilars and follow-on biologics and the potential and actualized cost-saving associated with using them was assessed. Results
Currently, 21 biosimilars and follow-on biologics are available in Iran that are related to 17 different molecules. In 2018, about 13.5% of health care spending on medicines in Iran was devoted to biotechnological therapeutics. Biosimilars and follow-on biologics comprised approximately 47.2% of the biotechnological therapeutics’ total market value, up from 35.2% in 2013. The use of biosimilars and follow-on biologics in Iran was associated with more than 300 million dollars cost-saving in 2018. A number of biosimilar candidates, mostly monoclonal antibodies, are under development and can be marketed after fulfilment of their study objectives during head-to-head clinical trials and gaining regulatory approval. Conclusion
Despite significant rise in the use of biosimilars and follow-on biologics in Iran, the proportional use of biotechnological therapeutics compared to the total market of medicines has remained the same during recent years. Iranian health care authorities can improve patients’ access to life saving biological medicines through promoting the use of biosimilars instead of costly originators after making sure of the quality, efficacy, and safety of the biosimilars. The significant cost saving associated with using biosimilars can also be utilized for other biotechnological medicines that are not currently in the Iran’s drug list.
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