Abstract

The rise of biosimilar provides an opportunity for healthcare systems worldwide to reduce costs and ensure affordability as well as accessibility of these pivotal products. This is particularly the case in developing countries with restricted budgets to guarantee the availability of safe and cost-effective drugs. Accordingly, this paper aims to study Iranian pharmaceutical industry to show the development of the biosimilar sector, which has emerged in the wake of an intense global interest in the production and marketing of biosimilar. This paper adopted a descriptive cross-sectional method to investigate the Iranian pharmaceutical industry by focusing on biosimilar products over a fifteen-year period (2002-2016). Results obtained showed an upward trend in the domestic production of biosimilars, which has helped secure the first place for the country in the Middle East. In addition, Iran has laid down strict regulatory guidelines for the approval of locally produced biosimilar. The findings also highlight the significant savings generated for the healthcare system thanks to the manufacturing of non-innovator products. These results suggested that observing global regulatory guidelines and providing safe and cost-effective biosimilars are imperative for health care systems in all countries interested in this promising market.