Regulatory pathway for approval of ‘biosimilars’ in Iran

Category: Regulatory
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Keywords: biopharmaceuticals, Iran, reference medicinal product

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 Product (RMP), present a high degree of similarity in terms of quality, safety and efficacy, and can be substituted with the RMP for the treatment of the same clinical indications.

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This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. 

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