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Oct 5, 2015

Jordan FDA Issues a Guideline for the Registration of Biosimilars

Recently, the Jordan Food and Drug Administration (JFDA) issued a guideline regarding the registration of biosimilars. Much of the information used to develop the guideline was adopted from the European Medicines Agency (EMA) guidelines. Definitions The guideline defines "reference product" and "biosimilar product" as follows: "Reference product" refers to an innovator biological medicinal product already […]
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