Biosimilars (09/09/2015) Vol. 2015, No. 5, P. 65; Mikhail, Ashraf; Brown, Christopher

Licensing guidelines for biosimilar products vary across nations and regions, demonstrating the difficulties in defining biosimilars, determining how to assess their equivalence in efficacy, and monitoring their long-term safety. Researchers reviewed some of the differences between the European Medicines Agency and the U.S. Food and Drug Administration in licensing requirements for biosimilars. Specifically, they focused on the pathway taken by the manufacturer of the biosimilar epoetin zeta as it sought approval in Europe. The authors note that as "many patients are likely to be switched from original drugs to biosimilars in future, there is a need to establish strict guidelines on interchangeability and substitution of biosimilars and original products and to make it an integral part of the pre-registration assessment of any biosimilar in future." In addition, long-term, observational post-marketing data can provide further information on the drugs' safety and tolerability.

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