Biosimilar Labelling: a regulatory conundrum
The future for the biosimilars market is predicted to be golden.
Various biosimilar products are now available in Europe, the USA and globally. However, there is increasing concern over how products should be labelled to ensure safety and efficacy. In March 2016, the US Food and Drug Administration released draft guidance notes for the labelling of biosimilar products in which detailed suggested guidelines for new products are outlined. Finalisation of these notes is still under review. In Europe, similar discussions are under way. Read the full summary: US FDA proposals for naming of biologicals and labelling of biosimilars.
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