RAPS: EMA Updates its Biosimilar Insulin Guideline

The European Medicines Agency (EMA) has updated its guideline on the requirements for clinical and non-clinical development of biosimilar insulin products. The update expands the scope of the original document and gives additional detail on study design parameters. EMA recently finalized its guideline on “similar biological medicinal products”—commonly referred to as biosimilars—which will enter into effect in April 2015. Biosimilars are products that are similar to an already authorized biological product, and can be considered equal to their reference product in terms of safety, efficacy, quality and biological activity.

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