EMA: Concept paper on the revision of the guideline on nonclinical and clinical development of similar biological medicinal products containing recombinant human insulin

The current Guidance on Similar Medicinal Products containing Recombinant Human Insulin provides recommendations for the development of recombinant soluble (short-acting) human insulin claimed to be similar to a reference product already authorised in the EU. This guideline came into effect in June 2006 but, so far, no biosimilar insulin has been licensed in the EU. Three products applied for by the same Applicant were withdrawn prior to Opinion.