EMA: Draft guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues (Rev 2)

This guideline lays down the non-clinical and clinical requirements for recombinant insulin-containing products, including human insulin and insulin analogues (both referred to as insulin), claiming to be similar to another one already authorised (the reference medicinal product).

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Narodowe Centrum Badań i Rozwoju

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