EMA publishes draft guideline on biosimilar insulin products

December 19, 2012 6:15 AM

European Medicines Agency (EMA), the pioneer in the development of biosimilars, issued a new draft guideline for biosimilar insulin products and waiting for public comments till the end of June 2013.

The draft guideline, “Non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues” was published at the end of last week and can be reached from here.

The guideline on development of biosimilar human insulin and insulin analogues was first finalized and approved in February 2006 in the European Union. In November 2012, EMA’s Biosimilar Medicinal Products Working Party (BMWP) released a draft revision of the policy, which was adopted by the CHMP on 13 December and released to the public last Friday.


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