Human insulin and insulin analogues are used to treat patients with diabetes mellitus. In these patients the pancreas does not produce enough insulin or the body’s cells fail to respond to the insulin being produced (insulin resistance), causing the blood to contain too much glucose (hyperglycaemia). Human insulin and insulin analogues stimulate the cells within the body to take up glucose in the blood, either for immediate energy or for storing as glycogen in the liver and muscle cells, thus reducing blood glucose levels. Fifteen different medicinal products containing human insulin or insulin analogues are currently approved in the EU for treatment of diabetes mellitus.

Unlike many medicines, insulin currently cannot be taken orally because, like nearly all other proteins introduced into the gastrointestinal tract, it is reduced to fragments (even single amino acid components), whereupon all activity is lost. Insulin is usually taken as subcutaneous injections by single-use syringes with needles, via an insulin pump or by repeated-use insulin pens with needles.

The proposed guideline lays down the non-clinical and clinical requirements for recombinant insulin containing products, including human insulin and insulin analogues, claiming to be similar to another one already marketed. The non-clinical section addresses the pharmaco-toxicological assessment. The clinical section addresses the requirements for pharmacokinetic, pharmacodynamic and safety studies, as well as the risk management plan.

Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues EMA/CHMP/BMWP/652000/2010
Date: 13 December 2012
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/12/WC500136392.pdf

Feedback on the draft guideline can be submitted to EMA until the end of June 2013.

The guideline, once finalized, is intended to replace EMA’s existing guideline on biosimilar human insulin (EMEA/CHMP/BMWP/32775/2005), which was approved in June 2006.

Related article

EU guidelines for biosimilars

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