Rejected biosimilars: the Insulin Human Rapid Marvel case

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Rejected biosimilars: the Insulin Human Rapid Marvel case

Biosimilares/Investigación | Posted 30/07/2009 0 Post your comment

On 20 December 2007, Marvel LifeSciences Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) of the EMEA that it wished to withdraw its applications for marketing authorisations for Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel (active substance: insulin human), for the treatment of diabetes mellitus.

Recombinant Human Insulin in regular (uncomplexed), isophane or NPH (long-acting) and a 30/70 mix formulation, was filed as a biosimilar comparable to Humulin, its isophane product and 30/70 mix. Each formulation was a solution for injection containing 100 International Units of insulin per milliliter, packaged in vials or as cartridges to be used in injection pens. These products were developed by Marvel LifeSciences as biosimilars, with the reference products for regular insulin being Humulin S, Humulin I and Humulin M3 from Eli Lilly & Co. They were (co)manufactured by Diosynth (Akzo Nobel), presumably in E. coli bacteria.

The company presented data from studies designed to show that the Marvel insulins were comparable with the reference medicines in experimental models and in humans. The company presented the results of studies carried out in 24 healthy volunteers looking at the effect of the Marvel insulins on blood sugar levels, compared with the Humulin insulins. It also presented the results of one main study in 526 patients with diabetes, who received either the Marvel insulins or the Humulin insulins for up to 12 months. The main measure of effectiveness was the effect of the medicines on the levels of glycosylated haemoglobin (HbA1c).

Based on the review of the data, the CHMP concluded that the comparability of the Marvel insulins and the Humulin insulins had not been shown. The studies in healthy volunteers did not show that the Marvel insulins had the same effect in lowering blood sugar levels as the Humulin insulins, and the main study showed a trend in favour of Humulin. The CHMP also concluded that the company had not supplied enough information on how the active substance or the finished products are made, and that the processes used to make them had not been validated. Therefore it was of the provisional opinion that Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel could not have been approved for the treatment of diabetes mellitus. At day 120 the company withdrew its three applications and there are currently no clinical trials or compassionate use programmes with the Marvel insulins.

Source: EMEA, Biopharma