EMA announced on 27 November 2012 that it had been informed by Marvel LifeSciences (Marvel) that the company would be withdrawing its authorization applications for its three biosimilar human insulins.
The UK-based company formally notified EMA of its decision to withdraw Combimarv, Isomarv and Solumarv, all 100 international units/mL solution for injection. The drugs were biosimilars of Eli Lilly’s human insulin biological drug Humulin S.
The biosimilar applications were submitted to EMA on 5 December 2011, with Humulin S as the reference product, and were already under review by EMA’s Committee for Medicinal Products for Human Use (CHMP). Human insulins are used for the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis.
In its official letter, Marvel stated that ‘the decision to withdraw is in order to have sufficient time to repeat and submit bioequivalence type-1 diabetes pharmacokinetic/pharmacodynamic data on each clamp study [pivotal pharmacodynamic study] in order to comply with the planned new insulin guideline … at a validated contract research organization.’
The withdrawal may be due to EMA’s revision of its biosimilar insulin guideline. EMA released a concept paper on proposed revisions in June 2011, which was open to comment until 30 September 2011. The agency has, however, still not released revised guidance. The revision was deemed necessary by EMA due to the fact that insulin analogues and long-acting human insulin preparations were not covered by the current insulin guideline. Questions raised in the concept paper included whether the pharmacokinetic study could be combined with the pharmacodynamic study and what was the most suitable patient population and size of the clinical safety study.
More information about Combimarv, Isomarv and Solumarv, and the state of the scientific assessment by CHMP at the time of withdrawal will be made available in a question-and-answer document. This document, together with the withdrawal letter from the company, will be published on EMA’s website after the CHMP meeting of 10–13 December 2012.
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Biosimilar applications under review by EMA
Source: www.gabionline.net
