Marvel LifeSciences drops EU application for three human insulin biosimilars

27 November 2012

The European Medicines Agency said yesterday that it has been formally notified by UK-based Marvel LifeScience Ltd of its decision to withdraw its applications for centralized marketing authorisations for the medicines Solumarv, Isomarv and Combimarv (human insulin), all 100 IU/ml solution for injection.

The products were intended to be used for the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis. The medicines were developed as “biosimilar” medicines. This means that they are similar to a biological medicine already authorised in the European Union that contains the same active substance (also known as the reference medicine), Humulin S from Eli Lilly.

The applications for the marketing authorization for Solumarv, Isomarv and Combimarv were submitted to the Agency on December 5, 2011. At the time of the withdrawal, all three medicines were under review by the Agency's Committee for Medicinal Products for Human Use (CHMP).

Company needs time to repeat and submit bioequivalence data

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