Prosonix’ generic version of GSK’s Flixotide Evohaler under review in EU

UK-based Prosonix, a speciality pharmaceutical company developing a portfolio of inhaled respiratory medicines “by design,” says its Marketing Authorization Application for PSX1001 has been validated and is being assessed under the decentralized procedure (DCP).

Prosonix has submitted the primary MAA under the DCP and a simultaneous duplicate MAA on behalf of US generic drugmaker Mylan (Nasdaq: MYL). The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is the reference member state.

The MAA submission for PSX1001 leverages the European Union regulatory guideline CPMP/EW/4151/00 Rev. 1 that potentially allows the approval of generic inhaled products on the basis of in vitro only demonstration of therapeutic equivalence of the candidate to the reference product.