Importantly there is significant opportunity for directly substitutable generics and branded ‘super-generics’ (i.e novel versions of generics). In addition, there is the potential of limited price erosion when generics are introduced.
The regulatory environment in Europe is conducive to accelerated development of generic, orally inhaled products, with the opportunity for regulatory approval by in vitro equivalence alone (i.e. without the need for clinical trials). In the US, the Food & Drug Administration guidelines require additional pharmacokinetic / pharmacodynamic studies.
However, because of the technical and manufacturing complexities in meeting quality standards set for approval of generics on the basis of in vitro equivalence alone, Prosonix believes it is unlikely that approval can be achieved without novel particle engineering technologies. The Company therefore expects competition to be limited.