Finnish pharmaceutical company Orion Corporation has announced its intention to continue development of a generic budesonide/formoterol DPI despite the fact that “equivalence with the reference product, which is required under the guideline of the European Medicines Agency, was not reached” in recent studies. According to the company, study results received early this year showed that the Easyhaler product delivered consistent doses of the formulation, and the company considers the results promising enough to plan new trials to begin in early 2013.
In addition to the the generic version of Symbicort, the company points out that it is also developing a fluticasone/salmeterol Easyhaler DPI, which is a generic version of Advair (Seretide). Orion reached a deal with Nycomed last year to co-market Easyhaler products. Four single therapy products using the Easyhaler DPI are currently marketed: budesonide, formoterol, salbutamol (albuterol), and beclometasone.
Read the Orion stock exchange release.
