The FDA’s October 2016 release of new bioequivalence recommendations for specific products includes draft BE guidances for umeclidinium bromide inhalation powder (Incruse Ellipta), triamcinolone acetonide nasal spray (Nasacort), and olopatadine hydrochloride nasal spray (Patanase).
For equivalents to Incruse Ellipta, in addition to recommendations for in vitro, PK, and PD testing, the FDA says that the test product formulation should be both qualitatively and quantitatively the same as the reference product and that the device should be a similar size and shape to the reference device. The device should have “similar external operating procedures as the R product” and comparable resistance. In addition the agency says that the device should be multi-dose with the same number of doses as the reference device, should be breath activated, and should have a dose counter.
The guidance for triamcinolone acetonide provides detailed instructions for in vitro and in vivo testing, while the guidance for olopatadine hydrochloride guidance recommends basic in vitro studies only. For both nasal sprays, the agency recommends that the device should be similar to the reference product in size, shape, and external operating principles.
Read the FDA BE guidance for umeclidinium bromide.
