karma,

Good question. There actually is a lot of technology in the inhaler; and the Technosphere powder has unique properties as well that allow it to be carried deep into the lungs. As to the inhaler, you would want to prove that the dose is consistently and effectively delivered deep into the lungs. Certainly the in vitro studies might give a good indication as to equivalency, but you would still want to demonstrate that it has a similar effect in vivo.