Generic Inhalation Product

When developing a generic product, the main objective is to prove therapeutic equivalence to the originator product.

According to the European guidance CPMP/ EWP/4151/00 rev 1, the equivalence includes a general equivalence i.e. API equivalence, formu- lation equivalence and device equivalence. The product must also demonstrate either In-Vitro equivalence, PK-equivalence or PD-equivalence.

The development programme therefore starts with a selection of a device that can be made equivalent to the originator. If the originator devi- ce is e.g. a capsule device ICOcap is selected and a requirement speci cation is generated to detail how the device must be adapted to match the ori- ginator. In parallel with this the drug formulation is developed by either the client or by an Iconovo partner. The gure below shows a high level description of a development process. All Iconovo development programmes start by developing a detailed project plan together with the client. The project plan includes all key activities, delivera- bles, acceptance criteria and milestones.