Bioequivalence and Bioavailability Forum

Hi Lechia,

❝ Anyone with experience showing BE for nasal sprays for EMA?

Yes

❝ Are all 3 of:

❝

❝   – in vitro analyses

❝   – PK

❝   – therapeutic equivalence

❝

❝ required for a generic product to be accepted on the market?

Generally, no, not at all. It may be much easier than that.

❝ There is a guidance discussing all in vitro assays required for EMA, but nothing on what in vivo studies must (also) be performed. I would appreciate any guidance, especially if based on experience.

You may indee be able to pull it off with in vitro data. If that doesn't work, you may resort to PK or PD. There is no unified view on it across EU countries, so pick your RMS well. And do not pick according to your most imæportant market or where your EU Headquarters is...