Bioequivalence and Bioavailability Forum

Good evening Geokad!

Insulin is an SEB (Subsequent Entry Biologic), i.e. we are looking for similarity of the process, not only the products' in-vivo perfomances.

First have a look at the SEB draft (2010). It contains the strange requirement to assess clearance and half-life. Maybe they copypasted from EMA's GL?
I don't get the point, because CL=D/AUC_inf, where AUC_inf=AUC_t+C_t/k_el and k_el=ln(2)/t_½.
BTW, what are distributions of CL and t_½?

I would opt for a parallel design, because I have seen significant sequence effects in all (!) cross-over studies. Canada's draft is quite vague...

Have a look across the pond. Here are EMA's Guidelines for Biosimilars. There you may find all general ones, as well as the one for Insulin as a starter.