Are drugs with the same International Non-proprietary Name (INN) substitutable? Analysis of international experience with cyclosporine

S. L. Plavinski
North-West State Medical University named after I. I. Mechnikov, Russia

The analysis of policy related to International Non-proprietary Name (INN) substitution in different countries is undertaken with cyclosporine as example. It is shown that regulatory policy is different in different countries with majority leaving decision on substitution to physician. Professional associations are opposing to INN substitution for cyclosporine without physician knowledge and agreement despite the fact that European regulatory agency place higher demands demonstration of bioequivalence.

generics, bioequivalence, cyclosporine, regulatory policy regarding drugs

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