Generics are the same or similar?

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Abstract

This presentation will briefly summarize the requirements for bio-equivalence according to the European legislation (E.M.E.A.) The different requirements for systemic and non-systemic generics will then be clarified as well as their implications for topical ophtalmic medications. Six different elements that might interfere with therapeutic equivalence of brand and generic ophthalmic formulations are considered: inactive ingredients, bottle design and drop size, stabilizers, Ph stability, temperature stability, and presence of particulate matter. A number of studies comparing brand and generic opthalmic drugs will be presented. Finally, the cost saving aspect of generic ophthalmic drugs is analyzed with particular reference to the Belgian situation.

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