Can We Move Toward Harmonized Requirements for Bioequivalence of Inhalers?
Byron PR.
RDD Europe 2007. Volume , 2007: 151-158.
Abstract:
Many “off patent,” locally acting, inhaled drugs remain unavailable worldwide in the form of “generic inhalers.” The technical complexity of multi-dose inhalers and staggered device patents make them difficult to copy, but some of the delay results from different regulatory requirements that must be satisfied prior to receiving marketing approval in each world market. Furthermore, different regional regulatory approaches intended to guide the development, approval and commercialization of generic inhalers, subtly influence the regulatory requirements for new inhaled drug products. This occurs because of the need to prove that different generations of an inhaler, used, for example, in Phase II and III clinical trials are actually “BE” to one-another in accord with each region’s definition(s) of the term. This article is an attempt to describe the differences in approach that obstruct the implementation of a single, global development path leading to approval of therapeutically equivalent inhalers. It is intended to spark debate with the eventual goals of harmonizing international regulatory requirements and stimulating the international availability of alternative “off-patent drug” inhalers.
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