Therapeutic Equivalence of Inhaled Corticosteroids - Workshop on Regional Differences in Regulatory Requirements
Fuglsang A, Leach CL, Mayers I, Chowdhury BA.
Respiratory Drug Delivery 2008. Volume 1, 2008: 133-150.
Abstract:
Many “off patent,” locally acting, inhaled corticosteroid (ICS) drugs remain unavailable worldwide, even though these drugs already exist in multiple inhaler formats in some markets. In practice, once more than one inhaler containing the same drug substance is allowed to join a regional market, health professionals and patients tend to assume that these are therapeutically interchangeable, irrespective of information leaflets provided with the products that may highlight their differences. This article is an attempt to describe and debate the issues that confront regulators, when companies attempt to launch therapeutically equivalent (TE), but differently designed, steroid inhalers containing the same drug in North America and Europe.
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