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Therapeutic Equivalence for Orally Inhaled Products in Europe: An Update and Counterpoint to the 505(j) Approval Process

Dissanayake S.

Respiratory Drug Delivery 2018. Volume 1, 2018: 237-254.

Abstract:

The guideline for generic orally inhaled products (OIPs) in the European Union (EU) is reviewed critically with a focus on three key aspects within it that warrant consideration. Requirements that are more appropriate for new chemical entities than generic products, impractical clinical demands that extend beyond those needed to reasonably assure favorable benefit:risk ratios, and recommendations that lack a supportive evidence base and/or logic are discussed. Ultimately, these guidelines have important implications not only for generic drug companies but also for national healthcare systems throughout the EU: they are needed to preclude the maintenance of high pricing well after market exclusivity for the innovator has expired. In the next iteration of the guideline, the European regulatory authorities should carefully consider both progress since 2009, as well as experience suggesting the need for guideline modification.