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How the EU and US Are Aligning Guidance for Inhalation Products

Generic inhaled products pose additional challenges for developers when compared to an oral dosage form. Not only must the drug itself be proved equivalent to the originator, the developer must also satisfy the regulators that the combination of drug, along with its delivery device, are equivalent.

The timelines are also somewhat different to those for an originator inhaled product – for the originator, the whole development process can take a decade or more, so the final ‘to be marketed’ device design does not need to be considered at the outset; however, for a generic, the shorter development time means that the choice of final device design cannot be delayed.

In the US, the FDA demands that a company developing any generic product must prove it meets three criteria: pharmaceutical equivalence, bioequivalence, and therapeutic equivalence. A generic is deemed pharmaceutically equivalent if it contains the same active ingredients as the reference product, is administered using the same dosage form and route of administration, has the same strength, and also meets all compendial standards for quality, purity, and identity.

Bioequivalence is achieved if there is no significant difference in the rate or extent of absorption of the active ingredient at the site of action. For an inhaled product, the site of action is a mucosal surface in the lung, and therefore, it is very difficult to measure directly.

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Martin Oliver is Senior Vice President of Delivery Management – DPI & pMDI Platform at Vectura, a specialist inhalation CDMO. Vectura has a Joint Venture in China, the Tianjin Kinnovata Pharmaceutical Co. Ltd, to establish DPI products for the region, where Martin also acts as the Deputy Chairman on the board. He holds a Bachelor of Pharmacy degree from the University of Bradford, UK.
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