Why bioequivalence requirements for OINDPs are not adequate

Why bioequivalence requirements for OINDPs are not adequate

July 14, 2016

Those of you developing generic versions of Advair Diskus have long known this: the PK (and let’s face it in vitro as well) inter-batch variability of the originator is such that it would never be bioequivalent to itself. Companies have amassed data on this but few have published it.

So, congratulations to Elise Burmeister Getz and her team at Oriel in the US for having carried out an excellent PK study on Advair Diskus 100/50 demonstrating this variability and the near impossibility for Advair Diskus to be bio-equivalent to itself according to current guidelines. The study has been published in Clinical Pharmacology and Therapeutics 2016: Batch-to-batch pharmacokinetic variability confounds current bioequivalence regulations: A dry powder inhaler randomized clinical trial

Earlier in 2016 Elise and the team had published a poster at ATS 2016: Clinical Endpoint Bioequivalence Study Of Salmeterol Xinafoate (SX)/Fluticasone Propionate (FP) Combination Brand And Generic Candidate Products In Patients With Asthma. In this paper they demonstrated that they could achieve PD BE with their 100/50 test product against the Advair Diskus reference.

Elise and the team thus provide the missing link in the BE debate: yes PD BE can be achieved even when PK BE is not achieved. This certainly puts in question the current regulations on BE burden of proof.

I am delighted that Oriel so willingly published their data. Their work is of high quality. This is a great contribution to the scientific debate for which they should be warmly congratulated.

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