The new draft bioequivalence guidance documents cover generics of non-steroidal anti-inflammatory drug (NSAID) painkiller ibuprofen, HIV treatment Viread (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide), acid reflux treatment Nexium (esomeprazole) and oral corticosteroid triamcinolone, among others, see Table 1.

Revised bioequivalence guidance documents include those for generics of NSAID arthritis treatment diclofenac, menopause hot flashes treatment estradiol, oral contraceptive ethinyl estradiol/norethindrone acetate and Alzheimer’s/Parkinson’s disease treatment Exelon (rivastigmine), among others, see Table 2.

This is the third time FDA has released new and revised bioequivalence guidance for generics in 2016. The agency also released 31 new draft guidance documents and 11 revisions in January 2016. This was followed by 19 new draft guidance documents and 19 revisions in June 2016

Table 1: FDA new draft bioequivalence guidance documents

Table 2: FDA revised draft bioequivalence guidance documents

The draft guidance documents recommend what in vivo and in vitro studies generics companies should carry out in order to demonstrate bioequivalence. The number of studies, the population to be studied, blood sampling timepoints and analytes to be measured in blood samples are also detailed in the draft guidance documents.

In total, FDA now has 1,523 product-specific guidelines with bioequivalence study recommendations. The agency also has an overarching guidance document on bioequivalence recommendations for specific products [1].

Comments on the draft guidance documents can be posted to the Division of Dockets Management (DDM) under Docket FDA-2007-D-0369-0015. This can be done via the website www.regulations.gov or written comments can be mailed to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. US guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 18]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-generics

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