FDA releases 67 new and revised bioequivalence guidelines for generics

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FDA releases 67 new and revised bioequivalence guidelines for generics

INICIO/Directrices | Posted 18/11/2016 0 Post your comment

As part of its ongoing efforts to provide product specific guidance for generics makers the US Food and Drug Administration (FDA) has again released a whole host of new bioequivalence documents. The agency announced on 1 October 2016 that it had released 34 new draft guidance documents and 33 revisions to guidance documents on bioequivalence requirements for the development of generics containing 59 different active ingredients.

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 The agency also released 31 new draft guidance documents and 11 revisions in January 2016. This was followed by 19 new draft guidance documents and 19 revisions in June 2016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

Active ingredient	Route of administration	Dosage form	Link
Acetaminophen/ oxycodone hydrochloride	Oral	Tablet ER	Click here
Alectinib hydrochloride	Oral	Capsule	Click here
Betamethasone dipropionate	Topical	Cream	Click here
Betamethasone valerate	Topical	Ointment	Click here
Captopril	Oral	Tablet	Click here
Carbidopa/levodopa	Oral	Tablet	Click here
Cholic acid	Oral	Capsule	Click here
Clobetasol propionate	Topical	Cream (emollient)	Click here
Clobetasol propionate	Topical	Gel	Click here
Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide fumarate	Oral	Tablet	Click here
Crotamiton	Topical	Cream	Click here
Crotamiton	Topical	Lotion	Click here
Desonide	Topical	Ointment	Click here
Dexlansoprazole	Oral	Tablet DR/OR	Click here
Elbasvir/grazoprevir	Oral	Tablet	Click here
Eltrombopag olamine	Oral	Suspension	Click here
Esomeprazole magnesium	Oral	Tablet DR	Click here
Fluticasone propionate	Topical	Ointment	Click here
Halobetasol propionate	Topical	Lotion	Click here
Hydrocodone bitartrate	Oral	Capsule ER	Click here
Hydrocodone bitartrate	Oral	Tablet ER	Click here
Hydrocortisone valerate	Topical	Ointment	Click here
Ibuprofen	Oral	Suspension	Click here
Iron dextran	Injectable	Injection	Click here
Methylphenidate HCl	Oral	Tablet, chewable	Click here
Morphine sulfate	Oral	Solution	Click here
Olopatadine HCI	Nasal	Spray, metered	Click here
Oxymorphone HCl	Oral	Tablet ER	Click here
Prochlorperazine	Rectal	Suppository	Click here
Pyrazinamide	Oral	Tablet	Click here
Rolapitant	Oral	Tablet	Click here
Triamcinolone acetonide	Nasal	Spray, metered	Click here
Triamcinolone acetonide	Topical	Ointment	Click here
Umeclidinium bromide	Inhalation	Powder	Click here
ER: extended release; DR: delayed release; OD: orally disintegrating.

Table 2: FDA revised draft bioequivalence guidance documents

Active ingredient	Route of administration	Dosage form	Link
Bacitracin	Ophthalmic	Ointment	Click here
Buprenorphine	Transdermal	Film ER	Click here
Cyclosporine	Ophthalmic	Emulsion	Click here
Dexlansoprazole	Oral	Capsule DR	Click here
Diclofenac epolamine	Topical	Patch	Click here
Erythromycin	Ophthalmic	Ointment	Click here
Estradiol (Orange book 203752)	Transdermal	Film ER	Click here
Estradiol (Orange book 19081)	Transdermal	Film ER	Click here
Estradiol (Orange book 20375/21674)	Transdermal	Film ER	Click here
Estradiol (Orange book 20538)	Transdermal	Film ER	Click here
Ethinyl estradiol/norelgestromin	Transdermal	Film ER	Click here
Fentanyl	Transdermal	Film ER	Click here
Granisetron	Transdermal	Film ER	Click here
Icosapent ethyl	Oral	Capsule	Click here
Lansoprazole	Oral	Tablet DR/OD	Click here
Lidocaine	Topical	Patch	Click here
Menthol/methyl salicylate	Topical	Patch	Click here
Mesalamine	Oral	Tablet DR	Click here
Methylphenidate	Transdermal	Film ER	Click here
Morphine sulfate	Oral	Capsule ER	Click here
Nicotine	Transdermal	Film ER	Click here
Nitroglycerin (Orange book 20145)	Transdermal	Film ER	Click here
Nitroglycerin (Orange book 20145)	Transdermal	Film ER	Click here
Omega-3-acid ethyl esters	Oral	Capsule	Click here
Oxycodone HCl	Oral	Tablet ER	Click here
Oxybutynin	Transdermal	Film ER	Click here
Pantoprazole sodium	Oral	Granules DR suspension	Click here
Rivastigmine	Transdermal	Film ER	Click here
Rotigotine	Transdermal	Film ER	Click here
Scopolamine	Transdermal	Film ER	Click here
Selegiline	Transdermal	Film ER	Click here
Testosterone	Transdermal	Film ER	Click here
ER: extended release; DR: delayed release; OD: orally disintegrating.

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.

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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Source: FDA