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 The agency announced on 1 October 2016 that it had released 34 new draft guidance documents and 33 revisions to guidance documents on bioequivalence requirements for the development of generics containing 59 different active ingredients.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 The agency also released 31 new draft guidance documents and 11 revisions in January 2016. This was followed by 19 new draft guidance documents and 19 revisions in June 2016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.
Related article
Doctors in the US should remember to prescribe generics
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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