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FDA releases 67 new and revised bioequivalence guidelines for generics Posted 18/11/2016

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 The agency announced on 1 October 2016 that it had released 34 new draft guidance documents and 33 revisions to guidance documents on bioequivalence requirements for the development of generics containing 59 different active ingredients.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 The agency also released 31 new draft guidance documents and 11 revisions in January 2016. This was followed by 19 new draft guidance documents and 19 revisions in June 2016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

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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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Source: FDA

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