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FDA releases 47 new and revised bioequivalence guidelines for generics

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Generics makers have a whole host of new bioequivalence documents to go through. The US Food and Drug Administration (FDA) announced on 27 January 2016 that it had released 35 new draft guidance documents and 12 revisions to guidance documents on bioequivalence requirements for the development of generics containing 42 different active ingredients.

The new draft bioequivalence guidance documents cover generics of oral contraceptive ethinyl estradiol/norethindrone acetate, antipsychotic Zyprexa (olanzapine), corticosteroid drug prednisone and acid relux treatment Zantac (ranitidine), among others, see Table 1.

Revised bioequivalence guidance documents include those for generics of menopause hot flashes treatment drospirenone/estradiol, attention deficit hyperactivity disorder (ADHD) treatment Estulic/Tenex (guanfacine) and Alzheimer’s/Parkinson’s Disease treatment Exelon (rivastigmine), see Table 2.

Table 1: FDA new draft bioequivalence guidance documents

Active ingredient	Route of administration	Dosage form	Link
Alprostadil	Urethral	Supository	Click here
Atazanavir sulfate/cobicistat	Oral	Tablet	Click here
Beclomethasone dipropionate	Inhalation	Metered aerosol	Click here
Betamethasone dipropionate	Topical	Lotion (augmented)	Click here
Betamethasone valerate	Topical	Lotion	Click here
Betaxolol HCI	Ophthalmic	Suspension/drops	Click here
Ciclesonide	Inhalation	Metered aerosol	Click here
Clobetasol propionate	Topical	Ointment	Click here
Desonide	Topical	Cream	Click here
Desonide	Topical	Lotion	Click here
Diflorasone diacetate (Orange book 075508)	Topical	Cream	Click here
Diflorasone diacetate (Orange book 076263)	Topical	Cream	Click here
Difluprednate	Ophthalmic	Emulsion	Click here
Elvitegravir	Oral	Tablet	Click here
Erythromycin	Oral	Tablet	Click here
Ethinyl estradiol/norethindrone acetate	Oral	Tablet	Click here
Flurandrenolide	Topical	Lotion	Click here
Formoterol fumarate/mometasone furoate	Inhalation	Metered aerosol	Click here
Ingenol mebutate	Topical	Gel (0.05%)	Click here
Ingenol mebutate	Topical	Gel (0.015%)	Click here
Mercaptopurine	Oral	Suspension	Click here
Methylphenidate HCl	Oral	ER Capsule	Click here
Metronidazole	Oral	Capsule	Click here
Mometasone furoate	Topical	Ointment	Click here
Naftifine HCl	Topical	Cream	Click here
Naftifine HCl	Topical	Gel	Click here
Nicotine	Nasal	Metered spray	Click here
Olanzapine pamoate	Intramuscular	ER suspension	Click here
Omega-3 carboxylic acids	Oral	Capsule	Click here
Prednisone	Oral	Tablet	Click here
Ranitidine HCl	Oral	Capsule	Click here
Riociguat	Oral	Tablet	Click here
Spinosad	Topical	Suspension	Click here
Trametinib dimethyl sulfoxide	Oral	Tablet	Click here
Vorapaxar sulfate	Oral	Tablet	Click here
ER: extended release; HCI: hydrochloride.

Table 2: FDA revised draft bioequivalence guidance documents

Active ingredient	Route of administration	Dosage form	Link
Abiraterone acetate	Oral	Tablet	Click here
Amphotericin B	Injection	Liposome	Click here
Ciprofloxacin HCl/hydrocortisone	Otic	Suspension/drops	Click here
Colesevelam HCl	Oral	Powder, suspension	Click here
Drospirenone/estradiol	Oral	Tablet	Click here
Guanfacine HCl	Oral	ER tablet	Click here
Lamotrigine	Oral	ER tablet	Click here
Lidocaine	Topical	Patch	Click here
Lomitapide mesylate	Oral	Capsule	Click here
Methylphenidate HCl	Oral	ER capsule	Click here
Phytonadione	Oral	Tablet	Click here
Rivastigmine Tartrate	Oral	Capsule	Click here
ER: extended release; HCI: hydrochloride.

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 time points and analytes to be measured in blood samples are also detailed in the draft guidance documents.

In total, FDA now has 1,397 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 Feb 19]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-generics

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Source: USFDA