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 The US Food and Drug Administration (FDA) announced on 27 January 2016 that it had released 35 new draft guidance documents and 12 revisions to guidance documents on bioequivalence requirements for the development of generics containing 42 different active ingredients.

27 MD002442

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.

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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 Feb 19]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-generics

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Source: USFDA

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