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FDA releases 53 new and revised bioequivalence guidelines for generics

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On 12 December 2014, the US Food and Drug Administration (FDA) released 31 new draft guidance documents and 22 revisions to guidance documents on bioequivalence requirements for the development of generics containing 42 different active ingredients.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 acne treatment Aczone (dapsone), antipsychotic medication Latuda, (lurasidone), chemotherapy drug Stivarga (regorafenib), HIV medicine Stribild (cobicistat/elvitegravir/emtricitabine/tenofovir), head lice treatment Ulesfia (benzyl alcohol) and arthritis treatment Xeljanz (tofacitinib), among others, see Table 1.

Revised bioequivalence guidance documents include those for generics of high blood pressure treatment Bystolic (nebivolol), chemotherapy drug Doxil (doxorubicin), acne treatment Epiduo (adapalene/benzoyl peroxide) and Alzheimer’s drug Namenda (memantine), to name just a few, see Table 2.

Table 1: FDA new draft bioequivalence guidance documents

Active ingredient	Route of administration	Dosage form	Link
Acetaminophen/aspirin/caffeine	Oral	Tablet	Click here
Acetaminophen/butalbital/caffeine/codeine phosphate	Oral	Capsule	Click here
Acyclovir	Topical	Cream, 5%	Click here
Aripiprazole	Intramuscular	Injectable Suspension, Extended Release	Click here
Benzyl alcohol	Topical	Lotion	Click here
Betamethasone valerate	Topical	Foam, Aerosol	Click here
Bosutinib monohydrate	Oral	Tablet	Click here
Brimonidine tartrate/brinzolamide	Ophthalmic	Drops, Suspension	Click here
Budesonide	Oral	Tablet, Extended Release	Click here
Buprenorphine HCl/naloxone HCl	Oral	Tablet, Sublingual	Click here
Cobicistat/elvitegravir/emtricitabine/tenofovir disoproxil fumarate	Oral	Tablet	Click here
Conjugated estrogens	Oral	Tablet	Click here
Dapsone	Topical	Gel, 5%	Click here
Darunavir ethanolate	Oral	Suspension	Click here
Ibuprofen sodium	Oral	Tablet	Click here
Levothyroxine sodium	Oral	Tablet	Click here
Lidocaine/prilocaine	Topical	Cream	Click here
Lomitapide mesylate	Oral	Capsule	Click here
Lurasidone HCl	Oral	Tablet	Click here
Methylphenidate HCl	Oral	Suspension,Extended Release	Click here
Metoprolol tartrate	Oral	Tablet	Click here
Nepafenac	Ophthalmic	Drops, Suspension 0.1%	Click here
Nepafenac	Ophthalmic	Drops, Suspension 0.3%	Click here
Posaconazole	Oral	Tablet, Delayed Release	Click here
Raltegravir potassium	Oral	Tablet, Chewable	Click here
Regorafenib	Oral	Tablet	Click here
Selegiline hydrochloride	Oral	Capsule	Click here
Testosterone	Transdermal	Film, Extended Release	Click here
Tofacitinib citrate	Oral	Tablet	Click here
Treprostinil diolamine	Oral	Tablet, Extended Release	Click here
Vandetanib	Oral	Tablet	Click here

Table 2: FDA revised draft bioequivalence guidance documents

Active ingredient	Route of administration	Dosage form	Link
Adapalene	Topical	Lotion	Click here
Adapalene	Topical	Cream	Click here
Adapalene	Topical	Gel	Click here
Adapalene	Topical	Gel	Click here
Adapalene/benzoyl peroxide	Topical	Gel	Click here
Brimonidine tartrate	Ophthalmic	Solution/Drops 0.1%	Click here
Brimonidine tartrate	Ophthalmic	Solution/Drops 0.2%	Click here
Brimonidine tartrate	Ophthalmic	Solution/Drops 0.15%	Click here
Brinzolamide	Ophthalmic	Suspension/Drops 1%	Click here
Doxorubicin HCl	Injectable	Injection, Liposome	Click here
Ethinyl estradiol/levonorgestrel	Oral	Tablet	Click here
Hydrocodone bitartrate/ibuprofen	Oral	Tablet	Click here
Ketoconazole	Topical	Foam, Aerosol 2%	Click here
Memantine HCl	Oral	Tablet	Click here
Memantine HCl	Oral	Capsule, Extended Release	Click here
Methylprednisolone acetate	Injection	Suspension	Click here
Nebivolol HCl	Oral	Tablet	Click here
Nisoldipine	Oral	Tablet, Extended Release	Click here
Phenytoin sodium	Oral	Capsule, Extended Release	Click here
Phenytoin sodium	Oral	Capsule, Extended Release	Click here
Sevelamer carbonate	Oral	Suspension	Click here
Sevelamer HCl	Oral	Tablet	Click here

The draft guidance documents recommend whatin vivoandin vitrostudies 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 1,236 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 2015 Jan 30]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-generics

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Source: USFDA