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On 12 December 2014, the US Food and Drug Administration (FDA) released 31 new draft guidance documents and 22 revisions to guidance documents on bioequivalence requirements for the development of generics containing 42 different active ingredients.

Guidance V13F21

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

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