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FDA releases 37 new and revised bioequivalence guidelines for generics

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As part of its ongoing efforts to provide product-specific guidance for generics makers the US Food and Drug Administration (FDA) has again released several new and revised bioequivalence documents. The agency announced on 15 May 2017 that it had released 21 new draft guidance documents and 16 revisions to guidance documents on bioequivalence requirements for the development of generics containing 33 different active ingredients.

The new draft bioequivalence guidance documents cover generics of attention deficit hyperactivity disorder (ADHD) treatment amphetamine, antibiotic gentamicin, hepatitis C treatment sofosbuvir; velpatasvir and chronic lymphocytic leukaemia treatment venetoclax, among others, see Table 1.

Revised bioequivalence guidance documents include those for generics of anticoagulant apixaban, cancer treatment bexarotene, HIV treatment emtricitabine/tenofovir and multiple sclerosis treatment Gilenya (fingolimod), among others, see Table 2.

FDA bioequivalence requirements demand that the generic drug performs in the same way in the body and has the same active ingredient(s), strength, dosage form and route of administration as the brand-name reference drug.

Table 1: FDA new draft bioequivalence guidance documents

Active ingredient	Route of administration	Dosage form	Link
Acetylcysteine	Oral	Tablet, effervescent	Click here
Amphetamine	Oral	Tablet, ER, OD	Click here
Aprepitant	Oral	Suspension	Click here
Azelastine hydrochloride	Nasal	Spray, metered	Click here
Bisacodyl/ polyethylene glycol 3350/ potassium chloride/ sodium bicarbonate/ sodium chloride	Oral	Tablet DR for solution	Click here
Carbidopa/ levodopa	Enteral	Suspension	Click here
Chlordiazepoxide hydrochloride/ clidinium bromide	Oral	Capsule	Click here
Clonazepam	Oral	Tablet, OD	Click here
Edoxaban tosylate	Oral	Tablet	Click here
Gentamicin sulfate	Topical	Ointment	Click here
Hydrocortisone butyrate	Topical	Lotion	Click here
Hydrocortisone	Topical	Cream	Click here
Linagliptin/ metformin hydrochloride	Oral	Tablet, ER	Click here
Lorcaserin HCl	Oral	Tablet, ER	Click here
Methylnaltrexone bromide	Oral	Tablet	Click here
Nitroglycerin	Sublingual	Powder	Click here
Nystatin/ triamcinolone acetonide	Topical	Cream	Click here
Nystatin/ triamcinolone acetonide	Topical	Ointment	Click here
Tetracaine hydrochloride/ oxymetazoline hydrochloride	Nasal	Spray	Click here
Sofosbuvir/ velpatasvir	Oral	Tablet	Click here
Venetoclax	Oral	Tablet	Click here
DR: delayed release; ER: extended release; OD: orally disintegrating.

Table 2: FDA revised draft bioequivalence guidance documents

Active ingredient	Route of administration	Dosage form	Link
Acamprosate Calcium	Oral	Tablet, DR	Click here
Apixaban	Oral	Tablet	Click here
Bexarotene	Oral	Capsule	Click here
Calcium acetate	Oral	Tablet	Click here
Calcium acetate	Oral	Capsule	Click here
Deferiprone	Oral	Tablet	Click here
Dolutegravir sodium	Oral	Tablet	Click here
Emtricitabine/ tenofovir disoproxil fumarate	Oral	Tablet	Click here
Fingolimod	Oral	Capsule	Click here
Lanthanum Carbonate	Oral	Tablet, chewable	Click here
Nevirapine	Oral	Tablet	Click here
Phenytoin	Oral	Tablet, chewable	Click here
Phenytoin	Oral	Suspension	Click here
Propafenone HCl	Oral	Capsule, ER	Click here
Trospium chloride	Oral	Capsule, ER	Click here
Trospium chloride	Oral	Tablet	Click here
DR: delayed release; ER: extended release.

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. Some of the documents also provide discussion on data formats.

FDA also has an overarching guidance document on bioequivalence recommendations for specific products [1], as well as a dissolution methods database.

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, USA.

Reference
1. GaBI Online - Generics and Biosimilars Initiative. US guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jul 14]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-generics

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Source: US FDA