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 The agency announced on 15 May 2017 that it had released 21 new draft guidance documents and 16 revisions to guidance documents on bioequivalence requirements for the development of generics containing 33 different active ingredients.

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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.

Related article
Doctors in the US should remember to prescribe generics

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

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