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FDA releases 37 new and revised bioequivalence guidelines for generics Posted 14/07/2017

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 The agency announced on 15 May 2017 that it had released 21 new draft guidance documents and 16 revisions to guidance documents on bioequivalence requirements for the development of generics containing 33 different active ingredients.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

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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 2017 Jul 14]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-generics

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Source: US FDA

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