FDA releases 52 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 The agency announced on 18 October 2017 that it had released 33 new draft guidance documents and 19 revisions to guidance documents on bioequivalence requirements for the development of generics containing 47 different active ingredients.

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The new draft bioequivalence guidance documents cover generics of Mylan’s anti-allergic reaction injection EpiPen (epinephrine), Novartis’ cancer treatment Afinitor (everolimus) and AstraZeneca’s cancer treatment Lynparza (olaparib), among others, see Table 1.

Revised bioequivalence guidance documents include those for generics of Eli Lilly’s erectile dysfunction drug Cialis (tadalafil), non-steroid anti-inflammatory drugs (NSAIDs) bromfenac and diclofenac, glaucoma treatment brimonidine and antibiotics ciprofloxacin and ofloxacin, as well as various HIV treatments, 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
Azelastine hydrochloride Nasal Spray, Metered Click here
Azithromycin Oral Suspension Click here
Barium sulfate Oral Paste Click here
Betamethasone dipropionate Topical Lotion Click here
Budesonide Rectal Aerosol Foam Click here
Canagliflozin; Metformin HCl Oral Tablet ER Click here
Dantrolene sodium Intravenous Suspension Click here
Dapsone Topical Gel Click here
Deflazacort Oral Suspension Click here
Deflazacort Oral Tablet Click here
Docosanol Topical Cream Click here
Empagliflozin; Metformin HCl Oral Tablet ER Click here
Epinephrine Intramuscular/ subcutaneous Injectable Click here
Erythromycin Topical Gel Click here
Everolimus Oral Tablet for suspension Click here
Fluorometholone Ophthlamic Drops, Suspension Click here
Fluticasone propionate Inhalation Powder Click here
Hydrocortisone acetate Rectal Aerosol, metered Click here
Ivermectin Topical Cream Click here
Levorphanol tartrate Oral Tablet Click here
Lisdexamfetamine dimesylate Oral Tablet, chewable Click here
Methylphenidate HCl Oral Tablet ER Click here
Mometasone furoate Inhalation Powder Click here
Nitisinone Oral Capsule Click here
Olaparib Oral Capsule Click here
Osimertinib mesylate Oral Tablet Click here
Permethrin Topical Cream Click here
Pirfenidone Oral Tablet Click here
Salmeterol xinafoate Inhalation Powder Click here
Telotristat etiprate Oral Tablet Click here
Terbutaline sulfate Oral Tablet Click here
Tiotropium bromide Inhalation Powder Click here
ER: extended release; FDA: US Food and Drug Administration; HCI: hydrochloride.

Table 2: FDA revised draft bioequivalence guidance documents

Active ingredient Route of administration Dosage form Link
Brimonidine tartrate Ophthalmic Solution/ drops 0.2% Click here
Brimonidine tartrate Ophthalmic Solution/ drops 0.1% Click here
Bromfenac sodium Ophthalmic Solution/ drops Click here
Ciprofloxacin HCl Ophthalmic Solution/ drops Click here
Cobicistat/ elvitegravir/ emtricitabine/ tenofovir alafenamide fumarate Oral Tablet Click here
Dapsone Topical Gel, 5% Click here
Diclofenac sodium Ophthalmic Solution/ drops Click here
Emtricitabine/ rilpivirine hydrochloride/ tenofovir alafenamide fumarate Oral Tablet Click here
Emtricitabine/ tenofovir alafenamide fumarate Oral Tablet Click here
Esomeprazole magnesium Oral Tablet DR Click here
Lisdexamfetamine dimesylate Oral Capsule Click here
Mesalamine Oral Tablet DR Click here
Mycophenolate mofetil Oral Suspension Click here
Ofloxacin Ophthalmic Solution/ drops Click here
Olopatadine HCl Ophthalmic Solution/ drops 0.2% Click here
Olopatadine HCl Ophthalmic Solution/ drops 0.1% Click here
Ropinirole HCl Oral Tablet ER Click here
Sucralfate Oral Suspension Click here
Tadalafil Oral Tablet Click here
DR: delayed release; ER: extended release; FDA: US Food and Drug Administration; HCI: hydrochloride.

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 Nov 3]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-generics

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Source: US FDA

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