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 The agency announced on 18 October 2017 that it had released 33 new draft guidance documents and 19 revisions to guidance documents on bioequivalence requirements for the development of generics containing 47 different active ingredients.

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