FDA releases 48 new and revised bioequivalence guidelines for generics

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Sign up
eng / esp

FDA releases 48 new and revised bioequivalence guidelines for generics

Home/Guidelines | Posted 21/08/2015 0 Post your comment

The US Food and Drug Administration (FDA) has released 44 new draft guidance documents and four revisions to guidance documents on bioequivalence requirements for the development of generics containing 46 different active ingredients.

The new draft bioequivalence guidance documents cover generics of HIV medicines Triumeq (abacavir/dolutegravir/lamivudine) and Tivicay (dolutegravir), pain killer aspirin, asthma treatment DuoResp Spiromax (budesonide/formoterol fumarate dihydrate) and acid relux treatment Nexium (omeprazole), among others, see Table 1.

Revised bioequivalence guidance documents include those for generics of high cholesterol treatment Questran (cholestyramine), acne treatment Doryx (doxycycline), angina treatment Efient (prasugrel) and anti-convulsive medication Gabitril (tiagabine), see Table 2.

Table 1: FDA new draft bioequivalence guidance documents

Active ingredient	Route of administration	Dosage form	Link
Abacavir sulfate/dolutegravir/ lamivudine	Oral	Tablet	Click here
Afatinib	Oral	Tablet	Click here
Alendronate	Oral	Effervescent tablet	Click here
Aspirin	Oral	Capsule	Click here
Azelastine/fluticasone propionate	Nasal	Metered spray	Click here
Budesonide/formoterol	Inhalation	Metered aerosol	Click here
Calcium carbonate/ famotidine/ magnesium hydroxide	Oral	Chewable tablet	Click here
Canagliflozin/ metformin	Oral	Tablet	Click here
Cyclophosphamide	Oral	Capsule	Click here
Cyproheptadine	Oral	Tablet	Click here
Dabrafenib	Oral	Capsule	Click here
Dapagliflozin propanediol	Oral	Tablet	Click here
Dexbrompheniramine maleate/ pseudoephedrine sulphate	Oral	Capsule	Click here
Dolutegravir	Oral	Tablet	Click here
Donepezil/memantine	Oral	ER tablet	Click here
Doxycycline	Oral	Tablet	Click here
Droxidopa	Oral	Capsule	Click here
Eliglustat	Oral	Capsule	Click here
Empagliflozin	Oral	Tablet	Click here
Emtricitabine/tenofovir	Oral	Tablet	Click here
Enzalutamide	Oral	Capsule	Click here
Fentanyl	Sublingual	Spray	Click here
Indomethacin	Oral	Capsule	Click here
Lanthanum carbonate	Oral	Powder	Click here
Levalbuterol tartrate	Inhalation	Metered aerosol	Click here
Levomilnacipran	Oral	ER capsule	Click here
Macitentan	Oral	Tablet	Click here
Methazolamide	Oral	Tablet	Click here
Miglitol	Oral	Tablet	Click here
Naloxegol oxalate	Oral	Tablet	Click here
Naproxen sodium	Oral	Capsule	Click here
Nitroglycerin	Transdermal	Ointment	Click here
Omeprazole	Oral	Powder suspension	Click here
Oxybutynin	Transdermal	ER film	Click here
Oxybutynin	Transdermal	Metered gel	Click here
Oxycodone	Oral	Capsule	Click here
Primaquine	Oral	Tablet	Click here
Sildenafil	Oral	Suspension	Click here
Simeprevir	Oral	Capsule	Click here
Sofosbuvir	Oral	Tablet	Click here
Tolcapone	Oral	Tablet	Click here
Vemurafenib	Oral	Tablet	Click here
Vismodegib	Oral	Capsule	Click here
Vortioxetine hydrobromide	Oral	Tablet	Click here

ER: extended release; FDA: US Food and Drug Administration.

Table 2: FDA revised draft bioequivalence guidance documents

Active ingredient	Route of administration	Dosage form	Link
Cholestyramine	Oral	Powder	Click here
Doxycycline hyclate	Oral	DR tablet	Click here
Prasugrel	Oral	Tablet	Click here
Tiagabine	Oral	Tablet	Click here

DR: delayed release; FDA: US Food and Drug Administration.

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 time points and analytes to be measured in blood samples are also detailed in the draft guidance documents.

In total the FDA now has 1,321 product-specific guidelines with bioequivalence study recommendations. The agency also has an overarching guidance document on bioequivalence recommendations for specific products [1].

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.

FDA publishes guidance on ANDAs for new strengths

FDA issues draft guidance for biosimilar meetings

Reference
1. GaBI Online - Generics and Biosimilars Initiative. US guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 21]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-generics

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: US FDA