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Regulatory Focus™ > News Articles > FDA Releases Dozens of New Bioequivalence Recommendations, Including for Sovaldi

FDA Releases Dozens of New Bioequivalence Recommendations, Including for Sovaldi

Posted 29 June 2015 | By Alexander Gaffney, RAC

FDA Releases Dozens of New Bioequivalence Recommendations, Including for Sovaldi

A new batch of bioequivalence recommendations issued by the US Food and Drug Administration (FDA) aims to make it easier for generic drug manufacturers to eventually make copies of several popular drugs, including Sovaldi (sofosbuvir), Northera (droxidopa), Xtandi (enzalutamide) and Olysio (simeprevir).


Bioequivalence recommendations are a critical part of the submission of an Abbreviated New Drug Application (ANDA)—the application generic drug companies submit for each new generic drug.

Generic drugs, unlike new drugs, may be approved by FDA by showing that they are (among other things) bioequivalent to the drug they intend to reference. Bioequivalence can be shown in relatively small trials involving human subjects, which permits a company to avoid much larger—and much more expensive—full clinical trials required of new drug substances.

While generic drug companies can conduct their own bioequivalence testing, FDA often releases "bioequivalence recommendations" establishing recommended testing protocols for specific generic drug formulations. Each document contains a list of recommended studies (typically at least two), the characteristics of each study, the standard for bioequivalence that must be met by each generic product and potential waivers a generic company may apply for.

The documents are, in effect, a roadmap for regulatory approval for generic drug companies. The publication of a bioequivalence document does not, however, indicate that FDA will approve a generic drug product immediately. Patent and marketing exclusivity protections may still be in effect, which can preclude FDA approval or market access.

New Guidance

On 29 June 2015, FDA released a new batch of bioequivalence recommendations covering more than three dozen drug products, including several notable branded drug products not yet subject to generic competition.

Perhaps the most notable addition to the list is sofosbuvir, a blockbuster hepatitis C drug better known by its brand name Sovaldi. It is also a primary ingredient in the hepatitis C combination drug, Harvoni. The drug is one of the top-selling drug products in the world by total revenue.

Other notable drugs included on the list include Xtandi, Subsys, Truvada, Jardiance, Invokamet, Zelboraf and Olysio. The full list may be found below:

New Draft Product-Specific BE Recommendations for Drug Products
Generic NameBrand Name
Abacavir sulfate; Dolutegravir sodium; LamivudineTriumeq
Afatinib dimaleateGilotrif
Alendronate sodiumFosamax
Azelastine hydrochloride; Fluticasone propionateDymista
Budesonide; Formoterol fumarate dihydrateSymbicort
Calcium carbonate; Famotidine; Magnesium hydroxidePepcid Complete
Canagliflozin; Metformin hydrochlorideInvokamet
Cyproheptadine hydrochloride 
Dabrafenib mesylateTafinlar
Dapagliflozin propanediolFarxiga
Dexbrompheniramine maleate and Pseudoephedrine sulfateDrixoral
Dolutegravir sodiumTivicay
Donepezil hydrochloride; Memantine hydrochlorideNamzaric
Doxycycline hyclateDoryx
Eliglustat tartrateCerdelga
Emtricitabine; Tenofovir disoproxil fumarateTruvada
Lanthanum carbonateFosrenol
Levalbuterol tartrateXopenex HFA
Levomilnacipran hydrochlorideFetzima
Naloxegol oxalateMovantik
Naproxen sodium 
Omeprazole; Sodium bicarbonateZegerid
OxybutyninDitropan, Gelnique, Oxytrol
Oxycodone hydrochloride 
Primaquine phosphatePrimaquine
Sildenafil citrateRevatio
Simeprevir sodiumOlysio
Vortioxetine hydrobromideBrintellix


In addition, FDA also released several revised bioequivalence recommendations covering existing drug products:

Revised Draft Product-Specific BE Recommendations for Drug Products
Generic NameBrand Name
Doxycycline hyclateDoryx
Prasugrel hydrochlorideEffient
Tiagabine hydrochlorideGabitril


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