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9 August 2017Americas

FDA finalises 46 bioequivalence guidelines in August

The US Food and Drug Administration (FDA) finalised 46 product-specific bioequivalence guidances in August.

The guidances outline the FDA’s “current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference-listed drugs”.

According to the Regulatory Affairs Professionals Society, an organisation for those involved with the regulation of healthcare and related products, the finalisations were made on Friday, August 4.

“While the agency has released several batches of new and revised draft bioequivalence guidances since 2016, this is the first time the agency has finalised any bioequivalence guidances since September 2015,” said the society.

Guidance for Gilead's hepatitis B and HIV drug Viread (tenofovir disoproxil fumarate) was included, along with antidepressant drug citalopram and formulations of antibiotic amoxicillin.

The society added that the guidances provide recommendations for the studies that should be done to demonstrate that the generic is bioequivalent, such as what analytes to measure, and what dissolution test methods and sampling times to use.

“Some of the guidances also specify the testing that can be done in order to obtain a waiver for in vivo testing, though for some products, such as valporic acid, FDA says in vivo tests should be done,” explained the society.

In June, the FDA announced that it planned to increase competition in the US market for prescription drugs, as well as facilitate the entry of generic drugs into the market.

The agency published a list of off-patent, branded drugs without approved generics and implemented a new policy to expedite the review of generic drug applications.

Scott Gottlieb, the FDA’s managing director, also said that although the FDA doesn’t have a direct role in drug pricing, it can take steps to help address the problem.

To address the problem, the agency will facilitate “increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines” through its drug competition action plan.

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