Academic journal article Bulletin of the World Health Organization

WHO Removes 3 More AIDS Drugs from Approved List

Academic journal article Bulletin of the World Health Organization

WHO Removes 3 More AIDS Drugs from Approved List

Article excerpt

WHO withdrew three more generic drugs from its list of approved AIDS medicines in August after an inspection showed that bioequivalence studies, which demonstrate whether the product has the same therapeutic benefit as the patented original, had not been carried out correctly.

Two other antiretroviral (ARV) medicines were de-listed in May for the same reason, pending new bioequivalence studies.

WHO said the de-listed drugs fulfilled all other requirements on quality, specifications for active ingredients, impurity profile and manufacturing but said lack of bioequivalence could mean the generic copies are not as effective as their patented equivalents.

Peter Graaff from WHO's AIDS Medicines and Diagnostics Service said that switching from the de-listed medicines to alternative products that have not been registered in a country with a strict regulatory system could be risky.

"Although we are not 100% sure yet whether these drugs are bioequivalent--at least we know they are of good quality and safe," said Mr Graaff, referring to the de-listed drugs.

The suspension of the five AIDS medicines could slow efforts to get lifesaving ARV treatment to millions of people in the world's poorest countries, while the new bioequivalence studies get underway.

The procurement of cheap generic copies of patented drugs that fulfil quality, safety and efficacy requirements is central to global efforts to scale up treatment for millions of MDS patients in developing countries. …

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