WHO pulls two generic AIDS drugs from approved list
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《英国医生杂志》
In a move that could dent confidence in the generic drugs industry, the World Health Organization (WHO) withdrew two anti-AIDS drugs, lamivudine and zidovudine, from its list of approved medicines after laboratory tests failed to prove they have the same chemical make up as their patented equivalents, Epivir and Retrovir, both made by GlaxoSmithKline.
The WHO said that withdrawing the 150 mg lamivudine and 300mg zidovudine tablets, contained in blister packs of 10 tablets, from the WHO抯 recommended list was not the same as pulling a drug from the market. It stressed that the two drugs—which are vital in the fight against AIDS in poor countries—still comply with quality standards, in terms of specifications for active pharmaceutical ingredients, impurity profile, formulation, and manufacturing.
However, it said their withdrawal on 27 May from the WHO抯 list of "pre-qualified" or recommended medicines was necessary because of a lack of proof of bioequivalence. "The drugs may turn out to be bioequivalent, but we don抰 know until this has been proved," said Andre Van Zyl, WHO project manager for pre-qualification of HIV/AIDS drugs.
The WHO抯 move is certain to fuel the pharmaceutical industry抯 highly vocal opposition to generic drugs makers, whose products (especially anti-AIDS drugs) they have often criticised for failing to attain international standards.
But campaigners at the French non-governmental organisation Médicins Sans Frontières, who started distributing the two generic antiretroviral drugs in Africa a few years before they appeared on the WHO recommended lists, said they had always found the two products to be safe and effective and would continue using them.
The WHO said that, since the drugs?quality was not at issue, it was recommending use of an equivalent alternative until bioequivalence is proved and if not, then continued use of the two drugs. It is up to individual member countries to decide whether to follow WHO advice.
The WHO requires laboratory proof of bioequivalence for products it recommends for serious conditions such as AIDS, malaria, and tuberculosis. But some member countries do not require bioequivalence for copies of patented drugs.
The WHO said it could not have spotted the problem when Indian generics company Cipla first provided the WHO with data and information on the two drugs. During subsequent spot checks, WHO experts found that the data and information—which had been compiled for Cipla by a contract research organisation—were not up to WHO standards.
Cipla said last week that it had commissioned another contract research organisation to do the same job, and it would report on bioequivalence by the end of July.(Geneva Fiona Fleck)
The WHO said that withdrawing the 150 mg lamivudine and 300mg zidovudine tablets, contained in blister packs of 10 tablets, from the WHO抯 recommended list was not the same as pulling a drug from the market. It stressed that the two drugs—which are vital in the fight against AIDS in poor countries—still comply with quality standards, in terms of specifications for active pharmaceutical ingredients, impurity profile, formulation, and manufacturing.
However, it said their withdrawal on 27 May from the WHO抯 list of "pre-qualified" or recommended medicines was necessary because of a lack of proof of bioequivalence. "The drugs may turn out to be bioequivalent, but we don抰 know until this has been proved," said Andre Van Zyl, WHO project manager for pre-qualification of HIV/AIDS drugs.
The WHO抯 move is certain to fuel the pharmaceutical industry抯 highly vocal opposition to generic drugs makers, whose products (especially anti-AIDS drugs) they have often criticised for failing to attain international standards.
But campaigners at the French non-governmental organisation Médicins Sans Frontières, who started distributing the two generic antiretroviral drugs in Africa a few years before they appeared on the WHO recommended lists, said they had always found the two products to be safe and effective and would continue using them.
The WHO said that, since the drugs?quality was not at issue, it was recommending use of an equivalent alternative until bioequivalence is proved and if not, then continued use of the two drugs. It is up to individual member countries to decide whether to follow WHO advice.
The WHO requires laboratory proof of bioequivalence for products it recommends for serious conditions such as AIDS, malaria, and tuberculosis. But some member countries do not require bioequivalence for copies of patented drugs.
The WHO said it could not have spotted the problem when Indian generics company Cipla first provided the WHO with data and information on the two drugs. During subsequent spot checks, WHO experts found that the data and information—which had been compiled for Cipla by a contract research organisation—were not up to WHO standards.
Cipla said last week that it had commissioned another contract research organisation to do the same job, and it would report on bioequivalence by the end of July.(Geneva Fiona Fleck)