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Thailand's FDA Registers Generic of Abbott's Aluvia Under Compulsory Licensing Program
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Generic Aids medicine from India wins nod
Bangkok Post Oct 17, 2007
The Food and Drug Administration has approved the registration of the second-line Aids drug lopinavir/ritonavir for use under the compulsory licensing policy.
FDA secretary general Siriwat Thiptaradol yesterday said the drug has passed the registration process which took more than three months to complete.
The newly-approved medicine is a generic version of Aluvia, a heat-stable form of second-line Aids drug Kaletra. Both Aluvia and Kaletra are produced by the US-based Abbot Laboratories.
The government in January announced the compulsory licensing policy to bypass patents of the original versions of the second-line Aids drugs.
However, the drugs' patent holder, Abbot Laboratories, opposed the move and offered to cut the price of Kaletra to $1,000 (32,500 baht) per patient per year on a condition that the Public Health Ministry revoke its CL policy.
The ministry rejected the offer, prompting Abbot to freeze registration of Aluvia in Thailand.
GPO board chairman Vichai Chokewiwat said the agency would soon import the first lot of lopinavir/ritonavir from India's generic drug maker Matrix Laboratories.
The amount would be enough for 8,000 HIV-positive people for the next six months.
The price quoted by the Indian drugmaker was at 24,324 baht (US$695) per person per year (2,027 baht per person per month).
Meanwhile, leading cancer drug producers Novartis, Roche Laboratories and Sanofi Aventis will meet the government's price negotiation panel, led by Dr Siriwat, tomorrow to discuss the possibility of a price reduction.
The talks would be the first between the government and the world's leading cancer drug makers after the National Health Security Office last month asked the Public Health Ministry to consider overriding the patents of four cancer drugs _ imatinib, letrozole, docetaxel, and erlotinib _ as their prices were considered too high.
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