Indian company launches generic version of abacavir

5 February 2003

Estimated reading time 2 minutes

The Indian pharmaceutical manufacturer Ranbaxy yesterday launched its generic version of abacavir, trade named Virol. The drug will cost around 6,500 rupees a month (£85/$142).

Ranbaxy says that Virol is bioequivalent to Glaxo Smith Kline’s Ziagen, the originator brand, although World Health Organisation review has not yet been carried out. Three Ranbaxy products – zidovudine, nevirapine and zidovudine/lamivudine combination tablets – have already been approved as bioequivalent by WHO and appear on its pre-qualified antiretrovirals list.

Initially Virol will only be available in India, but Ranbaxy will be keen to see Virol adopted as the preferred form of abacavir used by antiretroviral access programmes in resource-limited countries. Abacavir is recommended as a preferred element of first-line therapy due to its ease of dosing (one 300mg tablet twice daily, no food restrictions), and because of its lack of interaction with anti-TB medications.

Glossary

first-line therapy

The regimen used when starting treatment for the first time.

drug interaction

A risky combination of drugs, when drug A interferes with the functioning of drug B. Blood levels of the drug may be lowered or raised, potentially interfering with effectiveness or making side-effects worse. Also known as a drug-drug interaction.

generic

In relation to medicines, a drug manufactured and sold without a brand name, in situations where the original manufacturer’s patent has expired or is not enforced. Generic drugs contain the same active ingredients as branded drugs, and have comparable strength, safety, efficacy and quality.

malaria

A serious disease caused by a parasite that commonly infects a certain type of mosquito which feeds on humans. People who get malaria are typically very sick with high fevers, shaking chills, and flu-like illness.

However, Virol is likely to be considered less convenient than Trizivir, Glaxo Smith Kline’s coformulation of zidovudine, lamivudine and abacavir, which can be dosed as one tablet twice a day. GSK is currently offering Trizivir at a price of $1624 a year to least developed countries and all African states, as well as all projects fully financed by the Global Fund to Fight AIDS. TB and Malaria. GSK’s Ziagen is offered on the same basis at $986 a year.

In comparison Virol would cost $1704 a year if it were offered to least-developed countries at the domestic price.

Further information

Ranbaxy press release