Statement |

First generic source for DR-TB drug linezolid eligible for procurement

Geneva, 18 June 2013 — The first affordable generic version of linezolid (600mg tablet), a drug used to treat drug-resistant tuberculosis (DR-TB), has been reviewed by the Global Fund Expert Review Panel*, and is now eligible for procurement under Global Fund grants to treat DR-TB.  For parties interested in procuring the Hetero product outside of the Global Fund mechanism, the Expert Review Panel’s assessment provides an added level of quality assurance for the product.

This is a significant development, as the high cost of the originator product from Pfizer meant the drug remained out of reach for many DR-TB patients across the developing world. For example, in South Africa, a country with a high burden of drug-resistant tuberculosis, Pfizer’s linezolid is available in the private sector at a price of US$71 per tablet. This means that actors like MSF pay around $13,000 per patient for six months of treatment in South Africa.

Indian generic company Hetero is now offering linezolid at $2.50 per tablet ex works, which equates to approximately $450 for six months of treatment – a reduction more than 90% from the Pfizer market price.

For more information on sources and prices for drug-resistant TB medicines, please see Médecins Sans Frontières’ 2012 report, DR-TB Drugs Under the Microscope.

* The Global Fund’s Expert Review Panel (ERP) is an independent technical body composed of external technical experts, hosted by the WHO Department of Essential Medicines and Pharmaceutical Policies. Their purpose is to review the potential quality risk of using antiretroviral, anti-TB and antimalarial products which are not yet WHO-prequalified or authorised by a stringent regulatory authority, and to give advice to the Global Fund and the Global Drug Facility whether procurement of such products can be authorised.