Urgent need to make linezolid available in South Africa at affordable price

In December 2015 TB advocates sent open letters to a number of pharmaceutical companies – Glenmark, Hetero, Sanofi, Macleods, Pfizer, Teva, Alkem, Amneal and Apotex – regarding registration and pricing of linezolid in South Africa and other high-burden TB countries in the region. The letters demand that the pharmaceutical companies register their linezolid products in South Africa, and subsequently offer them at a price in line with that of Hetero's generic currently offered through the Global Drug Facility. Hetero, Sanofi and Pfizer, which already have their linezolid products registered in South Africa, are urged to immediately reduce the price of linezolid in South Africa, and instead offer the drug at a price in line with that of the lowest global prices of quality-assured products.

The signatories to the letters support the registration of multiple quality-assured sources of linezolid in South Africa, in order to address high prices that currently prevent linezolid from being offered to all patients with drug-resistant tuberculosis (DR-TB) who could benefit from its use. Additionally, clinicians, health care workers, patients, and civil society organizations called twice on South African Medicines Control Council to prioritize rapid registration of quality-assured generic linezolid.

Linezolid is one of the key companion drugs to the new DR-TB drugs that are being scaled up in South Africa. Yet linezolid remains one of the most expensive drugs within a DR-TB regimen, and a daily dose costs approximately double that of bedaquiline in South Africa. Registration of quality-assured versions of generic linezolid and their entry into the South African market at an affordable price could facilitate greater access to more robust DR-TB regimens and contribute to reducing DR-TB morbidity and mortality. Greater access to treatment is a crucial component in curbing the spread of the disease and limiting the development of further drug resistance.

“Clinicians and patients can no longer wait for more affordable linezolid for DR-TB regimens.”

To download the open letters, click on the links below:

• Open letter to Glenmark regarding registration and pricing of linezolid in South Africa (December 14, 2015)
• Open letter to Hetero and Sanofi regarding pricing of linezolid in South Africa (December 14, 2015)
• Open letter to Macleods regarding registration and pricing of linezolid in South Africa (December 14, 2015)
• Open letter to Pfizer regarding pricing and availability of linezolid in South Africa (December 14, 2015)
• Open letter to Teva regarding registration and pricing of linezolid in South Africa (December 14, 2015)
• Open letter to Alkem regarding registration and pricing of linezolid in South Africa (December 17, 2015)
• Open letter to Amneal regarding registration and pricing of linezolid in South Africa (December 17, 2015)
• Open letter to Apotex regarding registration and pricing of linezolid in South Africa (December 17, 2015)