A generic version of atazanavir, manufactured by the Indian company Emcure Pharmaceuticals, has received tentative approval from the US Food Drug Administration, it was announced last week.
Tentative approval means that although the generic version cannot be sold in the United States, it can be purchased by treatment programmes supported by the US President’s Emergency Plan for AIDS Relief (PEPFAR).
FDA approval also means that the product can automatically receive WHO pre-qualification.
The originator version of atazanavir, marketed as Reyataz, is manufactured by Bristol Myers Squibb. The company issued voluntary licenses to manufacture generic versions of the drug to two companies, Emcure Pharmaceuticals and Aspen Pharmacare, in February 2006.
Atazanavir, boosted with ritonavir, is one of the products designated as a priority drug for use in second-line therapy by a World Health Organization advisory group. Although the recommendation doesn’t have the force of an official WHO treatment guideline, the advice is designed to send a signal to national treatment programmes and drug manufacturers. Atazanavir is potentially cheaper than lopinavir/ritonavir, marketed in developing countries as Aluvia, and a growth in demand for the product may drive down the price.
However, with only one current generic supplier, price reduction is not inevitable, and it will be up to purchasers to negotiate lower costs.
The bulk of generically manufactured atazanavir will be purchased by UNITAID, the international drug purchase fund for second-line HIV drugs, which is financed by a levy on airline travel by 27 countries. The fund is already supporting second-line treatment for 56,000 people in 20 countries, and has committed to expand second-line treatment to a further 60,000 people.