Sofosbuvir (Sovaldi), as well known for its effectiveness against hepatitis C as for its extraordinary cost, may soon have a generic form. The deal was made between Gilead and Mylan.
A generic form of Sovaldi, this is what the Mylan laboratory announces on September 15. The generic drug maker has reached an agreement with the US company Gilead Sciences and obtains the non-exclusive rights to manufacture and distribute the active ingredient, sofosbuvir. This treatment for hepatitis C is considered a small revolution in the medical community, but its exorbitant cost is debated.
The agreement is therefore concluded between Mylan and Gilead Sciences. But a major condition is essential: the generic specialist will only be able to market sofosbuvir in 91 developing countries. The announcement remains major despite everything, since the countries in question represent 54% of the population infected with the hepatitis C virus, according to Mylan. “This agreement with Gilead will allow Mylan to provide rapid access to a more affordable version of Sovaldi, which will help meet the medical needs of millions of patients in developing countries who do not have access to this life-saving treatment,” said Mylan CEO Heather Bresch.
A price still unknown
There remains a major unknown: the price of this generic form of the flagship treatment. On this point, Mylan and Gilead do not communicate. Yet it is the nerve of the battle: since its marketing authorization (MA) granted urgently last January, Sovaldi is also known for its impressive results as for its extraordinary cost. A 3-month therapy is 100% effective against the hepatitis C virus … but a single tablet costs $ 1,000 in the United States, when its production requires only 136.
Gilead had announced a few months ago that the prices of the treatment would vary according to the income level of the countries. This agreement could well represent the first step. But at the same time, the price of the new version of the treatment marketed by GileadSciences is expected to rise further, according to Reuters.
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