India's Natco Pharma said that it has received Indian regulatory approval to locally sell its generic version of Sovaldi, the hepatitis C treatment that costs $1,000 a day in the U.S., making it the first Indian license holder to do so and allowing it to set a bar on pricing in India and onto emerging markets.
Gilead Sciences ($GILD) has come under strong criticism for charging high prices on Sovaldi and a combination pill, Harvoni. In response, Gilead reached an agreement last September with originally eight India-based generics companies to offer generic versions of the drug at a lower price in India and 90 other nations, which together would cover 54% of the world's HCV patients. The agreements also covered Harvoni, which combines sofosbuvir with ledipasvir.
The companies: Biocon, Cadila Healthcare, Cipla, Hetero Labs, Mylan Laboratories ($MYL), Ranbaxy Laboratories, Sequent Scientific and Strides Arcolab, came as Natco had challenged the company's patent in India even as it too was given a license to sell copies of the drug.
On Friday, Hetero Pharma was also cleared to market a generic Sovaldi and said it would launch by the end of the month at home and in other countries. Natco and Hetero announced a price in India of $318 for a bottle of 28 tablets, or just over $11 a pill. Both are for 400 mg doses. Natco also said it expects to launch its version, which it labeled Hepcinat, "very soon" through partnerships with other India drug makers, but set no date.
Both companies are among the now 10 in India to sign non-exclusive licensing deals with Gilead after it lost its local patent for the drug. In addition, Natco said it would take advantage of the fact Gilead had no patent in those countries to sell its version in Bangladesh and Nepal.
Gilead said, "Sofosbuvir recently received regulatory approval in India (January 2015), and regulatory submissions have been completed in additional countries, including Pakistan, Thailand, Brazil, Uganda, South Africa and Nigeria." The 8 generics makers, free to set their own prices, would still be competing against Gilead and the brand. The company recently negotiated lower prices with Germany's regulators.
- here's the Natco release