Gilead Sciences ($GILD) has confirmed an Economic Times report that several Indian drugmakers have licenses to manufacture its cutting-edge hepatitis Epclusa (sofosbuvir and velpatasvir), possibly setting off a price war for earlier therapies made for developing markets.
The Economic Times quoted a Gilead spokesman as confirming an earlier report by the newspaper on Epclusa.
"A technology transfer has been completed, and now, with (U.S.) FDA approval, these manufacturers are beginning production and distribution of generic low-cost versions of this medicine, setting whatever prices they wish," Nick Francis, Gilead spokesman, said in an email to the newspaper.
Francis added that for the branded version, Gilead is currently finalizing its own pricing for developing countries. "In India, we are required to conduct a clinical trial in order for the medicine to be submitted for regulatory approval. This trial is currently enrolling. We are discussing how a regulatory submission could be expedited," Francis said.
Even though it was not approved at the time, Epclusa falls under a 2014 pact that led to Gilead issuing licenses to India-based manufacturers to make and/or market hep C treatments at sharply lower prices in around 100 developing countries, though excluding some countries such as China and Russia.
The availability of the drug has raised questions about the status of related therapies under the pact, with one analyst speculating a sharp price cut.
"With so many generic players, the prices have drastically come down, however, companies might delay the launch of Epclusa as they might want to get rid of their stocks of the older drugs", Mandar Kubal, director of Mumbai-based Infectious Diseases & Pulmonary Care, told the newspaper.
Earlier this month, Dhaka-based Beacon Pharmaceuticals made the first generic copy Epclusa (sofosbuvir/velpatasvir), aiming for a price point said to be one-tenth of the originator, the Economic Times reports.
Monjul Alam, senior vice-president of the company, told the newspaper the generic is called Sofosvel. The company is outside of an access manufacturing license pact Gilead has for developing nations.
- here's the story from the Economic Times