Gilead to launch generic versions of its hep C drugs
Gilead is set to produce cheaper authorised generic (AG) versions of its branded hepatitis C treatments from 2019.
The decision comes amid a number of patent challenges against Gilead’s drugs.
Gilead announced on Monday, September 24, that it would be launching AG versions of its hepatitis C medications in the US through a newly created subsidiary, Asegua Therapeutics.
AG versions of Epclusa (sofosbuvir 400mg/velpatasvir 100mg) and Harvoni (ledipasvir 90mg/sofosbuvir 400mg) will have a list price of $24,000 for the most common course of therapy in January 2019, according to Gilead.
Since the 2013 launch of Gilead’s first hepatitis C medication, the average price paid for each bottle in the US has decreased by more than 60%, the release said, but “complexities” of the US healthcare system mean that these discounts do not always reach patients.
As reported by Bloomberg on Monday, September 24, Gilead’s branded hepatitis C drugs sparked widespread debate about the cost of pharmaceuticals in the US, as they were introduced at a price of more than $1,000 per pill.
Gilead said that its new AGs are priced to reflect the discounts that health insurers and government payers receive, and insurers will be offered the choice of supplying the branded medications or AGs.
John Milligan, president and CEO of Gilead, said that the launch of the AGss is the best way to introduce a lower-priced alternative to its branded hepatitis C medications without causing disruption to the healthcare system.
He added that Gilead is committed to enabling price reductions and increasing transparency.
The news comes amid a number of disputes surrounding Gilead’s various hepatitis C treatments.
For example, the validity of a number of Gilead’s hepatitis C drugs has been challenged by non-profit group Médecins Sans Frontières (MSF), in Europe and China. Meanwhile, in India, the Initiative for Medicines, Access & Knowledge opposed a patent for Gilead’s drug Sovaldi (sofosbuvir), and publicly backed the opposition.
And Gilead’s hepatitis C drugs have been targeted for infringement, with pharmaceutical company Merck claiming that Harvoni and Sovaldi infringed its US patents.
In 2016, the US District Court for the Northern District of California initially awarded Merck $200 million in damages for the infringement. However, earlier this year, the US Court of Appeals for the Federal Circuit upheld the California court’s later determination that Merck had engaged in misconduct and could not bring an action against Gilead.
The $200 million verdict was overturned and Merck ordered to pay the costs.
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