An ‘unusual decision’: Gilead to launch hep C generics ten years early

Gilead Sciences, Inc. has announced plans to release its own authorised generic versions of Epclusa (sofosbuvir 400mg/velpatasvir 100mg) and Harvoni ​(ledipasvir 90mg/sofosbuvir 400mg).

The medicines, indicated for the treatment of chronic hepatitis C (HCV), will be marketed by a Gilead subsidiary, to be known as Asegua Therapeutics, from January 2019 at a list price of $24,000 (€20,500) for the most common therapy.

The generic alternatives could offer certain patients with Medicare plans a $2,500 reduction in out-of-pocket costs per treatment. It will also be a welcome reprieve for Harvoni patients not covered by insurance, who faced a $1,150 price tag per pill when the combination drug launched in 2014​.

According to Gilead, the decision to market generic versions in the US more than ten years before their patents expire reflects, in part, an often ambiguous and complex US drug supply chain.

“In the US, the price paid for Gilead’s HCV medicines by commercial and government health insurers after discounts and rebates have been applied is substantially lower than the list price,”​ a Gilead spokesperson explained.

“However these discounts may not always translate into lower out-of-pocket medication costs for patients. The authorised generics will serve as a bridge to longer-term solutions aimed at reducing out-of-pocket medication costs for people living in the US,”​ we were told.

According​ to CEO John Milligan, the “unusual decision” ​to launch authorised generics represents “the best solution available to us today to quickly introduce a lower-priced alternative to our HCV medications without significant disruption to the healthcare system and our business.” ​

In Europe this month​, humanitarian not-for-profit Médecins du Monde, alongside organisations from 17 countries, criticised Gilead for maintaining a patent related to a component of HCV drug ingredient sofosbuvir – claiming it prevents patients from receiving affordable treatment.

Despite allegations the component in question is “inactive” ​and its patent, “unmerited”, ​the European Patent Office decided to uphold its protection.