Gilead to launch authorised generic versions of hepatitis C drugs Epclusa, Harvoni next year in US

Gilead Sciences announced Monday that it plans to launch authorised generic versions of its hepatitis C therapies Epclusa (sofosbuvir/velpatasvir) and Harvoni (ledipasvir/sofosbuvir) in the US next year. CEO John Milligan noted that the "unusual decision" comes "more than a decade before the expiration of the patents" on the products. 

Milligan explained that the launch of the authorised generics "is 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." Gilead noted that the authorised generics will have a list price of $24 000 for the most common course of treatment, representing a reduction of $50 760 off the list price of Epclusa.

Gilead noted that the price of the authorised generics are set to more closely reflect the price health insurers and government will pay after discounts and rebates today for the company's branded HCV medicine, adding that insurers will have the choice of offering either the authorised generics or the branded medications for both Epclusa and Harvoni. According to the company, in the Medicare Part D setting, the authorised generics could save patients up to $2500 in out-of-pocket costs per course of therapy.

The drugmaker said that authorised generics will launch in January 2019 through a newly created subsidiary, Asegua Therapeutics. "We are committed to working with key participants in the healthcare system, including insurers, policymakers and government officials, to lower the list prices of Harvoni and Epclusa moving forward," commented Milligan.

Harvoni was initially approved by the FDA in 2014 for the treatment of adults with chronic HCV genotype 1 infection, with its indication later expanded to include HCV genotypes 4, 5 and 6. Meanwhile, Epclusa was authorised in 2016 for adults with genotype 1-6 HCV infection.

The news comes after Gilead withdrew key patent claims in China protecting sofosbuvir, which the drugmaker markets as Sovaldi, following a challenge by the Initiative for Medicines, Access & Knowledge (I-MAK). India's patent controller rebuffed Gilead's filing seeking a patent for the drug after Natco Pharma and I-MAK contested the application. I-MAK has additionally urged the US Patent Trial and Appeal Board to invalidate patents covering the therapy.

In 2014, Gilead signed a deal allowing seven companies to distribute Sovaldi in 91 developing countries.

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