Gilead to launch generics of its hepatitis C virus treatments via new subsidiary

By PharmaCompass

2018-09-27

Impressions: 106 Article

How do companies mitigate the threat of generic drugs and biosimilars? By launching the generic versions of their own branded drugs. For instance, recently, Mylan launched the generic version of its life-saving allergy injection EpiPen.

The latest company to launch generic versions of its branded drugs is Gilead Sciences. The Foster City, California-based Gilead said on Monday it is launching the authorized generic versions of its leading chronic hepatitis C virus (HCV) treatments in the United States — Epclusa (sofosbuvir 400mg/velpatasvir 100mg) and Harvoni (ledipasvir 90mg/sofosbuvir 400mg) — through a new subsidiary, Asegua Therapeutics LLC.

The authorized generics will launch at a list price of US$ 24,000 for the most common course of therapy and will be available in January 2019.

Gilead will benefit from this authorized generic in several ways. For instance, in the case of authorized generics, wholesalers typically get a lower percentage of the sales, and pharmacy benefit managers will not get the rebates that they were used to in the branded drug sales.

According to a statement issued by Gilead: “Since the launch of Gilead’s first HCV medication in 2013, the average price paid for each bottle of medicine in the United States has decreased by more than 60 percent off of the public list prices, across health insurers and government payers.”

Yet, Gilead added that these discounts may not always translate into lower costs for patients due to the complexity and structure of the US healthcare system.

Gilead said insurance companies will have the choice of offering either the authorized generics or the branded medications for both Epclusa and Harvoni.

The news comes a day after, a court in Brazil invalidated the exclusivity patent for the drug sofosbuvir, sold under the brand name Sovaldi.

As Brazil holds its presidential elections next month, center-left presidential candidate Marina Silva along with local pharmaceutical manufacturers Farmanguinhos-Fiocruz, Blanver and Microbiologica Quimica e Farmaceutica have been fighting for the right to produce a significantly cheaper, generic version of the Gilead drug.

Farmanguinhos has proposed to Brazilian health officials to produce a generic version of sofosbuvir for $8.50 per pill, about a quarter of the price charged by Gilead in Brazil.

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