First Abbreviated New Drug Application filed for sofosbuvir (Sovaldi).
The cost of hepatitis C virus (HCV) antivirals has been at the forefront of health care spending conversations for years. Although it has slowed, spending on the blockbuster drugs remains high. Despite the curative ability of the treatments, it is likely that a significant need for antiviral drugs will remain into the foreseeable future due the prevalence of undiagnosed HCV cases.
A recent Vizient Drug Price Forecast outlined the top drivers of specialty pharmacy spending, one of which being HCV. The cost of HCV drugs is projected to increase 2.02% in 2018, which is slower than the past few years due to increasing competition and lower-cost options.
Natco Pharma recently announced it filed an Abbreviated New Drug Application (ANDA) for sofosbuvir tablets, 400-mg, according to a press release.
Sofosbuvir is currently marketed by Gilead Sciences under the brand name Sovaldi. Sofosbuvir was the first blockbuster HCV drug to receive approval in December 2013, shortly followed by Gilead’s ledipasvir/sofosbuvir (Harvoni) in October 2014.
Natco said it is the first to have filed a complete ANDA and expects to receive 180 days of exclusivity after final approval.
Between December 2016 and December 2017, Gilead said Sovaldi garnered $130 million in sales, which would drop significantly if a generic version received approval.
In August 2017, the FDA approved glecaprevir/pibrentasvir (Mavyret) to treat adults with HCV genotypes 1 through 6. The approval sent shockwaves through the market due to the significantly lower cost of $26,400 for a full course of treatment. Comparatively, Sovaldi was launched at a list price of $84,000.
If approved, the sofosbuvir generic has the potential to threaten big-name manufacturers that have invested heavily into HCV antivirals even more so than the approval of a lower cost brand.