On July 28, 2025 — World Hepatitis Day — Bangladesh-based Beacon Pharmaceuticals officially introduced Sofosvel, the world’s first generic version of Epclusa (SOF/VEL). This milestone has not only drawn attention domestically but also sent a strong signal to the global hepatitis C (HCV) treatment landscape.
Traditionally, treatment strategies for HCV depended on genotype testing since there are six main HCV genotypes (with genotype 1, 2, and 3 being most common). The arrival of Sofosvel marks a turning point: as a pan-genotypic direct-acting antiviral (DAA), it is capable of treating all six HCV genotypes. Moreover, in patients with moderate-to-severe cirrhosis, it can be combined with ribavirin, thereby broadening clinical applicability and simplifying treatment.
In Phase III clinical trials, the original Epclusa demonstrated remarkable outcomes:
SVR12 (sustained virologic response at week 12) reached approximately 98% in patients without cirrhosis or with compensated cirrhosis.
In decompensated cirrhosis, Epclusa + ribavirin achieved an SVR12 of 94%.
No major safety concerns were observed.
As a generic, Sofosvel shares the same active ingredients, formulation, dosage, and mechanism of action as Epclusa. Therefore, experts widely agree that its efficacy is beyond question.
Beacon, one of Bangladesh’s leading pharmaceutical companies, has built WHO- and EU-standard facilities and currently manufactures around 200 generics and 65 oncology medicines. With its strong production capacity and market reach, Sofosvel is expected to accelerate the adoption of affordable DAAs across South Asia, Southeast Asia, and other resource-limited settings.
Global Trends Intersecting with Sofosvel’s Launch:
- Generics and authorized generics are becoming strategic tools for big pharma. For instance, Gilead has announced authorized generics of Epclusa and Harvoni in the U.S. to reduce treatment costs.pharmacytimes.com+1
- Real-world evidence continues to validate the strong efficacy and safety of SOF/VEL across diverse patient populations.Frontiers
- Despite >95% cure rates, treatment coverage remains low. WHO reports highlight that millions remain undiagnosed or untreated.World Health Organization
- Patent and regulatory barriers persist. While sofosbuvir patents have expired, velpatasvir patents may remain active for years, potentially delaying widespread generic entry.synapse.patsnap.com
- Alternative combinations for LMICs (low- and middle-income countries), such as ravidasvir + sofosbuvir, are being developed to lower costs and expand access.dndi.org
Well-known pharmaceutical company in Bangladesh：https://www.radiantpharmacil.com
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