Who: Biocon Limited
Where: Indian market
What: Launched generic version of hepatitis-C drug Harvoni
When: 24 December 2015
Biocon Limited on 24 December 2015 launched the generic version ofhepatitis – C drug in the Indian market. The generic version of the drug named Harvoni will be sold under the brand name CIMIVIR-L.
The generic drug Harvoni is an improved version of Gilead’s hepatitis-C drug Sovaldi or sofosbuvir and will come in fixed-dose combination ofledipasvir-sofosbuvir of 90mg and 400mg, respectively.
The sale of ledipasvir-sofosbuvir combination was recently approved by the Drugs Controller General of India (DCGI), which is being manufactured in India under a license from Gilead.
Harvoni has been approved by the US Food and Drug Administration (USFDA) for the treatment of chronic hepatitis-C genotype-1 infection and it has shown high cure rates of around 90 percent.
Earlier in the year 2015, Biocon entered into a non-exclusive licensing agreement with Gilead Sciences to manufacture and market chronic hepatitis-C medicines, including Sovaldi and Harvoni, for India and 91 other developing countries by paying 7 percent royalty on sales.
According to Biocon, the CIMIVIR-L, a once-a-day oral therapy, will offer a convenient, effective and safe alternative to people infected with the Hepatitis-C virus (HCV).
• Hepatitis-C is a viral disease that causes liver inflammation leading to diminished liver function or liver failure.
• It is referred to as a silent epidemic as most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades.
• Chronic HCV infection could lead to scarring and poor liver function (cirrhosis) over many years, resulting in complications such as bleeding, jaundice, fluid accumulation in the abdomen, infections and liver cancer.
• It is estimated that nearly 100,000 people die annually in India from HCV infection and co-morbidities. Around 25% of 18 million HCV patients in India are indicated for hepatitis-C genotype 1.