DCGI approved sale of Sofosbuvir-Ledipasvir combination
Biocon has announced the introduction of an advanced novel therapy CIMIVIR-L for the treatment of Hepatitis C in India. CIMIVIR-L is a fixed dose combination of Ledipasvir 90 mg and Sofosbuvir 400 mg, which is an equivalent of the innovator product commercialized by Gilead Sciences in the US.
The Drugs Controller General of India (DCGI) recently approved the sale of Sofosbuvir-Ledipasvir combination, which is being manufactured in India under a license from Gilead.
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). It is estimated that nearly one lakh people die annually in India from HCV infection and co-morbidities. It is indicated for Hepatitis-C Genotype 1 patients who account for ~25 percent of the total estimated HCV patient population of 18 million in the country.
CIMIVIR-L will be made available to patients in India at a fraction of the global cost of the innovator brand. The cost of a 12-week course of this combination therapy in the US is $94,500, (~ Rs 63 lakhs).
In keeping with its commitment to introduce innovative therapies at an affordable price to patients, Biocon had entered into a licensing agreement last year with US-based Gilead to manufacture and commercialize its chronic Hepatitis-C blockbuster product range, Sofosbuvir and Sofosbuvir-Ledipasvir combination in India and in select emerging markets.