NEW DELHI – India cleared two hepatitis C generics drugs within a week, setting the stage for fierce competition between the two Hyderabad-based companies and, possibly, lower prices for much needed drugs.

Hyderabad-based Hetero Drugs Ltd. announced on Dec. 9 that it had become the first company in India to receive approval for a fixed-dose combination of Ledipasvir-Sofosbuvir (90 mg/400 mg) from the Drug Controller General of India (DCGI) for treatment of chronic hepatitis C (HCV) patients. Hetero's Ledisof is a generic version of an original combination drug Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg; Gilead Sciences Inc.) that was FDA-approved in October 2014. Both Ledipasvir and Sofosbuvir inhibit replication of HCV. Hetero had signed a non-exclusive licensing agreement with Gilead in September 2014 to manufacture and market chronic HCV medicines.

Less than a week later, on Dec. 14, Hyderabad-based Natco Pharma Ltd. said it received DGCI approval for the generic version of Daclatasvir tablets (30 mg, 60 mg). The product in combination with Sofosbuvir is indicated for the treatment of the strain of HCV most prevalent in India out of six known strains, genotype 3. Natco's product is a generic version of Bristol-Myers Squibb Co.'s brand Daklinza (daclatasvir) which was FDA-approved in July 2015.

Daclatasvir is a direct-acting antiviral. Research studies show that the drug speeds up the decline of the HCV.

Hetero's chairman, BPS Reddy, said his company "looks forward in bringing a paradigm shift in HCV management in the country" with the launch of Ledisof.

HCV is a huge health concern in India, where there are an estimated 12 million to 18 million patients.

There are now several new medicines, taken as tablets once or twice a day, to treat HCV. Some are taken alongside pegylated interferon and/or ribavirin, while some others can be taken on their own or in combination with other new medicines. These medications are part of a class of drugs called direct-acting antivirals (DAAs), which interfere with the enzymes HCV needs to multiply. There are eight drugs currently in the market in India, including Genentech Inc.'s Pegasys (peginterferon alfa-2b), Merck Sharp & Dohme Corp.'s Pegintron (peginterferon alfa-2b) and Victrelis (boceprevir), Incivek (telaprevir) by Vertex Pharmaceuticals Inc., Johnson & Johnson's Olysio (simeprevir), Sovaldi/Harvoni from Gilead and Vekira Pak from Abbvie Inc.

The clearance for the two new drugs comes amidst issues of high pricing and access that have dogged HCV even in rich countries such as the U.S.

For example, Harvoni's predecessor drug from Gilead, Sovaldi, which was the first drug that did away with injection-based treatments and was cleared by the FDA in December 2013, is currently priced at $1,000 per pill or $84,000 for a three-month course out of reach for patients in India and other developing countries.

In a study from Liverpool University published in Clinical Infectious Diseases in 2014, Andrew Hill, senior visiting research fellow at the university's department of pharmacology and therapeutics, showed that sofosbuvir could be produced at as little as $68-$136 for a three-month treatment course.

India, ever a hub of patent battles between big pharma companies and smaller generics makers, has seen its share of face-offs between Gilead and Natco. In January 2015, an Indian patent office rejected Gilead's patent application for Sovaldi, which made it easier to make low-cost versions of the drug.

The patent office, however, granted regulatory approval for the drug, making India the first Asian country to do so.

Leena Menghaney, coordinator of the Access Campaign in India at Medicins Sans Frontieres (MSF), told BioWorld Today that Natco's Daclatasvir is more relevant to the country as it can treat all genotypes, especially genotype 3, unlike Harvoni that is more relevant to the HCV genotype more prevalent in the U.S.

Menghaney said she expects "fierce competition between Hetero and Natco in India" and prices could fall further in a year's time to half of the current $1,000 for a treatment course.

Clearance for the two Indian generics comes at a crucial juncture when the market for HCV drugs is poised to grow rapidly and there is a demand for lower-priced drugs.

A September 2015 market study by Renub Research suggests the market for HCV drugs grew at a phenomenal rate of more than $13 billion in 2014 compared to 2013. Gilead currently dominates the market but Abbvie has been trying to increase its market share with its Viekira Pak.