В Бангладеш появился дженерик HCV-препарата "Sovaldi" за $900

A $10 version of Sovaldi, the Gilead Sciences Inc. hepatitis C treatment that sells for $1,000 a pill in the U.S., is now available in Bangladesh and could make its way to other parts of the world where the U.S. company doesn’t have patents.

Incepta Pharmaceuticals Ltd. doesn’t have a license from Gilead and its version was launched last month, said Managing Director Abdul Muktadir. The company also aims to sell the drug overseas, including to parts of Southeast Asia and Africa.

The generic drugmaker has beaten to the market a number of larger Indian competitors that were licensed by Gilead to produce low-cost versions of Sovaldi for 91 countries that are mostly poor. Nations not covered by Gilead’s license, including Thailand, Malaysia and Morocco, and countries where Sovaldi isn’t patented could benefit from the new source of cheap copies.

Incepta’s price of about $900 for 12 weeks is the same price at which Gilead will offer its branded version of the drug in India. Even so, the Bangladeshi version shows the challenge facing Gilead from companies it doesn’t have agreements with in countries where the drug isn’t patented.

The World Health Organization said it is in talks with Incepta for its prequalification programme, which assesses drug quality. International aid agencies and countries look to this WHO certification as a reference when picking drugs for bulk purchases.

Gilead is “aware of unauthorized generic versions of sofosbuvir being offered in the marketplace,” the company said in an e-mail. “We’re focused on enabling our eleven Indian generic partners to launch their authorized generic versions as soon as possible.”

Marketplace

Under a World Trade Organization agreement, Bangladesh, as one of the world’s least developed countries, doesn’t have to protect pharmaceutical patents.

In the U.S., Sovaldi has sparked a backlash from commercial health insurers because of its cost of $84,000 for a 12-week course of treatment. In the rest of the world, the price of the drug is already set to plunge as Gilead’s licensees start selling.

Hyderabad-based Natco Pharma Ltd., one of Gilead’s licensees, launched its generic sofosbuvir in Nepal this month. Natco in a statement Monday said it had priced its generic medicine at 19,900 rupees ($318) for a bottle of 28 tablets in Nepal.

A number of other Sovaldi generics besides Incepta’s, also not authorized by Gilead, are in the works in Egypt, according to the Egyptian Initiative for Personal Rights.

The WHO is in talks with Incepta along with a “handful” of companies in India and Egypt on pre-qualification of Sovaldi generics, said Peter Beyer, senior advisor in WHO’s department of essential medicines and health products in Geneva.

Dhaka-based Incepta is currently preparing quality and dissolution studies on its version of sofosbuvir to submit in support of its international applications, Muktadir said.

“We are just a little ahead of them,” said Muktadir of his Indian competitors. “So, maybe we should be able to launch these products wherever it is required. In some countries in Africa, and some of the Southeast Asian countries where the burden is very high -- these are the countries we are looking at.”

Incepta’s sofosbuvir is approved for sale by the Bangladeshi drug regulator, said Mohammad Salahuddin, assistant director at the Directorate General of Drug Administration.