Agency to start testing, approving generic versions of insulin

insulin prices skyrocketing and substantial shortages developing in poorer countries, the World Health Organization says it will begin testing and approving generic versions of the drug.

Agency officials say they hope to drive down insulin prices by encouraging makers of generic drugs to enter the market, increasing competition. At the moment, the world’s insulin market is dominated by three companies

— Eli Lilly, Novo Nordisk and Sanofi — and they’ve steadily pushed up prices for two decades.

“Four hundred million people are living with diabetes, the amount of insulin available is too low and the price is too high, so we really need to do something,” Emer Cooke, the WHO’s head of regulation of medicines and health technologies, said as she announced the plan Wednesday.

The approval process, which the WHO calls “prequalification,” will permit U.N. agencies and medical charities to buy approved generic versions of insulin.

The process also could reassure countries without strong regulatory agencies that the approved drugs are safe for their health ministries to purchase.

Though insulin has been on the WHO’s essential medicines list for over 40 years, about half the 80 million people who need regular injections of insulin can’t get what they need because they or their country’s health systems can’t afford it, the WHO said.

In the U.S., where the price of a vial has risen to $275 from $35 over two decades, diabetics without good health insurance are forced to ration whatever they can afford or to buy insulin on the black market.

Drug companies making insulin for domestic use exist in India, China, Poland, Ukraine, the United Arab Emirates, Brazil, Mexico and Russia, Cooke said.

Several already have exWith pressed interest in entering the global market if they can win WHO approval.

UNICEF, the United Nations Development Program and Doctors Without Borders have said they would be likely to buy insulin from WHO-certified suppliers, Cooke said.

“We’ve been waiting for this for a long time,” said Christa Cepuch, the pharmacist coordinator of the access to medicines campaign at Doctors Without Borders.