Given the high price of Gilead Sciences' ($GILD) hepatitis C cure Harvoni, it wasn't going to be long before it was targeted by counterfeiters. Now fakes have shown up in Switzerland and Israel.
The Swiss Agency for Therapeutic Products (Swissmedic) reports that counterfeits of the drug were discovered in Israel. They were shipped there through a Swiss trading company, which got them from India. In India, the drug runs about $10 a pill, compared to the sticker price of about $1,100 per pill in the U.S.
The regulators explained the plastic bottles contained pills which were white coated, instead of the "genuine yellow film-coated tablets." Swissmedic is now working with other European authorities to determine whether counterfeit Harvoni packs were shipped to other countries.
The regulator said it was known that because of the high price and limited access of Harvoni in Switzerland that some patients have been "buying it abroad." But it warned consumers against buying from online pharmacies where there is no guarantee that drugs are genuine. There are websites that tell consumers how to order the drug directly from India.
When Sovaldi first came to the market, Gilead provided the manufacturing technology to Mylan ($MYL) and 6 Indian generics makers so that they could manufacture cheaper versions for sale in 91 developing markets. In late 2014, the Indian government warned companies in Egypt to stop advertising they had for sale Indian-made versions of Sovaldi. At the time none of the 7 drugmakers that were granted the right to produce the drug had gotten past development with the product.
According to Regulatory Focus, counterfeits of Gilead's first hep C pill Sovaldi have been found in Pakistan.
- read the Swissmedic report
- more from Regulatory Focus
Special Report: The top 20 drugs in 2020--worldwide sales - 4. Harvoni