The Swiss regulator announced the detection of counterfeit Harvoni (sofosbuvir/ledipasvir) on Friday, explaining that the fake products originated in India and made their way to Israel via a Swiss trading company.
Swissmedic told us “We got this information from the Swiss trading company who shipped the drugs to Israel.”
The organisation added that: “Unfortunately we are not allowed to name the company yet” citing articles 61 to 64 of the Swiss Federal Act on Medicinal Products and Medical Devices.
Israeli authorities did not respond to a request for comment, however, according to press reports three packages of fake Harvoni have been seized.
The fake pills are white rather than the yellow like the genuine product according to Swissmedic which said it is working with European authorities to see if the counterfeits have reached other markets.
Price and availability
Swissmedic cited the case as a warning against buying pharmaceutical products from unapproved sources.
The regulator said the limited availability of Harvoni as well as the high cost of the product - in the US a 12-week course costs $94,500 - is prompting some Swiss hepatitis patients to buy them online or from other international sources.
“There is no guarantee that medicines sold at very low prices from countries with no comparable medicines control system actually contain the declared active ingredient or the correct dosage of that active ingredient.”
Harvoni was authorised in Switzerland in 2014.