Switzerland's medicines regulator is concerned that European consumers may be at risk of encountering counterfeit versions of Gilead Sciences' hepatitis C drug Harvoni.
Swissmedic reports that Harvoni (sofosbuvir/ledipasvir) packs with counterfeit contents have been discovered in Israel and seem to originate from a company in India.
Harvoni has become a massively successful brand with sales of nearly $14bn last year, because it the orally-active drug represents a huge advance over earlier-generation injectable regimens based on interferon alfa. That success has made it a target for counterfeiters, a situation made more perilous by the high price of the drug that has made access difficult in some markets.
Gilead has agreed deals with low-cost generic producers of the drug in low-income countries, which have cut the cost of the drug from $1,000 a pill in the US to around $1. For many poor people even this reduction is not enough to allow access, while patients in middle- and high-income countries can also struggle to get reimbursement.
"Treatments that use the latest generation of hepatitis C medicines are limited in Switzerland and very expensive compared with other countries, says Swissmedic. "Consequently, according to media reports, Swiss patients are purchasing Harvoni and other preparations abroad."
The agency says plastic bottles purporting to contain Harvoni were imported via a Swiss trading company and on inspection were found to contain white instead of genuine yellow film-coated tablets.
Swissmedic said it is "working with other European authorities to establish whether Harvoni packs with counterfeit contents have also been imported into other countries." It advises against purchasing any medicine from unknown sources, and particularly against ordering drugs over the Internet.