Counterfeit Harvoni from India found in Israel
- The Swiss regulatory agency, Swissmedic, has discovered counterfeit versions of the blockbuster hepatitis C drug Harvoni in Israel. The fake drugs originated from India and were imported through a Swiss trading company, Swissmedic said in a safety alert.
- Plastic bottles were found to contain Harvoni tablets with a white film coating, rather than the actual yellow film coating.
- Harvoni’s high list price, nearly $95,000 for 12 weeks of treatment in the US, has prompted patients and cost regulators to seek alternatives. The drug is often sold at cheaper prices outside of the U.S. and Europe.
Swissmedic warned that the counterfeit versions of Harvoni are not guaranteed to be safe or effective, and that they may or may not actually contain the declared API or the correct dosage.
In its alert, the regulator noted high prices have apparently motivated Swiss patients to purchase Harvoni abroad. Since the drug is orally administered, it is easier to self-administer.
Authorized generics of other Gilead hep c meds do exist, even as some seek to circumvent the regulatory process with counterfeit versions. In 2014, Gilead licensed 11 generic Indian drugmakers to make and sell generic versions of Gilead’s older Sovaldi. Mylan has also launched a generic version and will soon be launching a branded version in India—at a cost to patients of $300 per month.
Swissmedic is continuing to investigate whether the counterfeit Harvoni was imported into other countries.
- Regulatory Affairs Professional Society Counterfeit Versions of Gilead’s Blockbuster Hepatitis C Drug Found in Israel