The (National Health Surveillance Agency) published this Tuesday (June 2, 2026) a measure that determines the seizure of batches of counterfeit medicines used in cancer treatments. The decision affects counterfeits of Keytruda, indicated for various types of cancer, and Kadcyla, used to treat HER2-positive breast cancer. Here is the resolution (PDF – 115 kB).
In the case of Keytruda, the suspicion of counterfeiting was reported by Merck Sharp & Dohme Farmacêutica, holder of the medicine’s registration. According to the company, the serial number, referring to batch Y019149, manufactured on July 31, 2024, is not recognized as genuine. Anvisa’s resolution determines the seizure of the batch of product, manufactured by an unidentified company.
The agency also ordered the seizure of lots H6980H05 and H8249A43 from Kadcyla. According to Roche, responsible for registering the medicine, units with characteristics that differ from the original product were identified on the market.
Among the problems observed are:
- graphic art flaws;
- discrepancies in tamper-evident seals on the packaging;
- absence of 2D DataMatrix code
- serial number not recognized by the company;
- differences in the label, cap, stopper and physical shape of the bottle;
- flaws in the leaflet and incoherent texts in a foreign language.
Chemical analysis also confirmed the absence of the active ingredient trastuzumab emtansine in the Kadcyla vials. According to the resolution, only sorbitol was identified in the contents of the bottle, which characterized the product as falsification.
With the preventive measure, the sale, distribution and use of affected lots are prohibited. The resolution has been in effect for 6 days.
