On 4 September 2025, Brazil’s National Health Surveillance Agency (Anvisa) announced that it seized a batch of a drug sold under the name Opdivo®, after medicine registration owner Bristrol-Myers Squibb notified Anvisa that the batch was not known to be genuine.
Counterfeit Opdivo® has previously been reported in the USA, resulting in a United States federal grand jury indicting a person from India for allegedly selling the counterfeit cancer drugs and shipping them to Houston.
As previously reported in the context of counterfeit supply of Novo Nordisk’s semaglutide products Ozempic® and Wegovy® in the US, counterfeit drugs are often combated by civil lawsuits. When a counterfeit product contains no active ingredient, patent protection is unlikely to apply and any civil suit would need to rely instead on trade mark rights, fair trading laws and other related law applicable in the relevant jurisdiction. It is not known whether any manufacturer will file a civil suit in relation to this case.
At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development, and Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024.