On 28 May 2025, Russia’s GxP News reported that the Russian Ministry of Health approved Russian biotechnology company Biocad’s Pertuvia™, biosimilar to Roche’s Perjeta® (pertuzumab), making it the country’s first domestic biosimilar pertuzumab approved for HER2-positive breast cancer.
This approval comes a month after Roche stated that it did not expect its Perjeta® to face biosimilar competition from Henlius’ HLX11 (pertuzumab) until late 2027. HLX11 is currently under consideration by regulators in the EU, US and China.