On 22 September 2025, Enzene Biosciences announced the Indian launch of its biosimilar to Roche’s Perjeta® (pertuzumab). According to Enzene, the biosimilar is being marketed in India by “multiple leading pharmaceutical companies”. This includes Enzene’s parent company, Alkem Laboratories, which is marketing the biosimilar under the name Pertuza®, and Hetero Healthcare, which has announced the launch of the Enzene biosimilar under the name Perzea®.
Other pertuzumab biosimilars approved in India include Intas’ biosimilar (approved December 2024) and Zydus’ Sigrima™ (approved June 2024). Sigrima™ is the subject of legal action in India by Roche, which is alleging infringement of patents IN268632 and IN464646.
Roche has recently indicated that biosimilar competition to Perjeta® is a bigger concern than it previously anticipated. As well as the Indian proceedings against Zydus, Roche has also sued Shanghai Henlius and Organon in the US, alleging that their pertuzumab biosimilar, HLX11, infringes multiple US patents.