On 26 August 2026, OncLive reported that Chia Tai Tianqing Pharmaceutical’s TQB2440 showed equivalent efficacy to its reference drug, Roche/Genentech’s Perjeta® (pertuzumab), in a Phase 3 clinical trial, when combined with trastuzumab and docetaxel as neoadjuvant therapy for patients with oestrogen receptor/progesterone receptor–negative, HER2-positive early or locally advanced breast cancer.
The study was first reported in ESMO Open in January 2026 and was conducted in 56 centres in China between 21 October 2020, and 14 August 2022. The study concluded that the safety, pharmacokinetic, and immunogenicity profiles of TQB2440 and reference pertuzumab were similar.
Henlius and Organon are leading the pertuzumab biosimilar race in major markets, with approvals of Poherdy® secured in the US (November 2025), EU (April 2026), and China (as Hanbeiyou®, May 2026). Approvals for pertuzumab biosimilars have been granted in India for Intas’ product (December 2024), Zydus’ Sigrima™ (June 2024, subject to ongoing litigation) and Enzene’s Pertuza®/Perzea® (launched September 2025). In Russia, Biocad’s Pertuvia™ (May 2025) and R-Pharm’s Persinthia™ (February 2026) are approved.
In June 2026, EirGenix announced that it signed an agreement with an undisclosed company for the licensing and commercialisation of its pertuzumab biosimilar, EG1206A, in Japan. This followed a 2025 global commercialisation deal with Sandoz for EG1206A, excluding Japan and a number of other countries in Asia.
Multiple pertuzumab biosimilars have been the subject of litigation by Roche and Genentech. Recently, BPCIA proceedings relating to 28 US patents were commenced against Biocon relating to its pertuzumab biosimilar, Bmab 1500. Roche and Genentech also filed BPCIA proceedings in August 2025 against Shanghai Henlius and Organon in relation to Poherdy®. Those proceedings were settled in January 2026 on confidential terms. In March 2026, Genentech commenced legal proceedings against Biocad before the Moscow Arbitration Court alleging patent infringement due to Biocad’s Pertuvia™. Court action by Roche against Zydus regarding its pertuzumab biosimilar, Sigrima®, has been running in India since the Indian approval of the product in June 2024.