On 14 October 2026, Biocon announced that it has entered a global settlement and licence agreement with Genentech for Pebrilzo® (Bmab 1500), biosimilar to Genentech’s Perjeta® (pertuzumab). The settlement permits Biocon to launch Pebrilzo® in the EU/UK in Q1/2027, in the US in Q3/2028 and in 2026-2028 in other Rest of World countries (or earlier in certain circumstances).
According to Biocon, the agreed launch dates for Pebrilzo® are the earliest licensed launch dates for a pertuzumab biosimilar. Shanghai Henlius/Organon settled BPCIA proceedings brought by Roche/Genentech in relation to the pertuzumab biosimilar, Poherdy® in January 2026, but they have not announced their licensed launch dates.
The Biocon settlement resolves BPCIA proceedings commenced against Biocon by Roche/Genentech in July 2026 in relation to biosimilar pertuzumab. Roche and Genentech were alleging that Biocon infringes 28 US patents for inventions related to pertuzumab and various manufacturing methods for antibody production, covering pertuzumab as well as its use and manufacture. The settlement also resolves an ITC complaint filed by Genentech in February 2026 against Biocon’s importation of Bmab 1500 into the US.
Biocon has submitted an abbreviated Biologics License Application (aBLA) to the FDA for approval of Pebrilzo®, the date of filing of which is confidential. The EMA’s CHMP adopted a positive opinion for Pebrilzo® in September 2026 for the treatment of HER-2 positive breast cancer (420 mg concentrate for solution for infusion).
Shanghai Henlius and Organon had been leading the pertuzumab biosimilar race in major markets, with Poherdy® approvals secured in the US (November 2025), EU (April 2026), and China (as Hanbeiyou®, May 2026).
Approvals for pertuzumab biosimilars have also 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, subject to litigation) 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.