On 8 September 2026, Biocon announced that, in partnership with Brazilian state-owned pharmaceutical laboratory, Bahiafarma, and Brazilian biotechnology company, Bionovis, it has entered a 10-year contract to supply Bmab 1500, biosimilar to Roche/Genentech’s Perjeta® (pertuzumab), under Brazil’s Productive Development Partnership (PDP) program.
Under the PDP, the partnership will have exclusive access to Brazil’s public healthcare market, which accounts for approximately 70% of the country’s total market. Biocon will receive milestone payments and a share of revenues generated from the PDP opportunity over a 10-year period.
The deal had been foreshadowed at the India-Brazil Business Forum in February 2026, along with a similar partnership between Dr Reddy’s, Bionovis and Bahiafarma to manufacture biosimilar nivolumab in Brazil.
Biocon is currently being sued by Roche/Genentech in the US in relation to Bmab 1500, with BPCIA proceedings commenced in July 2026. The litigation arises from Biocon’s submission of an abbreviated Biologics License Application (aBLA) for Bmab 1500, the date of filing of which is confidential. Roche/Genentech allege Biocon infringes 28 US patents for inventions related to Perjeta® and various manufacturing methods for antibody production, covering pertuzumab as well as its use and manufacture.
Genentech also filed an ITC complaint in February 2026 against Biocon’s importation of Bmab 1500 into the US, alleging that, on 18 October 2025, Biocon imported more than 17,800 units of BMAB 1500 into the US from India before it received FDA approval
Shanghai 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). BPCIA litigation filed by Roche/Genentech against Henlius/Organon was settled in January 2026 on confidential terms.
Approvals for pertuzumab biosimilars have been granted in India for Intas’ product (December 2024), Zydus’ Sigrima™ (June 2024) and Enzene’s Pertuza®/Perzea® (launched September 2025). In Russia, Biocad’s Pertuvia™ (May 2025) and R-Pharm’s Persinthia™ (February 2026) are approved. Litigation has been brought by Roche/Genentech against Biocad in Russia and Zydus in India.
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.