New Biosimilar For Patients With Certain HER2-Positive Breast Cancer Is Approved By Anvisa

Developed by Henlius and licensed to Organon, the drug is the first pertuzumab biosimilar approved by Regulatory Agency in Brazil

A new pertuzumab biosimilar is now part of the treatment approved in Brazil for patients with certain HER2-positive breast cancer. Developed by Shanghai Henlius Biotech and with commercialization rights licensed to Organon, the drug is the first pertuzumab biosimilar approved in the country, after registration granted by the National Health Surveillance Agency (Anvisa)¹.

"Biologic treatments have expanded the oncology treatment landscape, including in the fight against breast cancer, one of the diseases that most impact women worldwide," says Ricardo Lourenço, Managing Director of Organon Brazil. "The approval of the pertuzumab biosimilar reflects our commitment to improving women's health, contributing to expanding access to biologic therapies for conditions that disproportionately affect women. Through our collaboration with Henlius, we work to support a future in which more patients can benefit from these important treatments, while contributing to a more sustainable health system."

The pertuzumab biosimilar is administered by intravenous infusion and is indicated, in combination with trastuzumab and docetaxel, for the treatment of adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. In combination with trastuzumab and chemotherapy, it is also indicated for the neoadjuvant treatment (before surgery) of adult patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer at high risk of recurrence (tumors greater than 2 cm in diameter or node-positive disease), as part of a complete treatment regimen for early breast cancer. It is also indicated, in combination with trastuzumab and chemotherapy, for the adjuvant treatment (after surgery) of adult patients with HER2-positive early breast cancer at high risk of recurrence².

The new biosimilar was approved based on a broad set of data, which included analyses of its structure and function studies on how the drug is absorbed, comparing drug levels in the blood over time and processed by the body, and comparative clinical studies. The body of evidence demonstrated that the pertuzumab biosimilar is highly similar to the reference biologic drug in aspects such as efficacy, safety, and immunogenicity, that is, the ability to elicit an immune system response³.

The approval in Brazil adds to the authorizations obtained for the drug in the United States and the European Union, expanding the potential global reach of this biosimilar. A pertuzumab biosimilar was approved by the US regulatory agency Food and Drug Administration in November 2025 and received authorization from the European Commission in April 2026. The Companies entered into a settlement and license agreement with Genentech, Inc. and related parties (“Genentech”) with planned launches in Brazil and the EU in 2027. Regulatory submissions are planned in additional markets through 2028.

HER2-positive breast cancer represents about 15% to 20% of all breast cancers⁴. According to the National Cancer Institute (INCA), more than 78 thousand new cases of breast cancer among women are estimated per year in the country between 2026 and 2028. The predicted risk is approximately 71 cases per 100 thousand women. With the exception of non-melanoma skin tumors, breast cancer is the most common type of cancer among Brazilian women⁵.

In 2022, Henlius entered into a licensing and supply agreement with Organon, granting the company the exclusive rights to commercialize several biosimilars, including the pertuzumab biosimilar. The agreement contemplates exclusive commercialization rights worldwide, except in China⁶.

References:

^1. National Health Surveillance Agency (ANVISA). Resolution-RE No. 4,078, of October 16, 2026. Grants the registration of the biological product POHERDY (pertuzumab), a path of development by comparability. Federal Official Gazette. 19 Oct 2026.

^2. POHERDY product leaflet. Organon Farmacêutica Ltda. 19 Oct 2026.

^3. Brazil. National Health Surveillance Agency (ANVISA). Resolution RDC No. 875, of May 28, 2024. Provides for the registration of biosimilars through the comparability development pathway. Federal Official Gazette. May 29, 2024. Brasília (DF).

^4. BRAZIL. Ministry of Health. Secretariat of Science, Technology, Innovation and Strategic Inputs in Health. Department of Management and Incorporation of Health Technologies and Innovations. Trastuzumab emtansine in the adjuvant treatment of HER2-positive breast cancer operated at stage III with residual disease in the surgical specimen after neoadjuvant treatment: report to society: nº 348. Brasília: Ministry of Health, jul. 2022. Available at: https://www.gov.br/conitec/pt-br/midias/consultas/relatorios/2022/sociedade/20220912_resoc_348_trastuzumabe_estadio_iii_final.pdf/@@display-file/file. Accessed on: 19 out. 2026.

^5. NATIONAL CANCER INSTITUTE. INCA estimates 781 thousand new cases of cancer per year in Brazil between 2026 and 2028. Rio de Janeiro: INCA, 4 Feb. 2026. Available at: https://www.gov.br/inca/pt-br/assuntos/noticias/2026/inca-estima-781-mil-novos-casos-de-cancer-por-ano-no-brasil-entre-2026-e-2028. Accessed on: 19 Oct. 2026.

^6. Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta (Pertuzumab) and Prolia/Xgeva (Denosumab) Biosimilar Candidates. Organon. June 13, 2022. Accessed April 14, 2026. https://www.organon.com/news/organon-enters-into-global-license-agreement-to-commercialize-henlius-investigational-perjeta-pertuzumab-and-prolia-xgeva-denosumab-biosimilar-candidates/