Brazil approves Henlius and Organon's pertuzumab biosimilar for HER2-positive breast cancer

Brazil's health regulator has approved Henlius and Organon's pertuzumab biosimilar for certain HER2-positive breast cancer patients, marking the country's first authorisation of a biosimilar to this established oncology antibody.

Henlius and Organon announced on 9 November 2026 that Brazil's National Health Surveillance Agency, Anvisa, had granted marketing authorisation for their pertuzumab biosimilar for specified HER2-positive breast cancer indications, supported by analytical, pharmacokinetic and comparative clinical evidence demonstrating biosimilarity to the reference medicine.

The Brazilian decision follows earlier US FDA approval in November 2025 and European Commission authorisation in April 2026, with Brazil and European commercial launches planned for 2027 under an existing Genentech settlement and licence agreement, making this a new country-specific approval rather than a new US or EU authorisation or immediate product launch.

Field	Content
Article Type	Approvals
Developer	Henlius
Commercial Partner	Organon
Product	Pertuzumab biosimilar
Active Ingredient	Pertuzumab
Regulatory Authority	Brazilian Health Regulatory Agency
Regulatory Authority Name	Anvisa
Country	Brazil
Announcement Date	9 November 2026
Approval Type	Marketing authorisation
Regulatory Status	Approved in Brazil for specified HER2-positive breast cancer indications
First-in-Market Status	First pertuzumab biosimilar approved in Brazil
Therapeutic Area	Oncology
Cancer Type	HER2-positive breast cancer
Biologic Class	Monoclonal antibody biosimilar
Molecular Target	HER2
Reference Product	Originator pertuzumab
Evidence Package	Analytical, pharmacokinetic and comparative clinical evidence
Biosimilarity Finding	Evidence supported biosimilarity to the reference biologic
Developer Responsibilities	Product development
Commercial Partner Responsibilities	Commercialisation under the existing licensing arrangement
Prior US Regulatory Approval	November 2025
Prior European Commission Authorisation	April 2026
Planned Brazil Launch	2027
Planned European Launch	2027
Relevant Commercial Agreement	Existing Genentech settlement and licence agreement
Immediate Commercial Launch	No; launch is planned for 2027
New US Approval	No
New EU Approval	No
What Happened	Anvisa granted Brazilian marketing authorisation for Henlius and Organon's pertuzumab biosimilar.
Why It Matters	The approval introduces a biosimilar regulatory option for HER2-positive breast cancer in Brazil, potentially supporting future competition and treatment access.
Regulatory Significance	Establishes the first Brazilian authorisation of a pertuzumab biosimilar.
Commercial Significance	Creates a regulatory foundation for a planned Brazilian launch in 2027.
Key Takeaway	Henlius and Organon secured a new Brazilian biosimilar approval for pertuzumab, distinct from previously granted US and EU authorisations.
What to Watch	Brazilian commercial launch, pricing, reimbursement, oncology adoption and implementation of existing licensing arrangements.
Primary Source	Henlius
Primary Source URL	https://www.henlius.com/en/newsd/0/31698.html?title=New-biosimilar-for-patients-with-certain-HER2-positive-breast-cancer-is-approved-by-Anvisa
Relevant Date	9 November 2026

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