With drug substance GMP approval from ANVISA and international regulatory progress, access to cancer immunotherapy in Brazil may be fundamentally transformed

SÃO PAULO, Jan. 23, 2026 /PRNewswire/ -- Blau Farmacêutica, a Brazilian pharmaceutical company listed on Brazilian Stock Market (B3) and a regional leader in hospital pharmaceuticals with a strong presence across Latin America, announces an important achievement for science, healthcare, and the bio-pharmaceutical industry in Brazil: the fully integrated development in Brazil of a pembrolizumab biosimilar, one of the most widely used and advanced immunotherapies for the treatment of multiple types of cancer.

For the first time, a Brazilian company has achieved full end-to-end development of a high-complexity monoclonal antibody (anti-PD-1), covering drug substance and drug product. All stages — including cell line development, bioprocess development, biological characterization, comparability studies, preclinical and clinical development, global regulatory strategy, and large-scale manufacturing — are conducted in Brazil in compliance with international standards.

The project was conducted by Blau in partnership with the Inventta Institute of Science, Technology and Innovation (ICT) and engaged more than 200 qualified professionals—PhDs, MScs, engineers, clinical researchers, and regulatory specialists—constituting a large, coordinated scientific development effort within Brazil's biopharmaceutical sector.

Regulatory Validation and Global Standards

Brazil's health authority, ANVISA, has audited and approved the industrial manufacturing process of Blau's pembrolizumab biosimilar, granting Good Manufacturing Practices (GMP) certification for the production of the active pharmaceutical ingredient (API).

"This approval confirms that Brazil now possesses the industrial and technological capability to manufacture, at global quality standards, one of the most complex and widely used immunotherapies in modern oncology," said Uilberson Silva, CEO of Inventta – ICT.

The development program has received scientific advice from the European Medicines Agency (EMA) and is awaiting feedback from the U.S. Food and Drug Administration (FDA) in the coming months. The program was designed in full alignment with EMA, FDA, ANVISA, ICH and PIC/S guidelines, enabling future global commercialization.

A Shift in the Global Biosimilars Landscape

This milestone places Brazil among a select group of countries capable  producing complex monoclonal antibodies at industrial scale, signaling a meaningful shift in the global biosimilars landscape — traditionally dominated by companies from USA, Europe and Asia.

Brazilian bio-pharmaceutical companies are now emerging as credible global developers and manufacturers of high-complexity biologics, combining:

• ⁠Scientific and technical talent comparable to U.S. and European standards
• ⁠State-of-the-art manufacturing facilities equipped with the latest technologies
• ⁠A regulatory environment increasingly harmonized with FDA and EMA frameworks
• ⁠Cultural and operational alignment with Western regulatory and quality standards, combined with agile and efficient regulatory interactions.\

ANVISA has played a decisive role in this transformation by continuously updating its regulatory framework and maintaining close alignment with international agencies, fostering modernization and global competitiveness among Brazilian manufacturers.

Market Opportunity

Pembrolizumab represents an estimated total addressable market (TAM) of approximately BRL 5 billion in Brazil, according to IQVIA. Blau is also developing three additional monoclonal antibodies, bringing the total domestic opportunity to BRL 8 billion.

Globally, the four biosimilar monoclonal antibodies under development represent a combined market opportunity of approximately USD 47 billion, positioning Blau to pursue strategic international partnerships and out-licensing opportunities in markets where patents have expired or are nearing expiration.

Patent expiry for pembrolizumab is expected in 2028 in Brazil, 2029 in the United States, and 2031 in Europe.

Clinical Development

Following ethics approval expected in Q1 2026, Blau will initiate a Phase I clinical study, designed to assess pharmacokinetics, safety, immunogenicity, and clinical efficacy.

During the Scientific advice EMA has indicated that, contingent on robust quality and Phase I data, a waiver of Phase III clinical trials may be possible, significantly accelerating patient access — a regulatory pathway consistent with leading global biosimilar programs.

Expanding Access to Cancer Immunotherapy

Pembrolizumab has transformed cancer treatment worldwide by significantly improving survival across multiple tumor types. However, in Brazil, access remains limited due to high costs and restricted public reimbursement.

With local production and substantially reduced costs, Blau's pembrolizumab biosimilar could reshape public health policy, enabling broader incorporation into Brazil's public healthcare system (SUS) following patent expiration.

Estimates suggest that more than 50,000 patients per year could gain access to immunotherapy in Brazil as a result of this initiative — a historic leap compared to current access levels.

"This is more than a pharmaceutical product," said Marcelo Hahn, CEO of Blau Farmacêutica. "It represents scientific sovereignty, industrial autonomy, and the opportunity to save many lives. Brazil now has the technical, regulatory, and industrial foundation to stand among the world's leading bio-pharmaceutical innovators."

A Scientific, Industrial and Social Milestone

With GMP certification secured, international regulatory validation underway, and clinical development advancing, Brazil stands at a turning point in oncology: a globally competitive immunotherapy, developed and manufactured in Brazil, for patients in Brazil and around the world.

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SOURCE Blau Farmacêutica