Pembrolizumab - Biosimilar

Pembrolizumab - Biosimilar
Product Description

Our product is at an advanced stage of development and is entering the clinical phase, with global clinical studies planned across multiple countries in Latin America, Europe, and other international markets.

Our strategy for the development, aligned with FDA and EMA through Scientific Advice is to waive the Phase III, supporting a streamlined development pathway and accelerating the overall development timeline. Completion of the development program is expected by Q1 2028.

We are actively seeking licensing, commercialization, and strategic partners for the following territories:

United StatesEurope
Asia-Pacific
Middle East & North Africa (MENA)
Africa

Partnership opportunities include exclusive and non-exclusive commercialization rights, market access collaboration, and long-term strategic alliances.

Blau Farmaceutical S.A

  • Country/Region:
    Brazil
  • On CPHI since:
    2015
  • Certificates:
    3
  • Employees:
    1000 - 4999
Company types
Biopharmaceutical company
Primary activities
Biopharmaceutical

Blau Farmaceutical S.A

  • Country/Region:
    Brazil
  • On CPHI since:
    2015
  • Certificates:
    3
  • Employees:
    1000 - 4999
Company types
Biopharmaceutical company
Primary activities
Biopharmaceutical

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Blau Farmaceutical S.A resources (3)

  • News Blau Farmacêutica Fully Develops One of the World's Most Advanced Biosimilars Immunotherapies

    Com a certificação de Boas Práticas de Fabricação (BPF) concedida pela ANVISA e o avanço das regulamentações internacionais, o acesso à imunoterapia contra o câncer no Brasil poderá ser transformado.

  • Report Sustainability Report 2025

    Check out our 2025 Sustainability Report. This document reflects our commitment to sustainable and responsible practices across all our operations, helping preserve the present while contributing to a more equitable and balanced future.

    The report provides an overview of our key achievements over the past year:
    Advances in Research, Development, and Innovation;Investments in Social Projects, reinforcing our commitment to the communities where we operate;Progress in implementing best practices across our industrial processes, contributing to waste reduction.Sustainability is an integral part of our business strategy and embedded in our culture. We believe that building a better future starts with responsible decisions made today, integrating social, environmental, and governance principles into everything we do.

  • Datasheet Blaū Pharmaceutical - Innovation​ in health for the World

    Blaū Pharmaceutical is a regional company with a strong presence across Latin America, a leader in the hospital pharmaceutical segment* and a pioneer in biotechnology in Brazil.​

    We are a publicly traded company listed on the Brazilian Stock Exchange (B3) under the ticker “Blau3.” Our commitment is to deliver innovative specialty medicines that ensure efficacy, safety, and quality, providing patients with the best therapeutic options, as determined by their medical teams and/or healthcare professionals.​
    With a broad portfolio of proprietary specialty medicines, we operate in key therapeutic areas such as immunology, hematology, oncology, nephrology, infectious diseases, anesthesiology, and others.​


    We are structured into three business units: Onco-Hemato & Specialties, Pharma/Retail, and Aesthetics, each with its own commercial and marketing teams, as well as independent financial management.​