Trastuzumab Biosimilar Pipeline Development Service
Comprehensive Solutions for Trastuzumab Biosimilar Development
At Creative Biolabs, we specialize in providing comprehensive Trastuzumab biosimilar development services, utilizing our deep expertise in recombinant antibody technology and biosimilar manufacturing. Our services span the entire biosimilar pipeline, from early-stage characterization to large-scale production, ensuring your Trastuzumab biosimilar is of the highest quality and fully compliant with global regulatory standards.
Creative Biolabs is committed to supporting your Trastuzumab biosimilar project at every step, using cutting-edge technologies and a scientifically driven approach to navigate regulatory challenges. We ensure efficient development timelines, high consistency, and adherence to the highest quality standards, allowing you to bring a competitive and compliant Trastuzumab biosimilar to market.
- At a glance of Trastuzumab
Basic Information
Drug Type: Biosimilar, Monoclonal antibody
Synonyms: Trastuzumab Biosimilar (Aurobindo Pharma Ltd.); BP-02
Target: HER2
Action: Antagonists
Mechanism: HER2 antagonists (Receptor tyrosine-protein kinase erbB-2 antagonists); ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
Therapeutic Areas: Neoplasms; Skin and Musculoskeletal Diseases
Active Indication: Metastatic human epidermal growth factor 2 positive carcinoma of breast; HER2 Positive Breast Cancer
First Approval Date: European Union (30 Jun 2025), Metastatic human epidermal growth factor 2 positive carcinoma of breast
Most Recent Events
| Date | Events |
| 2025-07-01 | A new study shows that Trastuzumab biosimilars offer comparable efficacy and safety in the treatment of HER2-positive breast cancer. |
| 2025-03-25 | FDA grants approval for a subcutaneous formulation of Trastuzumab for metastatic breast cancer, offering patients an easier administration option. |
| 2024-12-15 | The European Medicines Agency (EMA) approves a new biosimilar of Trastuzumab for the treatment of HER2-positive gastric cancer. |
| 2024-09-20 | Phase III trial results confirm Trastuzumab's long-term effectiveness in combination with chemotherapy for HER2-positive breast cancer. |
| 2024-05-10 | Trastuzumab biosimilars receive approval in several new international markets, expanding access for patients with HER2-positive breast cancer. |
- Pipeline Status
Our Trastuzumab Biosimilar Pipeline Offers
Development Workflow of Trastuzumab Biosimilar Pipeline
| Early Development & Analytical Characterization | ||
| 1 | Sequence Analysis & Structural Characterization | Full sequencing of the reference Trastuzumab to identify and replicate its exact amino acid sequence and structural features, ensuring identical or highly similar binding and functional properties. |
| 2 | Cell Line Development | Creation of stable, high-yield mammalian cell lines (such as CHO or HEK293) optimized for large-scale biosimilar production. |
| 3 | Expression System Optimization | Selection of the most suitable expression system for efficient biosimilar production. This includes evaluating different vectors and culture conditions to maximize yield and product quality. |
| 4 | Glycosylation Profiling | Detailed analysis of glycosylation patterns to ensure that the biosimilar's post-translational modifications mirror those of the reference Trastuzumab. |
| 5 | Analytical Testing | Comprehensive testing for identity, purity, potency, and stability using techniques such as HPLC, mass spectrometry, and ELISA to verify that the biosimilar matches the reference product in terms of critical quality attributes. |
| Non-Clinical Development | ||
| 6 | In Vitro Biological Activity Testing | Functional assays, including ADCC (antibody-dependent cellular cytotoxicity), CDC (complement-dependent cytotoxicity), and receptor binding assays, to confirm that the biosimilar has the same therapeutic mechanisms of action as the reference product. |
| 7 | In Vivo Pharmacology & Toxicology | Animal studies to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of the biosimilar. |
| 8 | Immunogenicity Testing | Studies to assess the potential for anti-drug antibody (ADA) formation against the biosimilar, which could impact its safety and efficacy. |
| 9 | Biodistribution Studies | Evaluation of how the biosimilar distributes within the body and identifies any potential accumulation in specific tissues. |
- Available Packages
Creative Biolabs offers a comprehensive range of Trastuzumab biosimilar development service packages, designed to meet your specific needs at every stage of the development pipeline. Each package is tailored to provide optimal solutions, ensuring that your project progresses smoothly and efficiently while adhering to the highest industry standards. Below are the available packages:
| NO. | Item Name | Includes | Deliverables |
| 1 | Early Development & Analytical Characterization Package |
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| 2 | Non-Clinical Development Package |
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| 3 | Full Biosimilar Development Package |
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Each package is fully customizable to align with your specific project requirements, timelines, and budget, ensuring that you have the expertise and support necessary to bring your Trastuzumab biosimilar to market efficiently.
- Why Choose Us
Creative Biolabs stands at the forefront of Trastuzumab biosimilar development, offering specialized services designed to meet the needs of every stage of your project. Here's why you should choose us as your development partner:
Specialized Expertise
With years of experience in recombinant antibody development, our team brings unmatched knowledge and technical proficiency in creating high-quality biosimilars, particularly in Trastuzumab.
End-to-End Development Solutions
From early development through regulatory submission, we provide comprehensive services that cover the full biosimilar lifecycle, ensuring a streamlined process and effective project management.
Customer-Centric Approach
We offer tailored solutions to meet your specific needs, ensuring flexibility in both service offerings and timelines. Our dedicated project managers will keep you informed at every step, ensuring a transparent and smooth development process.
- Ready to Advance Your Trastuzumab Biosimilar Program
Ready to start your Trastuzumab biosimilar development or have further questions about our services? Our team is here to assist you with your project needs, from initial inquiries to full-scale development.
For more information, or to request a quote, please visit our website or fill out the contact form. Our team will respond promptly to assist with your Trastuzumab biosimilar development needs. Let us help you bring your product to market with confidence and efficiency.
For research use only. Not intended for any clinical use.
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