Abciximab Biosimilar Pipeline Development Service
Comprehensive Solutions for Abciximab Biosimilar Development
Abciximab is a chimeric monoclonal antibody fragment that targets the platelet glycoprotein IIb/IIIa receptor, effectively inhibiting platelet aggregation and reducing thrombotic events during percutaneous coronary intervention (PCI). With the original product's market exclusivity expired, biosimilar development represents a promising opportunity to increase accessibility and reduce healthcare costs in cardiovascular therapy.
Creative Biolabs offers fully integrated Abciximab biosimilar pipeline development services that span from early analytical characterization to pre-clinical manufacturing. Leveraging advanced monoclonal antibody engineering, robust comparability assessment, and cGMP manufacturing capabilities, we provide tailored solutions that comply with stringent EMA, and ICH guidelines, helping our clients navigate complex technical and regulatory challenges with confidence.
- At a glance of Abciximab
Basic Information
Drug Type: Fab fragment, Biosimilar
Synonyms: Abciximab biosimilar, Clotinab, ISU-301
Target: GP IIb/IIIa
Action: antagonists
Mechanism: GP IIb/IIIa antagonists(Integrin alpha-IIb/beta-3 antagonists)
Therapeutic Areas: Nervous System Diseases; Cardiovascular Diseases; Other Diseases
Active Indication: Angina Pectoris; Myocardial Infarction
Originator Organization: ISU Abxis Co., Ltd.
Inactive Organization: Janssen Global Services LLC
First Approval Date: South Korea (28 Dec 2006)
Most Recent Events
| Date | Events |
| Dec 28, 2006 | ISU Abxis received marketing approval in South Korea for Clotinab (ISU-301), an Abciximab biosimilar, indicated for myocardial infarction and unstable angina. |
| 2013 | Launch of an Abciximab biosimilar in India under a licensing agreement with Medicure, targeting cost-effective access in emerging markets. |
| Oct 2020 | Medicure secured licensing rights for Abciximab in the US, Canada, and EU, expanding its potential biosimilar footprint in major regulatory jurisdictions. |
| 2023–2024 | Continued advancements in CHO-based manufacturing platforms and analytical characterization methods for Abciximab biosimilars, enabling higher yield and improved process consistency. |
- Pipeline Status
Our Abciximab Biosimilar Pipeline Offers
Development Workflow of Abciximab Biosimilar Pipeline
| Early Development & Analytical Characterization | ||
| 1 | Reference Product Procurement & Profiling | Multiple lots of ReoPro are sourced to capture product variability. |
| 2 | Physicochemical Characterization | Primary sequence confirmation, disulfide linkage analysis, aggregation profiling, and glycosylation mapping. |
| 3 | Functional Assays Development | GP IIb/IIIa binding kinetics, platelet inhibition assays, and Fab fragment stability testing. |
| 4 | Cell Line & Process Development | High-expression stable CHO/HEK293 cell lines and optimization of upstream and downstream processes to match critical quality attributes (CQAs). |
| Non-Clinical Development | ||
| 5 | In Vitro Biological Activity Testing |
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| 6 | In Vivo Pharmacology & Toxicology |
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- Available Packages
We understand that Abciximab biosimilar development programs vary in scope, timelines, and regulatory requirements. To meet diverse client needs, Creative Biolabs offers flexible service packages — from focused early-stage analytical studies to full end-to-end development solutions. Each package is designed to comply with global regulatory guidelines and includes clear deliverables to facilitate decision-making and project advancement.
| NO. | Item Name | Includes | Deliverables |
| 1 | Early-Stage Development & Comparability Studies |
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| 2 | Preclinical Proof-of-Concept & IND-Enabling Studies |
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| 3 | Full-Service End-to-End Package |
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- Why Choose Us
Choosing the right partner for Abciximab biosimilar development can significantly influence the speed, quality, and success of your program. Creative Biolabs combines scientific excellence, regulatory insight, and tailored project management to deliver solutions that go beyond conventional service offerings.
Extensive Expertise in Antibody Biosimilars
With years of hands-on experience in developing complex biologics, our team has a deep understanding of the structural and functional nuances of Abciximab, particularly its Fab fragment format and GP IIb/IIIa receptor binding mechanism.
Comprehensive End-to-End Capabilities
From early analytical characterization and cell line development, we provide a fully integrated service platform, minimizing handover risks and ensuring seamless project continuity.
State-of-the-Art Analytical Platforms
Our advanced bioanalytical technologies enable precise comparability studies, including high-resolution mass spectrometry, advanced chromatography, bioassays, and platelet aggregation testing that meet stringent regulatory expectations.
- Ready to Advance Your Abciximab Biosimilar Program
Creative Biolabs stands ready to accelerate your biosimilar journey with comprehensive, reliable, and high-quality Abciximab biosimilar development services. From characterization to commercialization, our expert team ensures scientific rigor and regulatory confidence at every step.
Contact us today for a personalized consultation and proposal to propel your Abciximab biosimilar program forward.
For research use only. Not intended for any clinical use.
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