Biosimilar

Adalimumab Biosimilar Pipeline Development Service

Comprehensive Solutions for TNF-α-Targeted Biosimilar Development

Creative Biolabs offers comprehensive support for Adalimumab biosimilar development, guiding clients from early-stage characterization to final regulatory submission. Leveraging deep expertise in antibody engineering and TNF-α inhibition, we deliver scientifically robust and regulatory-compliant solutions to streamline biosimilar advancement. Our integrated approach ensures efficient progression through each phase, from structural analysis to pre-clinical validation, reducing time-to-market while maintaining stringent quality standards.

At a glance of Adalimumab

Service Overview

Adalimumab is a fully human monoclonal antibody designed to target and neutralize tumor necrosis factor-alpha (TNF-α), a pro-inflammatory cytokine implicated in various autoimmune disorders such as rheumatoid arthritis, inflammatory bowel disease, and plaque psoriasis. By binding to soluble and membrane-bound TNF-α, it effectively disrupts inflammatory signaling cascades, alleviating symptoms and slowing disease progression. As the first human-derived anti-TNF biologic, it offers reduced immunogenicity compared to earlier murine-based therapies. Since its approval in 2002, adalimumab has revolutionized autoimmune treatment, with biosimilars subsequently developed to enhance treatment accessibility. Administered subcutaneously, it combines therapeutic efficacy with patient convenience, though its immunosuppressive effects require vigilant monitoring for infections.

Basic Information

Drug Type: Monoclonal antibody

Synonyms: Adalimumab (Genetical Recombination), Raheara, ABT-D2E7

Target: TNF-α

Action: Inhibitors

Mechanism: TNF-α inhibitors(Tumor necrosis factor α inhibitors)

Inactive Indication: Asthma; Axial Spondyloarthritis; Chronic large plaque psoriasis

Originator Organization: AbbVie, Inc.

Inactive Organization: Abbott Laboratories; Abbott Laboratories Ltd.; Eisai Co., Ltd.

First Approval Date: United States (31 Dec 2002)

Most Recent Events

Date	Events
07 May 2025	Teva Reports Ninth Consecutive Quarter of Growth in Q1 2025 With Key Innovative Medicines Growing ~40%; 2025 Profit Outlook Improved
05 May 2025	Teva and Alvotech Announce Approval of Interchangeability for SELARSDI™ (ustekinumab-aekn) with Stelara® (ustekinumab)

Pipeline Status

Our Adalimumab Biosimilar Pipeline Offers

Fig.1 Adalimumab Biosimilar Pipeline. (Creative Biolabs Original)

Development Workflow of Adalimumab Biosimilar Pipeline

Early Development & Analytical Characterization
1	Feasibility & Planning	Strategic evaluation of market potential and IP status Procurement and preliminary analysis of the reference product Regulatory pathway consultation based on target regions
2	Analytical Characterization	Detailed physicochemical profiling: molecular weight, charge variants, glycosylation Structural analysis: peptide mapping, disulfide bonds, higher-order conformation Functional assays: TNF-α binding, neutralization potency, Fc receptor interaction
3	Cell Line Development	CHO-based stable cell line generation with optimized expression Clone screening, productivity assessment, and genetic stability testing Establishment of GMP-compliant Master and Working Cell Banks
4	Process Optimization	Upstream development: culture media, feeding strategies, and bioreactor parameters Downstream purification: chromatography steps and impurity clearance
5	Formulation Design	Buffer system and excipient selection to match reference product stability Compatibility testing with delivery devices (e.g., syringe, pen injector) Accelerated and long-term stability studies
Non-Clinical Development
6	Preclinical Evaluation	In vitro functional validation (e.g., bioassays, ADCC if applicable) In vivo pharmacokinetic and toxicological assessment in suitable models Immunogenicity testing and dose-response analysis

Available Packages

Creative Biolabs provides adaptable and customizable service packages tailored to your Adalimumab biosimilar development requirements. Whether you're starting with comparability studies or advancing towards regulatory submission, you can select the package that aligns with your current stage or work with us to create a bespoke solution.

Items	classification	What we can offer
1	Antibody Product	Fully characterized Adalimumab biosimilar antibodies available in both research-grade and GMP-grade formats, suitable for various applications like bioassays, stability testing, and preclinical research.
2	Cell Line	Stable, high-expression CHO cell lines designed for Adalimumab biosimilar production. We provide detailed records of clone screening, productivity data, and master/working cell bank documentation.
3	Analytical Data	Physicochemical Characteristics Structural Integrity Functional Activity Purity & Impurity Profiles Non-Clinical Data In vitro functional assay results (e.g., neutralization, apoptosis induction) In vivo pharmacokinetic and toxicology studies in relevant animal models Immunogenicity profiles and dose-range finding studies

Why Choose Us

Expertise Across All Stages

From early analytical testing to preclinical trials, we offer end-to-end solutions for Adalimumab biosimilars with unmatched scientific precision and regulatory expertise.

Tailored, High-Quality Solutions

Our flexible service packages are designed to meet your specific needs, providing GMP-grade antibodies, stable cell lines, and comprehensive data at every development stage.

Efficient & Reliable Process

With streamlined workflows and a proven track record, we accelerate your development timeline while ensuring quality and regulatory compliance at each step.

Ready to Advance Your Adalimumab Biosimilar Program

Get in touch with us to craft a tailored development plan that meets your regulatory requirements and project timelines. Contact us today for a quote, to schedule a consultation, or to download our service brochure.

For research use only. Not intended for any clinical use.

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