Scientific ADA/PK Testing in Biosimilars: Value and Industry Trends

Release date: 2025-10-21 View count: 21

Unlocking Opportunities in Biopharmaceutical Research

The global biopharmaceutical industry is advancing rapidly, with biosimilars driving innovation in antibody-based therapies and complex biologics. According to the IQVIA 2025 report, the biosimilar market is expected to surpass $74 billion by 2030. As patents expire, the demand for research intensifies, with anti-drug antibody (ADA) and pharmacokinetic (PK) testing playing critical roles.

Referencing ICH Q6B, our assay kits align with quality control standards, offering robust solutions for research methodology development.

Flowchart of biopharmaceutical development, from experimental design to data analysis

Figure 1: Biopharmaceutical Development Workflow

Understanding Biosimilars and Detection Methods

Biosimilars are biologics closely resembling reference products in structure, function, and quality, requiring comparative data to confirm similarity. Our assay kits are designed to meet FDA and EMA standards for sensitivity and specificity in biologic testing.

ADA Testing identifies anti-drug antibodies using a three-tier approach (screening, confirmation, titration), enabling long-term sample analysis for up to six months. abinScience’s ELISA-based bridging assays leverage biotinylated drugs and HRP-labeled antibodies for high-sensitivity detection of antibody-drug complexes.

Competitive assays target neutralizing antibodies, ideal for specific activity studies.

ADA testing process, illustrating screening, confirmation, and titration stages

Figure 2: ADA Testing Process (DOI: 10.1038/s41598-021-95055-x)

PK Testing measures drug exposure (Cmax, AUC, t1/2) to support immunogenicity and PK studies in biopharmaceutical research. Our kits, optimized for ELISA platforms, align with bioequivalence standards (e.g., 80%–125% confidence intervals), adaptable to specific experimental designs.

Charge heterogeneity comparison in ADA testing for biosimilars, showcasing analytical precision

Figure 3: Charge Heterogeneity in ADA Testing for Biosimilars (DOI: 10.1007/s13205-020-02506-9)

Critical Standards for ADA/PK Testing

Based on FDA, EMA, and ICH guidelines, the following technical metrics optimize ADA/PK testing for robust experimental outcomes:

Test Type	Key Metric	Description
ADA	False Positive Rate < 1%	Ensures high specificity, minimizing false positives
ADA	Positive Detection Rate > 95%	Maximizes sensitivity to detect immune responses
PK	Linear Range 0.1–1000 ng/mL	Supports broad concentration ranges with R² > 0.99
PK/ADA	CV < 10%	Ensures batch-to-batch reproducibility, validated on ELISA
PK/ADA	Cross-Reactivity < 0.5%	Guarantees assay specificity

Cutting-Edge High-Throughput Detection

Recent advancements emphasize standardized ADA testing and platform consistency, enabling reliable long-term sample tracking.

Our ELISA-based solutions offer exceptional sensitivity (LOD < 0.1 ng/mL) and reproducibility (CV < 5%), making them ideal for complex biopharmaceutical research (Frontiers in Drug Development, 2024).

Figure 4: Integrated Framework for Biosimilar ADA/PK Testing and Clinical Evaluation (Source: FDA BsUFA III Research Pilot)

abinScience ADA/PK Assay Kits

Our ISO 13485-certified ADA/PK assay kits are tailored for research-use ELISA platforms, delivering reliable data for immunogenicity and PK studies.

Key benefits include:

Unmatched Sensitivity for Precise Detection
ELISA-Optimized with Inter-Batch CV as Low as 7.8%
Support for Major Targets: Adalimumab, Rituximab, Trastuzumab, and More
Custom CRO Testing and Target-Specific Development, Delivered in < 4 Weeks
Global Cold-Chain Distribution Across Asia-Pacific, Europe, and the Americas

Explore our range of ADA and PK assay kits below:

Type	Catalog No.	Product Name	Sample Type	Sensitivity	Range
ADA Assay Kits	AY583018	Anti-Tocilizumab ELISA Kit	Plasma, Serum	—	156.25–10,000 ng/mL
	AY583518	Anti-Tocilizumab Neutralizing Antibody ELISA Kit	Plasma, Serum	—	15.625–1,000 ng/mL
	AY596018	Anti-Natalizumab ELISA Kit	Plasma, Serum	—	156.25–10,000 ng/mL
	AC669018	Anti-Rosopatamab ELISA Kit	Plasma, Serum	—	7.81–500 ng/mL
	AF879018	Anti-Adalimumab ELISA Kit	Plasma, Serum	83.1 ng/mL	156.25–10,000 ng/mL
	AV466018	Anti-Mirikizumab ELISA Kit	Plasma, Serum	—	156.25–10,000 ng/mL
	AV466028	Anti-Guselkumab ELISA Kit	Plasma, Serum	—	156.25–10,000 ng/mL
	AF879068	Anti-Golimumab ELISA Kit	Plasma, Serum	85.1 ng/mL	156.25–10,000 ng/mL
	AS870018	Anti-Nivolumab ELISA Kit	Plasma, Serum	—	156.25–10,000 ng/mL
	AS739018	Anti-Tiragolumab ELISA Kit	Plasma, Serum	10.11 ng/mL	156.25–10,000 ng/mL
	AY286028	Anti-Pertuzumab ELISA Kit	Plasma, Serum	—	156.25–10,000 ng/mL
	AY286518	Anti-Pertuzumab Neutralizing Antibody ELISA Kit	Plasma, Serum	—	15.625–1,000 ng/mL
	AB769018	Anti-Ustekinumab ELISA Kit	Plasma, Serum	—	156.25–10,000 ng/mL
	AF879038	Anti-Certolizumab ELISA Kit	Plasma, Serum	—	156.25–10,000 ng/mL
PK Assay Kits	DF996018	Basiliximab ELISA Kit	Plasma, Serum	13.31 ng/mL	23.44–1,500 ng/mL
	DY286028	Pertuzumab ELISA Kit	Plasma, Serum	0.156 µg/mL	0.31–5 µg/mL
	DB941018	Bevacizumab ELISA Kit	Plasma, Serum	98.1 ng/mL	312.5–20,000 ng/mL
	DB949018	Bimagrumab ELISA Kit	Plasma, Serum	97.28 ng/mL	125–4,000 ng/mL
	DB941028	Brolucizumab ELISA Kit	Plasma, Serum	—	1.5625–100 ng/mL
	DK565028	Casirivimab ELISA Kit	Plasma, Serum	—	15.625–1,000 ng/mL
	DY403028	Concizumab ELISA Kit	Plasma, Serum	0.156 µg/mL	0.31–5 µg/mL
	DB732018	Dupilumab ELISA Kit	Plasma, Serum	—	78.125–5,000 ng/mL
	DK565038	Imdevimab ELISA Kit	Plasma, Serum	—	15.625–1,000 ng/mL
	DB885028	Inclacumab ELISA Kit	Plasma, Serum	5.67 ng/mL	31.25–2,000 ng/mL
	DS856038	Ixekizumab ELISA Kit	Plasma, Serum	39.3 ng/mL	78.13–5,000 ng/mL
	DC359018	Magrolimab ELISA Kit	Plasma, Serum	48.26 ng/mL	62.5–4,000 ng/mL
	DK421018	Nirsevimab ELISA Kit	Plasma, Serum	13.72 ng/mL	46.88–3,000 ng/mL
	DC669028	Rosopatamab ELISA Kit	Plasma, Serum	63.23 ng/mL	468.75–30,000 ng/mL
	DY373018	Sacituzumab ELISA Kit	Plasma, Serum	40.3 ng/mL	78.13–5,000 ng/mL
	DK565018	Sotrovimab ELISA Kit	Plasma, Serum	—	156.25–10,000 ng/mL
	DV243018	Tezepelumab ELISA Kit	Plasma, Serum	0.156 µg/mL	0.31–5 µg/mL
	DY286038	Trastuzumab ELISA Kit	Plasma, Serum	70.12 ng/mL	78.13–5,000 ng/mL
	DC336018	Urelumab ELISA Kit	Plasma, Serum	18.73 ng/mL	31.25–2,000 ng/mL

Discover ADA/PK Testing Solutions

Market Trends and Research Opportunities

Driven by global healthcare cost pressures and biotechnology advancements, the biosimilar market is expanding rapidly. Forecasts predict a market size exceeding $74 billion by 2030, with antibody-based biosimilars (e.g., anti-TNF-α, anti-IL-6R) leading growth. The post-patent era for drugs like Adalimumab, Trastuzumab, and Bevacizumab is fueling innovation among research institutions and biopharma companies.

ADA and PK testing are pivotal in drug evaluation, supporting preclinical, regulatory, and mechanistic studies, as well as cross-regional comparisons. The demand for reproducible, sensitive, and standardized data is rising, cementing ELISA as a cornerstone platform for biosimilar research.

Customized ADA/PK assay kits are increasingly preferred by CROs, biopharma, and academic researchers for high-throughput analysis and diverse experimental needs, empowering global collaborations and regulatory data preparation.

Figure 5: 2023-2030 Biosimilar Market Size Forecast (USD Billion)

About abinScience

Founded in Strasbourg, France, abinScience is a biotechnology company dedicated to advancing biopharmaceutical research through high-sensitivity, ISO 13485-certified ADA/PK assay kits optimized for ELISA platforms.

Leveraging Strasbourg’s vibrant innovation ecosystem, we serve academic researchers, CROs, and biopharma companies worldwide, driven by our mission to empower scientific discovery.

Learn More About Our Mission

Get in Touch

Email us at: support@abinscience.com

References

IQVIA. (2025). Unlocking Biosimilar Potential: Learnings from an Osteoporosis Case Study of Complex Patient Pathways. iqvia.com
FDA. (2019). Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody Detection. fda.gov
EMA. (2014). Guideline on Similar Biological Medicinal Products (CHMP/437/04 Rev.1). ema.europa.eu
Frontiers in Analytical Science. (2024). Novel and rapid analytical platform development enabled by 3D printing. frontiersin.org
ICH Q6B. (1999). Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. database.ich.org

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