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Comparability studies

Agile BioScience understands the rigor required for successful biosimilar development. Our comprehensive testing capabilities support extensive comparability studies, accelerating your path to market and ensuring your biosimilar meets the highest quality, safety, and efficacy standards.

The Importance of Comparability Studies

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• Regulatory Requirement: Demonstrating similarity to the Innovator molecule is a key pillar of biosimilar approval.

• Quality Assurance: Thorough comparability exercises ensure your biosimilar matches the originator's established safety and efficacy profile.

• Confidence for Prescribers & Patients: Well-conducted comparability testing builds trust in your biosimilar's performance.

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Our Biosimilar Testing Expertise

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• We offer a comprehensive range of structural, biophysical and physicochemical characterization methods drawing on years of technical expertise and product insight to tailor these to your needs.

• Method development, optimization and routine analysis.

• Deep Regulatory Understanding: Our team interprets guidelines (FDA, EMA, ICH) to design robust comparability studies aligned with regulatory expectations.

• Collaborative Approach: We work closely with you to tailor testing plans, ensuring they address your specific biosimilar and target market.

• Data-Driven Guidance: We provide actionable insights throughout the process, supporting strategic decision-making.

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Why Choose Agile Bio-Science:

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• Accelerated Timelines: Our expertise and streamlined protocols expedite your comparability studies.

• Cost-Effectiveness: Right-sized testing plans balance thoroughness with efficiency.

• Scientific Rigor: Ensure your biosimilar's quality attributes, safety, and efficacy are rigorously demonstrated.

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Contact us to discover how our biosimilar testing services can propel your product's success.