Clinical Assessment of Biosimilars


Expert guidance through the complex biosimilar development and regulatory process

Expertise Built From Working with Innovator Biologic Drugs

With over 25 years of biologics drug development experience, Celerion provides an extensive list of bioanalytical assays, clinical study conduct expertise, data analysis capabilities and regulatory expertise for successful development of a biosimilar drug. Celerion is well known for immunogenicity assessment of large molecule drugs including development and validation of anti-drug antibody assays and neutralizing antibody assays. Cell-based functional assays and specific biomarker assays contribute to the pharmacodynamic assessment of certain biosimilars. From PK bioequivalence to assessment of similarity of effect in patients, Celerion can provide all the required services for successful clinical studies supporting biosimilar marketing applications.

 


Experts in Immunogenicity, Antigenicity and Immunotoxicology

Demonstrating that a biosimilar has similar or less immunogenicity than the innovator is an important element of biosimilar development. Celerion’s extensive experience and expertise in immune system evaluation enables you to rapidly assess the impact of possible immunological adverse effects in humans and tox species. Our bioanalytical laboratories use state-of-the-art technology to detect if antibodies are generated to biosimilars, and also determine if the antibodies are neutralizing. Your results are quickly delivered since our capacity gives us the ability to analyze over 15,000 samples per month.

 


Impeccable Clinical Study Designs

We leverage our experience built through years of analyzing bioequivalence and bioavailability of drugs to design appropriate comparative studies to establish biosimilarity with marketed reference drugs. Expert knowledge of pharmacodynamic markers of effect is a powerful tool to further establish similarity for specific drugs and potentially avoid large studies in patients.

  • Our experienced regulatory team helps you execute efficient regulatory strategies and provides tactical support to ensure timely communication and quality submissions
  • Bioanalytical scientists, with over 30 years’ experience, work with all classes of biopharmaceuticals and biosimilars
  • One stop for PK/PD assessment of biological products in healthy subjects and patients
  • Only CRO with global harmonized electronic laboratory notebook in both state-of-the-art laboratories located in Zurich, Switzerland and Lincoln, NE that ensures high quality execution of assays that meet or exceed GLP and ICH expectations.

Turn-key Biosimilar Solutions

We provide a complete program for clinical development and registration for specific assays

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