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.


The Biosimilar AllianceSM

The Biosimilar Alliance is a partnership between Celerion and Ricera Biosciences to bring together the expertise to guide clients through the complex, biosimilar development process. The alliance leverages over 20 years of experience in biologics drug development to enable early assessment of biosimilar viability, and to bridge the gap between newly sourced products and patient studies. Spanning ad hoc consulting services to full program development; from preclinical to pivotal clinical studies, services of the alliance include:

  • Early safety and PK assessment of biologic drug candidates in animals and humans
  • Extensive experience in developing and validating assays of human insulins, interleukins, interferons, pegylated interferons, erythropoetins, monoclonal antibodies and fusion proteins
  • Immuno-toxicology expertise within Europe’s largest Non-Human Primate (NHP) research facility
  • Extensive expertise in the monitoring and quantification of antigenicity (antidrug antibodies) in animal and human samples from clinical studies
  • PK/PD assessment of biological products in patients and healthy volunteers
  • Regulatory expertise to guide full biosimilar development programs

Turn-key Biosimilar Solutions

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

Learn More

The Biosimilar AllianceSM

A partnership to guide you through the complex, biosimilar development process.

Learn More


Translating Your Science to Medicine.

Partner with us to get fast, actionable data you can rely on.

Contact Us

Related to "Biosimilars"