- Demonstrating biosimilarity and clinical outcome



Biosimilars are biological medical products that are highly similar to already approved innovator drugs. In biosimilar development, the main goal is to demonstrate similarity to the innovator product in key areas, such as pharmacokinetics, pharmacodynamics and evaluation of efficacy, safety and immunogenicity in clinical studies.

Let us help accelerate your small biosimilars drug development project!

Contact us to discuss your project with our scientists today! 

Contact Us

With many of the existing patents of biological therapeutics blockbuster drugs set to expire in the next few years, the development of biosimilars has become increasingly important.

However, extensive requirements for analytical characterization is needed to show comparability between innovator and biosimilars. It must be proven that “the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components” and that “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency”. 


Demonstrating sufficient similarity between compounds to establish identical clinical outcomes

Common challenges when developing Biosimilars

  • Bioanalytical program design (i.e. assay design, what to validate, how to do samples analysis etc.)
  • Clinical significance of identified differences
  • Challenges in obtaining critical reagents e.g. positive control antibodies for ADA/NAb, suitable cell line

We know how to navigate the challenges of biosimilar drug development

We can help to put processes in place for PK/immunogenicity biosimilar assay design and validation aspects. We also have experience in biosimilar bioanalytical development/validation and sample analysis.


Assist in the strict comparability regime to show similarity & safety

We offer service and expert knowledge within the following application areas:

  • Pharmacokinetics (PK)
  • Immunogenicity (ADA, NAbs)
  • Biomarker sample analysis
  • Consultancy Services
    • Design of bioanalytical biosimilar program strategy
    • Assay development/validation of PK/ADA/NAb assays that are fit-for-purpose for biosimilar assessments
    • PK/ADA/NAb sample analysis in biosimilar trials
    • In-house off-the-shelf solutions available for NAb assays
    • Utilize  synergy for consolidating the immunogenicity programs
    • Solutions for generating critical reagents such as custom cell lines (iLite), if not available off-the-shelf
    • Solutions for generating critical reagents such as positive controls for ADA/NAb, through our collaboration partner