IDDI is currently involved in 10 clinical trials of biosimilars, mainly the second generation of monoclonal antibodies.
Assessment of biosimilar requests includes:
• Understanding of mechanism of action
• Valid pharmacodynamic assays
• Comparative immunogenicity
• Experience with reference biologic
• Comparative pharmacokinetics (equivalence)
• Comparative clinical data (non-inferiority)
IDDI is thoroughly familiar with the above areas which positions IDDI as an expert in this field.
Even though there is ongoing alignment between the regulatory authorities, there are still differences in the interpretation of the regulations which IDDI clearly understands.
There is no global definition of what must be done for each trial as this is assessed on a study-by-study basis and is another area where IDDI can assist Sponsors to find the best approach.
This assistance will be in the area of study design, sensitive disease model, how to measure similarity through endpoints and equivalence margins, safety assessments and immunogenicity testing.
The choice of non inferiority margins is a challenge, and linked to that is the sample size calculation as well, but IDDI is ready to take on this challenge with confidence.
IDDI Experience in Biosimilar (% of Clinical Trials over the last 5 years)