IDDI, Biostatistical and eClinical Services for Clinical Trials

TRIAL DESIGN - RANDOMIZATION - DATA MANAGEMENT - BIOSTATISTICS
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Biosimilars

 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 Expertise

  • 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 modelhow 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)