Biosimilars

Biosimilars Drug Development Services

IDDI has been managing clinical trials for biosimilars since the very beginning, and is well-entrenched in the biosimilars market. IDDI leverages a cross-functional team of experts, including therapeutic specialists, operational experts and regulatory consultants who will partner with you to develop the optimal clinical drug development and strategy to maximize the value of your biosimilar clinical trial.

Biosimilars are highly similar and less costly alternatives to drugs known as biologics, whose patents have expired.  They require rigorous clinical trials methods to gain regulatory approval. – “Each new biosimilar has to run clinical trials to prove the outcome matches that of the biologic it’s imitating even though it looks structurally different” FDA Guidelines. While clinical requirements differ by regulatory agency, in general, two phases of clinical studies are required for biosimilars – a Phase I  to demonstrate similar pharmacokinetics (PK) and pharmacodynamics (PD), and a Phase III  to demonstrate similar efficacy, safety and immunogenicity to the reference biologic.

Expertise In Biosimilars

We are currently involved in 11 clinical trials on biosimilars – mainly the second generation of monoclonal antibodies – in cancer research, musculoskeletal and endocrine diseases.

ASSESSMENT OF BIOSIMILARS REQUIREMENTS INCLUDES:

  • Understanding the mechanism of action
  • Valid pharmacodynamic assays
  • Comparative immunogenicity
  • Experience with the reference biologic
  • Comparative pharmacokinetics (equivalence)
  • Comparative clinical data (non-inferiority)

IDDI as an expert in the field of Biosmilars:

  • Even though there is ongoing alignment between the regulatory authorities, there are still differences in the interpretation of the FDA and EMA 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, but IDDI is ready to take on this challenge with confidence.