Remsima Case Study: The importance of ADCC in assessing clinically relevant differences
Authors: Dr. Daniel Galbraith, Chief Scientific Officer and Andy Upsall, Director of Technical Services – BioOutsource Ltd.
The Regulatory Authorities Verdict
“Biosimilars have caused a revolution in the development of biologic drugs. The model for biosimilars is a combination of speed to market and low cost; these are fundamental to any biosimilar development project. The biosimilars pathway to approval is not always without difficulty, biosimilars are still relatively new, and as each new applicant is reviewed we are learning more and more about these molecules. One area of interest recently has been the subject of extrapolation of data from one clinical trial within a specific indication to one or more alternative indications. This will become more and more critical as manufacturers seek to maximise the potential patient population and recoup development costs as new versions of the biosimilars enter the market. The approval of the first biosimilar monoclonal antibody, Infliximab, REMSIMA™/INFLECTRA™, in 2012 represented a significant milestone, welcomed by the biosimilar industry and patients alike. This was the world’s first monoclonal antibody biosimilar approved for a developed market. There have, however, been some issues with how different regulators have viewed this product; The European Union  Korean FDA , Health Canada  and the Japanese Ministry of Health  have adopted different positions on the extent that extrapolation can be applied, whilst the FDA have not made their position clear (Fig. 1).” – Extract from Case Study
Download the Case Study now to find out more about:
- The Regulatory Authorities Verdict
- Antibody Dependent Cell Mediated Cytotoxicity (ADCC)
- The relevance of ADCC activity to Remicade’s clinical efficacy
- When should ADCC potential be evaluated?
- Attributes that confer ADCC Activity
- Optimal ADCC Methods: Orthogonal and Sensitive
- Biologically relevant ADCC Methods
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