Remsima Case Study – The importance of ADCC in assessing clinically relevant differences

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.

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