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Lean and Mean Biosimilar Trial Design

Petra M. Roos, MSc., PMP

Sr. Director, Project Management Biosimilars and Biotech, Clinical Research Services

Lean, Mean and Innovative for cost effective and expedited time to market

Biosimilars have the potential to increase patient access to essential biologic treatment options, as they can be developed via an abbreviated pathway compared to the originator product. As of Aug 18, the FDA has approved twelve biosimilar medications under the Biologics Price Competition and Innovation Act (BPCI Act) of 2009, which was passed in an effort to reduce costs and increase access to biologics, with the first one being approved in 2015. EMEA has approved 50 biosimilars, since 2006.

Competition is fierce between large pharmaceutical and biotechnology companies that are investing in the biosimilar market, and it is expected that the number of biosimilars being developed will continue to increase dramatically as more biologics come off patent. To have the competitive edge it is essential to design the trial to firstly meet the requirements for BLA/MAA approval but also excludes any features that negatively impact on the speed of execution and ultimately the cost of the trial.

Recent experience in biosimilar clinical trials shows that strategic planning and a few simple tactics can increase return on investment and expedite time to market for biosimilars;

  • Protocol design that meets regulatory requirements and considers the implications of increasing the complexity and volume of data collated.
  • Patient recruitment strategies focused on regions where patients can benefit from the availability of biosimilars through clinical trials
  • Sourcing and planning the availability of comparator drug to ensure that delays do not impact on key milestone targets and the smooth running of trial.
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