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SPONSORED SESSION: Case Study Spotlight hosted by Similis Bio: A Distributed Innovator Data Collection Approach to Expedite Biosimilar Development
Session Chair(s)
Brad Prater
Director, Product and Process Development
Similis Bio, United States
*This course requires a Separate RSVP.
Case Study Spotlight hosted by Similis Bio: A Distributed Innovator Data Collection Approach to Expedite Biosimilar Development
In contrast to developing a new biological entity where mechanism of action and clinical efficacy are leading indicators of long-term success, development of a biosimilar relies heavily on analytical characterization of both the innovator and biosimilar products. Regulatory guidance on carrying out similarity or comparability studies has recommended carrying out all testing of product lots side by side to minimize variability and increase the robustness of the data set. In this talk, a novel lifecycle approach to generating comprehensive data sets for both functional and physiochemical methods will be presented, relying on continuous sourcing of innovator material early and often in the product’s lifecycle. By using data sets generated across a wide time scale, the true variation in both the innovator and biosimilar quality attributes can be determined resulting in appropriate specification setting for production. Case studies will be presented for biosimilar products under development.
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