Biosimilar Development Webinar

Description

The development pathway of a biosimilar is unlike that of a novel biotherapeutic. While there is an increased requirement for analytics throughout a biosimilars development project, and a Phase II clinical trial is generally omitted, careful consideration must be given to the planning of the other phases of development. Many regulatory authorities reference a “step-by-step” approach to establishing biosimilarity.

This hour-long webinar will provide a look at the multi-stage development for a biosimilar, including a review of the regulatory landscape, structural characterization techniques for biosimilarity assessment, and early phase clinical research challenges

• Examine prevailing regulatory requirements
• Provide appropriate analytical data particularly for antibodies where their size and complexity requires LC/MS/MS approaches
  • Establish the Quality Target Product profile (QTTP)
  • Strategies for primary and higher order structure determination of glycoproteins, including PTMs
  • Comprehensive physicochemical structural characterization to demonstrate “Biosimilarity” with the originator
• Meet the challenges of early phase clinical research studies in biosimilars
  • Comparative clinical studies – a stepwise approach, including regulatory requirements
  • Clinical trial considerations, strategies and implementation of operational solutions

Presenters