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Biosimilar Development: Strategies and Regulatory Requirements for Global Market Entry


Overview

Do you have a strategy for biosimilar development? Extensive use of biologic products have become the mainstay in personal treatment regimens across an ever increasing array of disease states including cancer, diabetes, various forms of arthritis, Chron’s disease and multiple sclerosis. The prohibitive cost of these novel biopharmaceuticals have restricted broader introduction to populations across the globe.  Patent expirations for these biopharmaceuticals offer new opportunities to introduce cost effective alternatives to a greater number of patients.
These follow-on biologics have garnered great interest for their cost-effective benefits in patient care as well as development opportunities for sponsors who see a new revenue stream.  However, the pathway to commercialization is complicated by regulatory challenges, manufacturing hurdles as well as challenges in understanding the needed data requirements to establish a viable safe and effective product compared to the originator. 
This comprehensive, high-level training program will provide a tailored learning experience to those seeking to understand how a follow-on biologic or candidate biosimilar product is developed, regulated and registered for global commercialization. Information will also be provided on remaining issues yet to be resolved that may further complicate successful integration of biosimilars into common therapeutic practice. Information on global market status of follow-on biosimilars, governing regional regulations and pending issues facing further global commercialization will be reviewed.
Course Level:  Intermediate

What you will learn

  • Understanding the “similar but not identical” paradigm
  • The current global regulatory environment
  • Components of strategic biosimilar development
    • CMC/Quality requirements
    • Need for preclinical evaluation
    • Clinical efficacy study requirements
    • Comparative PK/PD exercise
  • Challenges to development and market entry

Who should attend?

Professionals who work in the areas of:

  • Business and Marketing
  • Clinical Research and Development
  • Medical Affairs
  • Regulatory Affairs
  • Pharmacokinetics/Pharmacodynamics
  • Emerging Markets
  • Chemistry and Manufacturing

Learning objectives

At the conclusion of this course participants should be able to:

  • Identify the strategic development steps to complete biosimilar development
  • Describe the current regulatory pathway from various health authorities
  • Discuss the specific requirements to establish  similarity compared to an established reference product
  • Recognize current challenges to development and commercialization of biosimilars in established as well as emerging markets