Key Considerations for Biosimilar R&D Workshop

The rapid rise in the number of biologic products, and their ever expanding health authority-approved indications, make biopharmaceuticals the most rapidly growing medicinal product segment for chronic diseases. Patent expirations for these novel biopharmaceuticals now allow opportunity for development of biosimilar products.

These biosimilars 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 the unique characteristics of individual biological products, regulatory challenges, manufacturing hurdles as well as challenges in understanding the needed data to establish a viable safe and effective product similar to the originator.

This comprehensive, high-level training program will provide a hands-on learning experience to those seeking to understand how a 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.

• Recognize key terminology associated with global biosimilar development
• Learn the current regulatory pathway from various health authorities
• Apply the current regulations and guidelines to establish product similarity
• Identify the strategic development steps to complete biosimilar development
• Recognize current challenges to development and commercialization of biosimilars in established as well as emerging markets

Professionals who work in the areas of:

• Biopharmaceutical R&D
• Quality and Manufacturing
• Regulatory Affairs
• Clinical and Nonclinical Safety
• Clinical Research, Development
• Medical Affairs
• Pharmacokinetics/Pharmacodynamics
• Business and Marketing Emerging Markets

Joe ZHANG, PhD

Joe ZHOU, PhD

Xiangyang ZHU, PhD

Michael YU, PhD