The Biosimilars Landscape: What All Developers Need to Know
As biosimilars to treat rheumatic diseases begin get approval from the FDA, biosimilar development remains a hot topic in drug development. Sponsors estimate a 35% growth of biosimilars in their development pipelines by 2020, but face a wide variety of regional and global markets along with shifting guidelines and recommendations, stressing the need to understand this rapidly changing landscape. What is the real potential for clinical and health-economic benefits offered by these agents?
Driving effective, efficient and fit-for-purpose clinical trial designs requires an acute understanding of the varying nuances in targeted regional areas as compared to the global marketplace, as well as a strategy to drive successful post-approval commercialization across a range of biosimilar markets.
Join this webinar to develop a deeper understanding of the current biosimilars landscape, the typical development pathway and key regulatory issues expected over the next five years. From discovery to commercialization, you’ll learn about the end-to-end considerations and strategies that will help advance biosimilars in rheumatology.
- Learn about the current regional and global biosimilar landscape
- Get an overview of the biosmilar development pathway and upcoming regulatory issues
- Understand the key clinical issues associated with biosimilars
- Hear crucial market access considerations for biosimilar development
Presented by:
- Mark P. Fletcher, MD – Executive Medical Director, Inflammation, Infectious Diseases and General Medicine
- Alicia M. Baker – Director, Global Regulatory Affairs Strategy
- John Carlsen, MHA – Vice President, Market Access Services