It's been less than three years since the first biosimilar launched in the U.S., yet analysts are reporting that the worldwide biosimilar market will reach $90 Billion over the next 10 years. While the market has high expectations for biosimilars, for drug developers, the path toward regulatory approval and commercial success can be filled with unique challenges.
Join Cardinal Health Specialty Solutions as we review the biosimilar landscape and identify key strategies for overcoming regulatory barriers and getting your biosimilar to market quickly. Key objectives for the webinar include:
- Understand the rationale for developing biosimilars in the US healthcare market
- Review the FDA regulatory requirements to develop biosimilars and discuss the general design of clinical trials that drug developers need to consider as they develop biosimilars.
- Identify common pitfalls that developers of biosimilars products may encounter during the regulatory process
- Explore the concept of “extrapolation” and discuss its advantages and disadvantages
- Share primary level market research data from community-based oncologists and rheumatologists on their views about prescribing biosimilars and potential barriers to adoption.