The Biologics Price Competition and Innovation Act (BPCIA) of 2010 (“Biosimilar Act”) serves as FDA’s current framework for biosimilars, but there is a great of deal of confusion surrounding this legislation and regulatory pathways for approval.
Outside the US, the global market has already evolved. The European Medicine Agency (EMA) has approved several biosimilar products to date including life-saving therapies that treat psoriatic arthritis, Crohn’s disease, psoriasis, rheumatoid arthritis, and chronic kidney failure. Its guidelines offer an excellent model for comparison.
What can we learn from what has worked and what hasn’t?
This 90-minute online course will give you an inside look at changing regulations, approvals, uncertainties, and opportunities to shed light on how your biopharmaceutical business should best adapt its approach. Examples of successful and unsuccessful submissions will be discussed, as well as major differences between US and EMA regulations and World Health Organization (WHO) guidelines.
By attending this course, you will learn:
- What the recent first US approvals mean to the regulatory and market landscape
- How to address Chemistry, Manufacturing & Control (CMC) regulatory challenges
- The current global regulatory landscape: Major differences in regulations
- Key factors when deciding between a biosimilar vs. a biobetter
- Assessing biosimilarity and interchangeability
- A case study: What one company learned from their competitive strategy