Who are we?
The guidelines and standards for evaluating biosimilar medicines vary in different regions and countries around the world. The Center for Biologic Policy Evaluation, or CBPE, was established as an independent organization to impartially evaluate these regulatory policies, measured against global standards set forth by the World Health Organization.
Our board is made up of experienced regulators, with deep expertise in biologics and biosimilars. Our Executive Director is Philo D. Hall, JD. Learn more about Mr. Hall here.
Mission
Our mission is to serve as a resource for the world’s regulators, foster international collaboration and cooperation, and promote the drafting of biologic policy that is science-based and medically appropriate.
What’s Next for CBPE?
Over the coming year (2016), CBPE will be focused on sharing the results of this analysis with regulators and other interested parties around the world, and working together with them to address gaps in biosimilar policy.
The existing analysis will be updated to include additional countries, eg Australia, and adjustments will be made as appropriate as updates to existing policies are finalized.
An additional analysis will begin evaluating just how well biosimilar policies are implemented and enforced around the world.
The organization will continue to grow as we expand our Global Steering Committee. If you have experience with biologics and biosimilar policy and are interested in becoming involved with CBPE, please sign up and we will be in touch.
Frequently Asked Questions
What does CBPE do?
The Center for Biologics Policy Evaluation is an organization whose mission is to serve as a resource for the world’s regulators, foster international collaboration and cooperation, and promote the drafting of biologic policy that is science-based and medically appropriate. CBPE conducted an analysis to evaluate biosimilar guidelines from 12 countries around the world, to determine whether the standard of evidence required for approval is sufficient to ensure public health.
In the coming months, CBPE will be focused on sharing the results of this analysis with regulators and other interested parties around the world, and working together with them to address gaps in biosimilar policy. We will also be expanding and updating our analysis.
How is CBPE funded?
CBPE is a 501c3 organization. Initial funding was provided by Amgen Inc. in the form of an unrestricted grant.
How was this analysis done?
Each country or region was evaluated on 28 aspects of biosimilars policy, and rated on a scale of 1-5 (in 0.5 level increments) as compared with the WHO guidelines as follows:
1-2 minimally compliant with WHO regulations
3-4 partially compliant with WHO regulations
4 fully compliant with WHO regulations
5 exceeds the standards set by WHO
The scores across these 28 categories was averaged to give an overall score out of 5. Find your country’s score here.
Why was this analysis done?
The guidelines and standards for evaluating biosimilar medicines vary in different regions and countries around the world. CBPE conducted an analysis to evaluate biosimilar guidelines from 12 countries around the world, to determine whether the standard of evidence required for approval is sufficient to ensure public health.
Who did this analysis?
This analysis was performed by a former employee of the US Department of Health and Human Services, with over 20 years of policy experience.
How do I get involved with CBPE?