FDA Releases Biosimilars Action Plan

https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM613761.pdf?utm_campaign=SBIA%3A%20FDA%20Releases%20Biosimilars%20Action%20Plan&utm_medium=email&utm_source=Eloqua

Today, FDA released the Biosimilars Action Plan (BAP) to provide information about the key actions the agency is taking to encourage innovation and competition among biologics and the development of biosimilars. 

The BAP is focused on four key areas: 

1. improving the efficiency of the biosimilar and interchangeable product development and approval process; 
2. maximizing scientific and regulatory clarity for the biosimilar product development community; 
3. developing effective communications to improve understanding of biosimilars among patients, clinicians, and payors; and 
4. supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay competition.

The agency is taking steps to more efficiently manage our review and licensure pathways to facilitate biosimilar competition. We are modernizing our policies that govern the development of biosimilars to make it more efficient. We are also educating clinicians, payors and patients about biosimilar products and the rigorous evaluation they must go through. And, we are modernizing regulatory policies to accommodate new scientific tools that can better enable comparison between biosimilars and reference products that may reduce the need for clinical studies.  These actions will help create a more competitive market today, while creating greater incentives for sponsors to make the investments required to support future products that deliver greater benefits to patients and public health after statutory exclusivities have expired.  

The BAP builds on the agency’s progress in implementing the approval pathway for biosimilar and interchangeable products. The marketplace for biosimilar and interchangeable products will continue to evolve. Therefore, the FDA considers this BAP to be dynamic. The agency will continue to identify activities that can be added to this program to advance regulatory science and better inform regulatory decision making to successfully address new issues and challenges. 

The FDA is committed to transparent, science-based regulation of biosimilar and interchangeable products that maintains the dynamic balance between innovation and timely access, as Congress intended. For more information, read Commissioner Gottlieb’s remarks “Dynamic Regulation: Key to Maintaining Balance Between Biosimilars Innovation and Competition” given today at the Brookings Institution about the BAP.