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Final Biosimilars Pathway Must Make Patient Safety and Incentives For Continued Innovation Top Priorities, Says BIO

WASHINGTON, D.C. (Wednesday, November 03, 2010) - The following statement was issued by Sara Radcliffe, executive vice president for Health at the Biotechnology Industry Organization (BIO), who is scheduled to participate today in the U.S. Food and Drug Administration’s (FDA) Public Hearing on the Approval Pathway for Biosimilar and Interchangeable Biological Products:

“BIO supported the passage of legislation to enable the FDA to approve biosimilars.  As the FDA considers how best to implement the pathway for approving biosimilars, we call on the Agency to make patient safety the top priority while preserving incentives for future biotech innovation.  There can be no shortcuts to safety on the pathway to biosimilars.

“In our comments at the FDA’s Public Hearing, BIO will underscore the importance of analytical, non-clinical, and clinical studies, such as immunogenicity testing, to protecting patient safety.  While the scope of clinical studies required should depend on several factors, including the findings and limitations of analytical and nonclinical studies, clinical studies will always be necessary and should stringently compare the innovator product and the biosimilar. 

“To be deemed ‘interchangeable’ by FDA under the law, biosimilars must be, ‘expected to produce the same clinical result as the reference product in any given patient.’  BIO will testify that to protect patient safety, there should be no divergence in safety or efficacy profiles when ’interchangeable’ products are substituted or alternated by any individual in any relevant patient population.  More, any decision to substitute or alternate a biosimilar for an innovator biologic must involve patients and their physicians.

“We strongly believe the final regulatory structure for biosimilars must include mechanisms to allow for robust post-marketing data collection and evaluation along with unique trade and nonproprietary names, so that safety issues can be recognized quickly and patient risk can be limited. 

“Furthermore, it is critical that the pathway preserve incentives for innovation to help realize the potential of biologics to address unmet medical needs, including treating diseases such as cancer, HIV/AIDS, Alzheimer’s and multiple sclerosis.  To that end, we urge the FDA to maintain the careful balance established in the Biologics Price Competition and Innovation Act which increases competition with the introduction of biosimilars while providing the incentives necessary to promote future drug development with a 12-year period of data exclusivity for innovator biologics.  These incentives also include the provision in the law which recognizes that an innovative biologic that is modified structurally, resulting in a change to safety, purity, or potency, is a distinct product that obtains its own 12-year period of exclusivity.

“In addition, the final pathway must protect the rights and confidential information of the innovator.  This includes establishing proper procedures that provide adequate notice of and access to the content of biosimilars applications and provide that the FDA rely only on publicly-available information about the reference product as the Agency reviews biosimilar applications. 

“We appreciate the opportunity to share our views with the Agency.  Implementing the right pathway for approval of biosimilars is essential to expanding access to biologics, which are among the most powerful cutting-edge medicines being produced today.  We look forward to continuing to work with the FDA on implementing this important statute.”

The power point presentation which will accompany Radcliffe’s testimony is available here.

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