PharmaNet Offers Guidance on Regulatory Pathway for Biosimilars Development
Product News Dec 21, 2010
The two day public hearing aimed to obtain input from interested stakeholders on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
PharmaNet recently attended the two day FDA hearing. While the FDA hearing highlighted the diverse approaches and opinions presented by different industry participants, PharmaNet in-house experts, including some former senior level officials from the FDA, are available to offer insight into industry and regulatory perspectives. As an industry leading CRO with experience in clinical development and regulatory issues of branded innovator biologics and generic drugs, the Company is available to provide advice to industry members developing biosimilars.
“At PharmaNet, we believe that patient safety (immunogenicity) will emerge as a key issue and that carefully designed clinical trials will be crucial in this process. It is extremely important that these issues are openly and frankly discussed, commented Jeffrey Freitag, M.D., Senior Vice President. “This hearing was an excellent forum for the FDA to receive valuable input from a range of interested stakeholders. While the regulatory pathway is still to be determined, the opinions expressed should help the FDA develop guidance going forward.” PharmaNet provides large molecule bioanalytical services, including immunogenicity testing, for the development of biologics and biosimilars.
Biosimilars are new but not identical versions of biologic products that have reached patent expiration. In 2006, the European Medicines Agency (EMEA) became the first regulatory body to establish a pathway and provide guidance for biosimilar approval. With the passage of The Affordable Healthcare for Americans Act in March 2010, a regulatory pathway was established in the US allowing for implementation of the BPCI Act. The FDA Implementation of the BPCI Act establishes an abbreviated approval pathway for biological products that demonstrate to be “highly similar” or “interchangeable” with an already FDA-licensed biological product. An abbreviated approval pathway for biological products will present challenges given the scientific and technical complexities associated with the larger and often more complex structures of biological products and will create much debate and diverse opinions among stakeholders as demonstrated at the recent 2-day FDA hearing.
During the hearing, views were exchanged between the FDA, consumer advocates and major industry stakeholders including pharmaceutical innovator companies, biosimilar drug development companies, drug distribution entities, and clinical research organizations (CROs). While all parties generally agreed on the benefits of lower cost biologics, there seemed to be two differing positions on how to accomplish that. One position focused on the need to obtain sufficient pre-clinical and robust clinical data to ensure safety and efficacy, did not favor automatic interchangeablility, and was cautious about extrapolation to other indications without appropriate studies. The other position favored more emphasis on the demonstration of analytical similarity with less emphasis on conducting what might be unnecessary pre-clinical animal and clinical studies. This second position also favored interchangeability and extrapolation to other indications. Consumer groups were particularly concerned about safety and efficacy issues with overly aggressive abbreviated development programs. It also became apparent that innovative trial designs would likely be needed to allow for a reasonably sized clinical program to be accomplished. Finally, it was acknowledged that the biosimilar drug development/approval in Europe has been smooth and generally without problems; therefore, a question was raised as to why those approved biosimilars could not enter the US market with minimal additional development effort.