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FDA to Release Guidance Document on Approval Pathway for Biosimilars
Originally published in the November-December 2011 NABP Newsletter
Food and Drug Administration (FDA) continues the process of developing an approval pathway for biosimilars, the generic equivalent of biologic drug products. The agency plans to release a draft guidance for applicants initiating biosimilar development programs by the end of 2011. Once an approval process is implemented, biosimilars may potentially increase the availability of biologic drug therapies to more patients. Further, the Biologics Price Competition and Innovation (BPCI) Act of 2009 allows for drug makers to meet a “higher standard of similarity to a reference product –‘interchangeability.’” For drugs deemed by FDA to be interchangeable, pharmacists will be allowed to make “substitutions between biologics without the prescriber’s intervention.” To meet this higher standard, FDA explains, it must be demonstrated that the product “can be expected to produce the same clinical result in any given patient and that the risk associated with alternating or switching between the two products is not greater than that involved in continuing to use the reference product.” FDA will develop the regulatory standards for use of interchangeable biosimilars and will also develop standards to ensure that products not deemed interchangeable “are not inadvertently substituted for a reference product without the prescriber’s consent.”
In an article published in The New England Journal of Medicine, FDA scientists from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) detail the challenges in developing a biosimilar approval pathway and provide information about the scientific approaches being considered.
The authors note some of the challenges in balancing science and the regulatory framework, and point to the direction FDA is taking as it develops an approval pathway. FDA believes that a “one size fits all” approach is unlikely.
FDA explains that currently a “totality of evidence” approach along with FDA’s experience in identifying fingerprint-like patterns “will be essential in designing a U.S. biosimilars policy that encourages development of biosimilars, emphasizing the use of innovative technologies.” Totality of evidence involves FDA scientists integrating “various types of information to provide an overall assessment that a biologic is biosimilar to an approved reference product.” FDA has begun to identify the challenges with the totality of evidence approach and considered how to work with manufacturers in the pre-approval process. FDA will use a familiar risk-based approach in evaluating biosimilars, and the process will include product-specific safety monitoring.
In developing the forthcoming draft guidance for biosimilar applicants, FDA continued to assess information received at its November 2010 public meeting, and on July 29, 2011, FDA held a public stakeholder meeting to discuss recommendations for the developing biosimilars user fee program. At that time FDA provided an update on the agency’s implementation of the BPCI Act and described the roles of the three committees that have been established to ensure consistency in FDA’s regulatory approach and guidance to applicants regarding development programs for proposed biosimilar biological products. The committees include:
the CDER Biosimilar Review Committee,
the CBER Biosimilar Review Committee, and
the CDER/CBER Biosimilar Implementation Committee (BIC).
FDA stated that “the CDER/CBER BIC is the forum to discuss policy issues, while the review committees focus on product-specific and scientific issues related to applicants’ requests for advice concerning proposed biosimilar development programs.”
