Earlier this month, the U.S. Food and Drug Administration recently published its long-awaited guidance documents on Biosimilars/Biosimilarity (see "FDA Publishes Draft Guidelines for Biosimilar Product Development" and "More on FDA Draft Guidelines for "Follow-on" Biologic Drug Approval Pathway"). Some of the first public statements made by the FDA regarding these newly-published biosimilar guidance documents were made in a February 15 presentation by Dr. Rachel E. Sherman, Associate Director for Medical Policy at the Center for Drug Evaluation and Research. Dr. Sherman moved through the guidance documents quickly, without exploring any particular issues in detail, but there were several notable messages in her presentation that expand beyond the text of the statute and the guidance documents.
Dr. Sherman (at left) opened by noting that the presentation represented the first opportunity for the FDA to interact with the audience targeted by the guidance documents. The FDA has continually emphasized the guidances' wide target audience, comprising consumers (patients), patient advocacy groups, health care providers, as well as those in the pharmaceutical industry. The FDA's effort to draft the guidelines so as to be understandable to the average consumer may partially explain the minimal specific requirements throughout the guidance documents. The presentation continued with an overview of the Biologics Price Competition and Innovation Act (BPCIA) and its effects on the approval of biologics under the current statutory framework (PHSA and FFDCA). The BPCIA will consolidate the approval of all biologics, as the FDA strongly disapproves the current two-option framework, allowing certain biologics to be approved under either the PHSA or the FFDCA. The transition to a single approval pathway under the BPCIA is expected to be completed by 2020.
The FDA next responded to the criticism that the abbreviated approval pathway does not promote innovation. The FDA considers the biosimilarity approval pathway to be innovative because each analytical study required of biosimilar applicants will advance the field of knowledge regarding the molecule of interest. For example, a biosimilar applicant may have to characterize the function of particular amino acids in binding domains of its biosimilar product, thus providing date to others in the field as to the homology requirements of its biologic. The FDA would then make a determination of biosimilarity, and consider whether the FDA would require additional testing/studies to support a finding of biosimilarity. This determination is presented using an entertaining analogy.
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