Over the past ten years, FDA has made advances, learned from their experiences, and continues to demonstrate flexibility in biosimilar development while upholding regulatory and scientific standards. For example, PD and biomarkers eliminated the need for a CCS for some less complex biosimilars. Likewise, FDA recently
declared that if the comparative analytical assessment for a proposed biosimilar or interchangeable insulin supported a demonstration that the products were highly similar, ”a comparative clinical immunogenicity study generally would be unnecessary to support a demonstration of biosimilarity or interchangeability.”
It may be many more years before technological advances, structure-function-clinical performance understanding, and global experience with biosimilars completely align to eliminate the necessity for CCS data. Until then, revisiting the current role of the CCS in light of knowledge and data gathered over the first ten years of US biosimilar experience should be considered in order to further advance the goals of expanded market access to critical biological treatments in the next decade.
References available upon request.