Fierce Biotech reports that a leading group of FDA regulators have published in the NEJM the "agency's thinking" on the proposed pathway to gain approval for a biosimilar. It looks to be complex and customized to the product in question. Anyone looking for a short, simple, straightforward and inexpensive abbreviated pathway need not apply.
The regulators say that there will be no "one size fits all" systematic assessment for biosimilars. Instead developers will need to integrate various types of evidence "since it seems possible to exceed a current state-of-the-art analytic characterization by evaluating more attributes and combinations of attributes at greater sensitivities with multiple complementary methods." That sentence is a mouthful and certainly implies to me a high level of regulatory rigor.
The FDA warns it will need to create a new "paradigm" for its initial discussions with biosimilar developers, with a more extensive product review to detail the additional data needed for a biosimilar approval. Rules on interchangeability, which would allow doctors to switch a branded biologic for a biosimilar, are still in the works.
Bottom line, the FDA is setting clinical demands that will raise effort and expenses to meet approval requirements. This will undoubtedly limit the field to larger players who will have the financial wherewithal and resources to compete.
Posted by Bruce Lehr Aug 4th 2011.