The ability, or inability, to chemically characterize a product should determine requirements for approval of a follow-on
NBCD. According to the FDA's 2012 Biosimilar Guidelines, the extent of clinical trials will depend on a number of factors
including the nature and complexity of the innovative product, the degree of understanding surrounding the mechanism of action
(MOA) for the follow-on product, the extent to which pharmacokinetic and pharmacodynamic testing can predict clinical outcomes,
the availability of appropriate endpoints and biomarkers, and the extent of clinical experience with the innovative and follow-on
product. Additionally, the importance of understanding the MOA and active portions of follow-on NBCDs cannot be overemphasized.
Without this available information, the characterization process of these products is suspect.
Globally, regulatory authorities have maintained that the clinically active portions of a pharmaceutical product must be defined
in order to demonstrate sameness for a follow on product. Without this essential component to the characterization of NBCDs,
regulatory authorities cannot definitively know whether the follow-on product is equivalent, or even similar, to the reference
drug. The issue of pharmaceutical equivalence/sameness is significant as it determines how much previous work can be relied
upon for the approval of new medications. ANVISA must determine the level of necessary data on a case-by-case basis to ensure
products available on the market possess adequate non-clinical and/or clinical data to ascertain sufficient safety and efficacy
ANVISA has made great strides in defining a regulatory pathway for biosimilars in order to bring these complex therapies to
market. With continued advancements in science, more complex therapies will continue to be brought to market. Oftentimes,
these complex therapies are able to provide benefits for patients that were previously unachievable. As the agency continues
to further define strategy for biosimilars, distinct guidelines should be developed surrounding NBCDs to ensure that all complex
products are safely regulated for patients.
J. Michael Nicholas, PhD is Senior Director, Life Cycle Initiatives at Teva Pharmaceuticals. He can be reached at firstname.lastname@example.org