The guidance , entitled ‘Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product,’ is intended to aid biosimilar makers with the design and use of clinical pharmacology studies to support a decision that a proposed therapeutic biological product is biosimilar to its reference product.
According to the US Food and Drug Administration (FDA) guidelines, clinical pharmacology studies play a critical role in the development of biosimilar products and such studies are “part of a stepwise process for demonstrating biosimilarity between a proposed biosimilar product and the reference product.
“These studies may support a demonstration that there are no clinically meaningful differences between the products… [and] may address residual uncertainties that remain after the analytical evaluation, may add to the totality of the evidence supporting a demonstration of biosimilarity, and may also support a selective and targeted approach to the design of any recommended subsequent clinical studies to support a demonstration of biosimilarity.”
The final guidance comes almost 20 months after a heavily criticised draft version was published.
At the time industry groups BIO and PhRMA, as well as biopharma firm Genentech, took issue with the FDA’s four possible outcomes and the terminology for the analytical comparison of a proposed biosimilar product with its reference product, which includes the categories: (1) not similar; (2) similar; (3) highly similar; and (4) highly similar with fingerprint-like similarity, as well as
The final guidance has rephrased these to: (1) Insufficient analytical similarity; (2) Analytical similarity with residual uncertainty; (3) Tentative analytical similarity; and (4) Fingerprint-like analytical similarity.
While the guidance is one in a series developed to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), industry is still awaiting guidance on the interchangeability of biosimilar products despite the FDA saying it would be published in 2016 .