Clinical Pharmacology Studies // Drug Repurposing

Clinical Pharmacology Studies

Early-phase clinical

As previously reported here, in February 2012, FDA released three highly-anticipated guidances on biosimilars. Those of us interested in biosimilars have naturally been eagerly awaiting the next usual step in the process, the issuance of final guidances and perhaps the first approval of a biosimilar product under the 2010 BPCIA. Dashing these expectations, however, FDA has instead issued another draft guidance, one that expands upon some previously-covered topics but also repeats much of what was said in 2012. Forgive us for wondering whether the guidance moves us one step closer to approval of the first BPCIA biosimilar or moves the date further out into the future. Put another way, will the stepwise process FDA first unveiled in 2012 be a walk in the park for sponsors or an ultra-marathon?

On May 13, 2014, FDA released a draft guidance entitled Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product. It lays out an elaborate step-by-step process for demonstrating that the hoped-for biosimilar and the reference product are “highly similar” and pegs clinical pharmacology studies as a likely piece of the “totality of evidence” needed to meet the statutory standard of “no clinically meaningful differences … in terms of “safety, purity, and potency.”

Similar to what is laid out in the 2012 draft guidance, the step-by-step process is described as a risk-based approach under which FDA will consider the totality of the data submitted. Sponsors are encouraged to collect data in the following order: structural and functional characterization, nonclinical evaluations, human pharmacokinetic and pharmacodynamic studies, clinical immunogenicity studies, clinical safety studies and when necessary clinical effectiveness studies. The criterion for sponsors to use in determining whether the next step in this process is necessary is the amount of “residual uncertainty” that remains regarding similarity of the products.

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