NeuClone's Proposed Trastuzumab Biosimilar Met Primary, Secondary End Points in Phase 1 Trial

Australia-based drug maker NeuClone announced this week that its proposed biosimilar trastuzumab, referencing Herceptin, met all primary and secondary end points in a phase 1 clinical study that compared the product with its US- and EU-licensed reference.

The product, being developed together with the Serum Institute of India, will prospectively be sold under the name NeuCeptin if it eventually gains regulatory approval.

The trial was a randomized, double-blind, single-dose, 3-arm study that evaluated the pharmacokinetics (PK) and safety of the biosimilar versus the reference in 100 healthy volunteers in Australia. The participants received either the biosimilar, the US reference, or the EU reference as a single intravenous infusion.

The PK end points included area under the concentration-time curve (AUC) from first to last timepoint measured, AUC from time zero extrapolated to infinity, and maximum serum concentration. The 90% CIs of each end point fell within the prespecified bioequivalence margin of 80% to 125% for all of the pairwise comparisons, said the company.

“Positive results from the NeuCeptin trial reflect our dedication to provide high-quality, affordable biologics to a greater number of patients,” said Noelle Sunstrom, PhD, chief executive officer and founder of NeuClone, in a statement announcing the results. “Pharmacokinetics are pivotal to the demonstration of biosimilarity and these successful results greatly de-risk this particular program and also validate NeuClone and Serum Institute’s development approach to be replicated for many biosimilars in our pipeline.”

NeuClone did not specify whether it intends to move to a phase 3 clinical trial for the biosimilar. In fact, in its statement on the phase 1 results, the company noted that phase 3 trials are not required to achieve regulatory clearance, and highlighted the fact that no biosimilars that have been found to be highly similar in analytical and PK studies have failed to gain approval in the United States, European Union, Canada, or Australia.

Phase 3 clinical trials for biosimilars have come under fire from critics who argue that these may no longer provide the most meaningful information on the equivalence of biosimilars and their reference products, and may in fact be unethical. Instead of undertaking superfluous and expensive studies that delay biosimilar approval and drive up costs, say some experts, analytical studies, including PK studies, can serve to ensure that any differences between a biosimilar and its reference have no adverse impacts.