The FDA's Oncologic Drugs Advisory Committee (ODAC) briefing documents state that the totality of the evidence suggests that the proposed biosimilar is highly similar to its US-licensed reference, despite minor differences in clinically inactive compounds.
Ahead of the Oncologic Drugs Advisory Committee (ODAC) that will convene on Wednesday, October 10, 2018, the FDA has released briefing documents containing much of the data, (though some redacted) of the Biologics License Application (BLA) for CT-P10, a proposed rituximab biosimilar referenced on Genentech’s Rituxan and developed by Celltrion.
The FDA’s documents state that the totality of the evidence suggests that the proposed biosimilar is highly similar to its US-licensed reference, despite minor differences in clinically inactive compounds.
The analytical similarity data package included in the BLA that was submitted to the FDA consisted of 3 comparisons: CT-P10 to Rituxan; CT-P10 to the European Union's version of Rituxan, licensed as MabThera; and EU-licensed MabThera to the US-licensed Rituxan. The FDA noted that “the analytical methods were appropriately validated or qualified and are suitable for their intended use.”
During the meeting, the committee will vote on whether to recommend approval of CT-P10 as a biosimilar product for the treatment of adult patients with non-Hodgkin lymphoma. Notably, Celltrion is not seeking approval for the indication of rheumatoid arthritis (RA), despite the fact that the FDA will be considering immunogenicity data in which CT-P10 and Rituxan were compared in a multiple-dose parallel-arm study in patients with RA. The data indicate that there was no increase in immunogenicity risks for CT-P10 as compared with Rituxan in this population, and no increased safety risk with a single transition from US-licensed Rituxan to CT-P10.
While Celltrion’s application was originally submitted in April 2017, the FDA issued a Complete Response Letter (CRL) in February 2018 regarding “clinical, product quality, and facility deficiencies.” After resolving the concerns outlined in the CRL, Celltrion resubmitted the BLA in May. If approved, CT-P10 would become the United States’ first biosimilar rituximab.
The ODAC is set to convene at 8:00 AM, Eastern Standard Time.