ODAC Unanimously Recommends Celltrion's Biosimilar Rituximab for FDA Approval

The Oncologic Drug Advisory Committee (ODAC) held an open public hearing this morning at the FDA campus in Silver Spring, Maryland, to discuss the Biologics License Application (BLA) for a proposed rituximab biosimilar, CT-P10, developed by Celltrion and referencing Genentech’s Rituxan.

In 2016, Celltrion and Teva Pharmaceuticals entered into a commercialization agreement for 2 potential biosimilars. As such, Teva representatives were also on hand today to present data and field questions about CT-P10 together with Celltrion.

The committee heard data presented from various speakers, including advisory officials for the FDA who analyzed the data prior to the presentation. According to the FDA, although there were minor differences in clinically inactive compounds, the totality of the evidence suggested that the proposed biosimilar is highly similar to the reference product with no clinically meaningful differences.

However, FDA presenters did note that in 1 study to determine clinical efficacy and safety, there was a higher incidence of neutropenia in the CT-P10 arm than in the reference Rituxan arm. This was potentially explained by 2 factors: first, the study sample size was small, with only 70 patients (of whom a total of 28 experienced neutropenia) enrolled in each arm. Second, more patients in the CT-P10 arm had bone marrow involvement at the time of enrollment (n = 45) than in the reference arm (n = 33).

To address these concerns, the product sponsor conducted a second trial that enrolled 258 patients, 130 to the CT-P10 arm and 128 to the reference product arm. In this study, there were no differences in the incidence of neutropenia across study arms. In considering the totality of the evidence and data from both studies, the FDA concluded that the differences in clinical safety are “unlikely to be clinically meaningful,” and supported the assertion that there are no meaningful differences between the products.

Speaking in support of the recommendation of CT-P10 for approval during the public hearing portion of the meeting were The Center for Biosimilars^® advisory board members Sonia Oskouei, PharmD, Kashyap Patel, MD, and Joseph Fuhr, PhD.

Oskouei, Patel, and Fuhr echoed one another in emphasizing that ODAC should consider the totality scientific evidence at its basis, as it supports the licensure of the biosimilar, and, if approved, increased biosimilar competition has the potential to decrease the price of expensive biologics, and therefore increase patient access to these medications.

In a vote on whether the totality of the evidence supported the licensure of CT-P10 as a biosimilar to Rituxan, all 16 committee members voted yes, for reasons some enumerated as “overwhelming biosimilarity and clinical trial evidence” that “really sealed the deal.”

Celltrion is seeking indications for the treatment of non-Hodgkin lymphoma (NHL) only, and is not seeking an indication for the treatment of inflammatory disease. When ODAC members asked about the reasoning behind only seeking an indication in NHL, a Celltrion representative stated that “We are only seeking approval in 3 [NHL] indications given the patent and exclusivity landscape at this time.”