ODAC Hearing Shows the Mood on Biosimilars Is Changing, Oncologist Says

Earlier this week, the FDA’s Oncologic Drug Advisory Committee (ODAC) held an open public hearing to discuss the Biologics License Application for CT-P10, Celltrion’s proposed rituximab biosimilar. The committee voted unanimously to recommend approval of the dug based on evidence from 2 confirmatory safety and efficacy trials.

Among stakeholders who testified in support of approving CT-P10 was Kashyap Patel, MD, a medical oncologist at Carolina Blood and Cancer Care. Patel told The Center for Biosimilars^® in an interview following the hearing that much has changed since last year’s ODAC hearing on the anticancer biosimilars trastuzumab and bevacizumab.

In the July 2017 proceedings, some stakeholders highlighted concerns about postapproval pharmacovigilance efforts for biosimilars, and about clinical trial design for the products. However, in this week’s hearing, said Patel, “Clearly, the mood has changed to be a lot more favorable for the biosimilars.”

Patel described the hearing as “upbeat” about the prospective licensure of the drug, and noted that drug developer Celltrion had done a thorough job of addressing the FDA’s concerns with its data, and very little discussion centered around concerns about the safety or immunogenicity of the product. The FDA, too, said Patel, did well to thoroughly assess the drug’s data and to clearly communicate the meaning of the totality of the evidence supporting approval.

While Celltrion indicated during the hearing that it was only seeking 3 indications for its biosimilar product as a result of the patents covering the brand-name Rituxan, Patel indicated that he would not be surprised to see physicians adopt the biosimilar for other indications on the basis of extrapolation. He noted that, in oncology, approximately one-third of product use is based on either extrapolation or a compendium listing, and it would not be unlikely that, with growing concerns about cost and growing acceptance of biosimilars, CT-P10 could find its way to patients who need treatment for indications outside of those sought by Celltrion.

In looking to his own practice, Patel is enthusiastic about the potential for the biosimilar to result in increased access and affordability of anticancer treatment for his patients. In his rural practice setting, approximately 20% of Patel’s patients are underinsured, and some face the choice between putting food on the table and paying for their care. “This will not solve it all,” Patel said, but a cheaper anticancer therapeutic would help to ease these patients’ financial burdens related to their out-of-pocket costs.

Patel also sees clear benefits for his practice. As an Oncology Care Model (OCM) participant, his practice has already seen substantial cost savings from using biosimilar filgrastim instead of its reference in treating and preventing febrile neutropenia associated with myelosuppressive chemotherapy. In fact, 7% of the practice’s OCM savings came from biosimilar use alone. Using biosimilar rituximab, he indicated, could help to produce even further savings.