Lilly and Innovent's Biosimilar Rituximab to Be Reviewed by China's Regulators

Eli Lilly and Company, together with partner Innovent Biologics, announced today that China’s National Medical Products Administration will review its application for IBI301, a proposed rituximab biosimilar referencing MabThera and Rituxan.

According to the partnership, the biosimilar has the opportunity to increase access for Chinese patients; despite a high unmet demand for effective cancer treatments, use of rituximab remains relatively low due to its high cost.

Li Wang, MD, PhD, senior vice president of Lilly China and head of Lilly China drug development and medical affairs, said of the submission in a statement, "The NDA of IBI301 represents another millstone of strategic cooperation between Lilly and Innovent. We hope that IBI301 can be approved soon in order to offer an affordable treatment option for lymphoma patients in China."

Last month, the partnership announced that 2 studies of the biosimilar had met their primary end points. The first, a single-dose study, assessed the pharmacokinetics, safety, tolerability, and immunogenicity of the biosimilar versus the reference drug in 181 patients with CD20-positive B-cell lymphoma. The drug makers reported that the study met its primary end point, area under the concentration—time curve from time zero to infinity, over a time frame of 91 days.

The second study, a phase 3 trial in 420 patients with diffuse large B-cell lymphoma who received either the biosimilar or the reference drug in combination with standard chemotherapy for 6 cycles as first-line treatment for newly diagnosed disease, met its primary end point of overall response rate over a time frame of 18 weeks.

If approved, Lilly and Innovent’s rituximab will join 1 other approved biosimilar rituximab product in the Chinese marketplace; in February 2019, China approved Henlius’ HLX01. Approval of this rituximab product was a milestone for the Chinese market, as it was not only the first rituximab biosimilar to be approved in the market, but also the first biosimilar to be cleared under the country’s biosimilar approval pathway.