The U.S. Food and Drug Administration has approved Truxima (rituximab-abbs), a biosimilar to Rituxan (rituximab), for three CD20-positive non-Hodgkin’s lymphoma indications, Celltrion and Teva announced.
The decision comes less than two months after the FDA’s Oncologic Drugs Advisory Committee unanimously recommended Truxima’s approval, and makes it the first biosimilar approved in the U.S. for non-Hodgkin’s lymphoma.
The approvals are for patients with low-grade or follicular lymphoma who failed at least one prior treatment and for patients with low-grade lymphoma who achieved at least stable disease after first-line chemotherapy — cyclophosphamide, vincristine, and prednisone.
The third indication is for follicular lymphoma patients who have not received any prior treatment, to whom it is given in combination with chemotherapy, and for those who responded partially or totally to a Rituxan-based chemotherapy, to whom Truxima is given alone as a maintenance therapy.
“The approval of Truxima is a significant milestone for Celltrion and, more notably, for the patients who need access to this important medication,” Woosung Kee, CEO of Celltrion, said in a press release. “Truxima is the very first rituximab biosimilar to be approved in the United States for three non-Hodgkin’s lymphoma indications and may help provide greater accessibility for patients.”
Biosimilars are biological medical products that are nearly identical to an original product, but manufactured by a different company after the original product’s patent expires. They usually are sold at significantly lower prices.
Unlike chemical compounds, which are made through chemical reactions, biological medicines are grown in cells and may show some differences from similarly designed products.
The FDA and other regulatory agencies require extensive data showing that a biosimilar has a similar behavior to the original medicine, not only in terms of effectiveness and safety, but also regarding the compound’s behavior — absorption, distribution, metabolism, and excretion — once inside the body.
“As part of the FDA’s Biosimilars Action Plan we’re advancing new policies to make the development of biosimilars more efficient and to enable more opportunities for biosimilar manufacturers to make these products commercially successful and competitive,” Scott Gottlieb, MD, FDA commissioner, said in an FDA press release. “Our goal is to promote competition that can expand patient access to important medicines.”
“We’ll continue to make sure biosimilar medications are evaluated efficiently through a process that makes certain that these new medicines meet the FDA’s rigorous standards for approval,” he added.
Truxima, like its original medicine Rituxan, is an antibody that targets the CD20 molecule found in healthy B-cells and lymphoma cells. By inhibiting the excessive growth and spread of B-cells, the treatment improves lymphoma symptoms.
The approval is based on extensive animal and human data demonstrating that Truxima is a biosimilar to Rituxan. Among the data, the FDA committee reviewed results from two randomized Phase 3 trials — CT-P10 3.3 (NCT02162771) and CT-P10 3.4 (NCT02260804) — showing that Truxima and Rituxan have a similar effectiveness and incidence of adverse events in all three indications.
The most common adverse events of Truxima were infusion reactions, fever, low lymphocyte counts, chills, infection, and weakness. Like Rituxan, Truxima’s label includes a Boxed Warning on the increased risks of fatal infusion reactions, severe skin and mouth reactions, reactivation of Hepatitis B virus with serious liver problems, and brain infection.
Truxima is already approved in 47 countries worldwide for the same indications as Rituxan, including in Europe. It is jointly commercialized by Celltrion and Teva as part of a 2016 partnership.
“This is an exciting time to be involved in the biosimilars space and we look forward to bringing the product to market,” said Brendan O’Grady, executive vice president and head of North America Commercial at Teva. “There is a stronger focus than ever, particularly within oncology, on bringing greater value to the healthcare system through biosimilars increasing the number of treatment options.”