Truxima (CT-P10) a biosimilar to Rituxan (rituximab), has been unanimously recommended for approval by the U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee for the treatment of three non-Hodgkin’s lymphoma (NHL) indications, Celltrion and Teva announced.
The recommendation is for patients with a low grade of follicular B-cell NHL whose cancer cells produce the CD20 factor and have failed prior treatments, and for CD20-positive B-cell NHL patients who achieved at least stable disease after receiving a chemotherapy regimen containing cyclophosphamide, vincristine, and prednisone.
The third indication includes patients with CD20-positive follicular lymphoma who either had not received any prior therapies — in combination with chemotherapy — or who had responded to prior Rituxan-based chemotherapy — for which Truxima would be given as a maintenance treatment.
Recommendations from the FDA’s committees are not binding, but the agency usually follows their advice when making its decisions.
“We welcome the Oncologic Drugs Advisory Committee’s recommendation. If approved by the FDA, CT-P10, a proposed biosimilar to Rituxan, will be the first rituximab biosimilar to be approved in the United States for the three proposed indications,” Woosung Kee, CEO of Celltrion, said in a press release. “The development of biosimilars is of great importance in the field of oncology, and has the potential to increase accessibility to therapies 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.
Because biological medicines are grown in cells and not made through chemical reactions, they may show some differences even if the design is the same. As a result, the FDA requires extensive data to determine if the biosimilar works the same as its original medicine — in terms of how effectively the therapy treats the disease, as well as its safety and how it behaves when it enters the body.
Truxima is a biosimilar of Rituxan, an antibody that binds the CD20 protein on immune and cancer B-cells and destroys them.
The recommendation is based on two randomized, double-blind Phase 3 clinical trials that compared Truxima with Rituxan: CT-P10 3.3 (NCT02162771) and CT-P10 3.4 (NCT02260804). The trials showed no differences in the incidence of adverse events and similar effectiveness between both medicines.
Rituxan is currently approved for several indications, including lymphoma, leukemia, rheumatoid arthritis, ANCA-associated vasculitis, and pemphigus vulgaris — a rare chronic blistering skin disease.
Truxima is already approved in 47 countries across the globe for the same indications as Rituxan, and was the first monoclonal antibody biosimilar to be approved in Europe for cancer treatment. It is jointly commercialized by Celltrion and Teva as part of a 2016 partnership.
“If approved, Teva is well positioned to successfully commercialize CT-P10, given our unique portfolio of branded and generic medications, as well as patient support experience,” said Brendan O’Grady, executive vice president and head of North America Commercial at Teva. “We are encouraged by the outcome of today’s meeting, which emphasizes the growing importance of biosimilars and the potential value to be introduced into our health systems.”