UPDATE : Thursday, August 13, 2020
Celltrion wins FDA nod for rituximab biosimilar
  • By Lee Han-soo
  • Published 2018.11.29 10:50
  • Updated 2018.11.29 14:56
  • comments 0

Celltrion said Thursday that the U.S. Food and Drug Administration has approved Truxima (Ingredient: rituximab-abbs), a monoclonal antibody (mAb) biosimilar to Rituxan (rituximab) for treating adult patients with non-Hodgkin’s lymphoma.

According to the company, The U.S. market for rituximab is about 5 trillion won ($4.4 billion), the largest market in the world by accounting for 56 percent of the global rituximab sales.

“As Truxima is the first rituximab biosimilar approved in the U.S., Celltrion will enter the world's largest Rituximab market as a first mover and enjoy significant market preemption,” the company said. Celltrion also expects to secure an overwhelming market position as in Europe, as it has been able to preempt the market in the U.S. without competitors due to its competitors' giving up on the U.S. market.

“The approval of Truxima is a significant milestone for Celltrion and, more notably, for the patients who need access to this important medication,” Celltrion CEO Kee Woo-sung said. “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.”

Teva, a multinational pharmaceutical that has marketing license for Truxima in North America, will sell the product in the U.S.

Brendan O’Grady, execute vice president and head of North America Commercial at Teva, said, “This is an exciting time to be involved in the biosimilars space, and we look forward to bringing the product to market. 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.”

The FDA has approved the drug for the treatment of adult patients in three indications -- relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non–Hodgkin’s lymphoma (NHL), previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy, and in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, and non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.

The U.S. agency said it approved Truxima based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic data, clinical immunogenicity data, and other clinical data that demonstrates Truxima is a biosimilar to Rituxan.

“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,” FDA Commissioner Scott Gottlieb said. “Our goal is to promote competition that can expand patient access to important medicines.”

Truxima approval is the third biosimilar approval in the past month, he added.


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