Celltrion, Teva: FDA OKs non-Hodgkins lymphoma biosimilar

Celltrion, Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved TRUXIMA^® ituximab-abbs), a monoclonal antibody (mAb) biosimilar to RITUXAN^®1
(rituximab) 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) as a single agent.
• 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, as single-agent maintenance therapy.
• Non-progressing (including stable disease), low-grade, CD20-positive,
  B-cell NHL as a single agent after first-line cyclophosphamide,
  vincristine, and prednisone (CVP) chemotherapy.

“The approval of TRUXIMA is a significant milestone for Celltrion and,
more notably, for the patients who need access to this important
medication,” said Woosung Kee, Chief Executive Officer of Celltrion.
“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.”

https://www.benzinga.com/pressreleases/18/11/b12767389/celltrion-and-teva-announce-fda-approval-of-truxima-rituximab-abbs-a-b

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