The Food and Drug Administration has approved the first biosimilar version of a drug commonly used to treat the most widespread forms of lymphoma.
The agency said Wednesday that it had approved Truxima (rituximab-abbs), a biosimilar version of Roche and Genentech’s Rituxan (rituximab), for B-cell non-Hodgkin’s lymphoma, or B-NHL. South Korean drugmaker Celltrion and Israel-based Teva Pharmaceutical Industries have a partnership to commercialize the drug in the US and Canada.
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The biosimilar is approved as a single agent in patients with relapsed or refractory low-grade or follicular B-NHL; combined with first-line chemotherapy in patients with first-line follicular lymphoma and also as a single-agent maintenance therapy after they achieve remission; and in low-grade B-NHL that is not progressing combined with the chemotherapy drugs cyclophosphamide, vincristine and the steroid prednisone, a combination known as R-CVP. The approval follows an FDA Oncologic Drugs Advisory Committee vote last month to recommend the agency approve the drug for the three indications, which had been proposed for the label.
The biosimilar, like Rituxan, targets the antigen CD20 on the surface of cancer cells, and a patient’s disease must express the antigen for either product to work.
However, the label that the FDA granted Truxima is much more restricted than the one the European Medicines Agency gave when it approved the product last February. In addition to the three aforementioned indications, Rituxan is also approved to treat first-line diffuse large B-cell lymphoma – or DLBCL, a high-grade form of B-NHL – as well as first-line chronic lymphocytic leukemia, or CLL, and the autoimmune diseases rheumatoid arthritis, granulomatosis with polyangiitis and moderate to severe pemphigus vulgaris. Truxima’s European label also includes all of those.
Rituxan has long been a mainstay of treatment for the various histological subtypes of B-NHL since its approval in 1997. In addition to R-CVP, in B-NHL treatment it is combined with those drugs plus doxorubicin, a combination known as R-CHOP. In CLL, it is combined with cyclophosphamide and fludarabine.
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The FDA initially rejected Celltrion’s regulatory approval application for Truxima, also known by its development name, CT-P10. The company had submitted its biologics license application in April of this year, but the FDA issued a complete response letter – a notice of rejection, also called a CRL – in relation to a warning letter it had issued to the company in January about concerns over manufacturing at the company’s plant in the South Korean city of Incheon. The company resubmitted its application in May.
Photo: Dmitrii_Guzhanin
