FDA Approves Biosimilar Ruxience: Here's What You Need to Know


With the Food and Drug Administration’s approval of Ruxience, a biosimilar to Rituxan, patients with certain types of non-Hodgkin lymphoma and chronic lymphocytic leukemia may have improved access to a more affordable treatment option.

With the Food and Drug Administration’s (FDA) approval of Ruxience (rituximab-pvvr), a biosimilar to Rituxan (rituximab), patients with certain types of non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) may have improved access to a more affordable treatment option, according to Lee Greenberger, an expert with the Leukemia & Lymphoma Society (LLS).

“The use of rituximab has significantly improved treatment outcomes for patients with CLL and some of the most common (non-Hodgkin lymphomas). Since its approval in 1997, it has become a backbone of so-called R-CHOP therapy for the treatment of many B-cell (non-Hodgkin lymphomas) — approximately 80,000 new patients each year in the U.S. — which combines rituximab with cytotoxic chemotherapy,” said Greenberger, chief scientific officer of LLS. “The approval of a biosimilar for this treatment will provide a more affordable option for patients.”

What Are Biosimilars?

In the United States, this is the second biosimilar approved for Rituxan, which is one of the first monoclonal antibody cancer treatments approved by the FDA. Ruxience is now the 22nd biosimilar product available to patients.

Biosimilar approvals are contingent on the fact that they are highly similar to a reference product, or a product that has already been approved by the FDA. Biosimilars must also have no significant differences in safety or efficacy from the reference product.

In this instance, the FDA’s approval was based on data from a clinical comparative study, REFLECTIONS B3281006, which showed biosimilarity of Ruxience to Rituxan. The medication showed no clinically meaningful differences in safety or efficacy compared with Rituxan in patients with CD20-positive, low tumor burden follicular lymphoma.

What Does This Mean for Patients?

Biosimilars have significantly changed the health care industry over the last 10 years — particularly in making cancer treatment financially sustainable.

“Patients with CD-20 positive lymphoma and CLL need more options for treatment, and this latest approval adds to the arsenal of therapies, while introducing more competition into the marketplace, which will hopefully bring costs down for patients,” said Greenberger. “In particular, rituximab is now approved for combination with other on-patent oral therapies for CLL. What used to be therapy with two on-patent, expensive drugs should now be less expensive and create better options especially for patients with limited financial means.”

Innovations in treatment, such as the biosimilar approval, are something patients with cancer can look forward to, he added.

“In the future, a much more detailed molecular understanding of patients with CLL and (non-Hodgkin lymphomas) will allow us to bring the right medicine to the right patient at the right time,” said Greenberger. “(The Leukemia & Lymphoma Society’s) vision is to cure the patient on the first round of therapy instead of going through multiple therapies at great inconvenience and cost to the patient and health care system.”

To read more about the indications for Ruxience, check out our breaking news story.

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