FDA Approves First Biosimilar to Treat Non-Hodgkin Lymphoma

The Food and Drug Administration (FDA) approved Truxima (rituximab-abbs) — the first biosimilar of Rituxan (rituximab) – to treat adults with CD20-positive, B-cell non-Hodgkin lymphoma (NHL).

Truxima can be used as a single agent or in conjunction with chemotherapy, according to the agency, and the approval is for the following indications:

• relapsed or refractory, low-grade or follicular, CD20-positive B-cell NHL as a single agent;
• previously untreated follicular, CD20-positive, B-cell NHL in combination with a frontline chemotherapy and for patients who achieved a complete or partial response to Rituxan plus chemotherapy as single-agent maintenance therapy; and
• stable, low-grade CD20-positive, B-cell NHL as a single agent after frontline cyclophosphamide, vincristine and prednisone therapy, known as CVP.

A biosimilar is a biological product that, through a series of trials, is shown to be extremely similar to and have no clinically meaningful difference from a reference product, which, in this case, is Rituxan. Once on the market, they are typically at a lower price point.

“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. Our goal is to promote competition that can expand patient access to important medicines,” FDA commissioner Scott Gottlieb, M.D., said in a statement.

Much evidence was reviewed leading up to Truxima’s approval, including extensive structural and functional characterization, as well as animal, human, clinical data and other clinical data, which showed that the agent is similar to Rituxan. However, patients and providers should note that the agent is approved as a biosimilar, not an interchangeable drug.

Truxima’s most common side effects include infusion reactions, fever, abnormally low level of lymphocytes, chills, infection and weakness. Patients should also be monitored for tumor lysis syndrome, cardiac events, kidney damage and bowel obstruction and perforations. Patients should not receive vaccines when being treated with the drug, and pregnant women are advised not to take Truxima.

Both Truxima and Rituxan have a boxed warning to alert providers about serious risks, including fatal infusion reactions, severe skin and mouth reactions, Hepatitis B reactivation which can lead to liver issues or death, as well as Progressive Multifocal Leukoencephalopathy — a rare, but serious brain infection.

Truxima is joining the ranks of more than a dozen other biosimilars that are approved by the FDA. Most recently in the cancer space, a biosimilar was approved for Neulasta to decrease the rates of infections in patients.

“The Truxima approval is our third biosimiliar approval in the past month. The growing pipeline of biosimilars is encouraging. We’re seeing more biosimilar drugs gain market share as this industry matures. We’ll continue to make sure biosimilar medications are evaluated efficiently through a process that makes certain that these new medicines meet the FDA’s rigorous standards for approval,” Gottlieb said.