FDA News

FDA approves Ruxience, biosimilar to Rituxan, for blood cancers, autoimmune conditions

The FDA approved rituximab-pvvr, a biosimilar to rituximab, for multiple indications.

Rituximab-pvvr (Ruxience, Pfizer) is the second biosimilar to rituximab (Rituxan; Genentech, Biogen) to be approved in the United States.

Four of the indications for rituximab-pvvr apply to its use for adults with CD20-positive B-cell non-Hodgkin lymphoma. They include:

Monotherapy for those with relapsed or refractory, low-grade or follicular disease;

Use in combination with first-line chemotherapy for those with previously untreated disease, and as single-agent maintenance therapy for those who achieve complete or partial response to a rituximab product in combination with chemotherapy;

Single-agent therapy for nonprogressing disease after first-line cyclophosphamide, vincristine and prednisone chemotherapy; and

Use in combination with CHOP- or other anthracycline-based chemotherapy regimens for patients with previously untreated diffuse large B-cell, CD20-positive non-Hodgkin lymphoma.

The approval also applies to use of rituximab-pvvr in combination with fludarabine and cyclophosphamide for patients with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia.

In addition, rituximab-pvvr is the first biosimilar approved for treatment of adults with granulomatosis with polyangiitis — formerly called Wagener’s granulomatosis — and microscopic polyangiitis. These indications call for the agent to be used in combination with glucocorticoids.

There are now 22 FDA-approved biosimilar products in the United States.

Biosimilars are biological products that have been shown to be highly similar to an already-approved biological product. The pre-approved agents are called reference products.

Biosimilars must have no clinically meaningful differences from their reference products with regard to effectiveness or safety. Only small differences in clinically inactive components are allowable with biosimilar products.

The most common side effects reported among patients treated with rituximab-pvvr are infusion-related reactions, fever, lymphopenia, neutropenia, chills, infection, weakness, nausea, diarrhea, headache, muscle spasms, anemia and peripheral edema.

The labeling for rituximab-pvvr — like its reference product — includes a boxed warning that alerts patients and health care professionals about elevated risks for fatal infusion-related reactions, severe mouth and skin reactions, hepatitis B virus reactivation and progressive multifocal leukoencephalopathy.

The FDA approved rituximab-pvvr, a biosimilar to rituximab, for multiple indications.

Rituximab-pvvr (Ruxience, Pfizer) is the second biosimilar to rituximab (Rituxan; Genentech, Biogen) to be approved in the United States.

Four of the indications for rituximab-pvvr apply to its use for adults with CD20-positive B-cell non-Hodgkin lymphoma. They include:

Monotherapy for those with relapsed or refractory, low-grade or follicular disease;

Use in combination with first-line chemotherapy for those with previously untreated disease, and as single-agent maintenance therapy for those who achieve complete or partial response to a rituximab product in combination with chemotherapy;

Single-agent therapy for nonprogressing disease after first-line cyclophosphamide, vincristine and prednisone chemotherapy; and

Use in combination with CHOP- or other anthracycline-based chemotherapy regimens for patients with previously untreated diffuse large B-cell, CD20-positive non-Hodgkin lymphoma.

The approval also applies to use of rituximab-pvvr in combination with fludarabine and cyclophosphamide for patients with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia.

In addition, rituximab-pvvr is the first biosimilar approved for treatment of adults with granulomatosis with polyangiitis — formerly called Wagener’s granulomatosis — and microscopic polyangiitis. These indications call for the agent to be used in combination with glucocorticoids.

There are now 22 FDA-approved biosimilar products in the United States.

Biosimilars are biological products that have been shown to be highly similar to an already-approved biological product. The pre-approved agents are called reference products.

Biosimilars must have no clinically meaningful differences from their reference products with regard to effectiveness or safety. Only small differences in clinically inactive components are allowable with biosimilar products.

The most common side effects reported among patients treated with rituximab-pvvr are infusion-related reactions, fever, lymphopenia, neutropenia, chills, infection, weakness, nausea, diarrhea, headache, muscle spasms, anemia and peripheral edema.

The labeling for rituximab-pvvr — like its reference product — includes a boxed warning that alerts patients and health care professionals about elevated risks for fatal infusion-related reactions, severe mouth and skin reactions, hepatitis B virus reactivation and progressive multifocal leukoencephalopathy.