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The US Food and Drug Administration today approved Truxima (rituximab-abbs) as the first biosimilar of rituxan (rituximab) for the treatment of adult patients with CD20-positive B-cell non-Hodgkin's lymphoma, either in combination with chemotherapy. Truxima is the first biosimilar approved in the United States for the treatment of non-Hodgkin's lymphoma.
"As part of the FDA's biosimilars action plan, we are developing new policies to make the development of biosimilars more efficient and to give biosimilar manufacturers more opportunities to make their products commercially efficient and competitive. Our goal is to promote competition that can expand patients' access to important drugs, "said FDA Commissioner Scott Gottlieb, MD" Truxima's approval is our third biosimilar approval last month. The growing pipeline of biosimilars is encouraging. We are seeing more and more biosimilar drugs gaining market share as this sector evolves. We will continue to ensure that biosimilars are evaluated effectively through a process to ensure that these new drugs meet the stringent FDA approval standards. "
Truxima is indicated for the treatment of adult patients with:
- B-cell NHL positive for relapsed or refractory or low grade or follicular CD20 as monotherapy;
- Follicular B-cell NHL, CD20-positive, previously untreated, in combination with first-line chemotherapy and, in patients achieving a complete or partial response to a rituximab-based product in combination with chemotherapy, as a treatment single agent maintenance; and
- Non-progressive B-cell NHL (including stable disease), low-grade CD20 positive, monotherapy after first-line chemotherapy with cyclophosphamide, vincristine and prednisone (CVP).
Biologics are usually large complex molecules and can be produced by biotechnology in a living system, such as a microorganism, a plant cell or an animal cell. A biosimilar is an approved biologic based on data showing that it is highly similar to a biological product already approved by the FDA (reference product) and shows no clinically significant difference in terms of safety, purity and power (efficiency and safety). effectiveness) from the reference product, in addition to meeting other criteria defined by law.
Truxima's FDA approval is based on a review of evidence including extensive structural and functional characterization, animal study data, human pharmacokinetic data, clinical immunogenicity data, and other clinical data demonstrating that Truxima is biosimilar to Rituxan. Truxima has been approved as a biosimilar product and not as an interchangeable product.
The most common side effects of Truxima are infusion reactions, fever, abnormally low levels of lymphocytes in the blood (lymphopenia), chills, infection, and weakness (asthenia). Health care professionals are advised to monitor patients for tumor lysis syndrome (complication of treatment where tumor cells are killed at the same time and released into the bloodstream), cardiac adverse effects, kidney damage (renal toxicity) , intestinal occlusions and perforation. Patients should not receive vaccines during treatment. Pregnant or nursing women should not take Truxima as this may affect the development of the fetus or newborn.
Like Rituxan, Truxima's labeling contains a Boxed Warning to alert health professionals and patients to the increased risks of: fatal infusion reactions, serious skin and mouth reactions, some of which are fatal; Reactivation of hepatitis B virus can cause serious liver problems, including liver failure and death; and progressive multifocal leukoencephalopathy, a rare and serious brain infection that can lead to severe disability or death. This product should be used together with the Patient Medication Guide, which provides important information on the use and risks of the drug.
The FDA has authorized Truxima to Celltrion. Rituxan was approved in November 1997 and is manufactured by Genentech.
With the approval of Truxima, the FDA has approved 15 biosimilars. On October 30, 2018, the FDA approved Sandoz's Hyrimoz (adalimumab-adaz) as a biosimilar to Humira (adalimumab) and on November 2, 2018, the FDA approved Cohen's Udenyca (pegfilgrastim-cbqv) as a biosimilar to Neulasta (pegfilgrastim).
The FDA, an agency of the US Department of Health and Social Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety of food products, cosmetics, food supplements, products emitting electronic radiation and the regulation of tobacco products.
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