Truxima fda. The FDA approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as TRUXIMA, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL. Relapsed or refractory, low grade or TRUXIMA should only be administered by a healthcare professional with appropriate medical support to manage severe infusion-related reactions that can be fatal if they occur (2. C. While both drugs are CD20-directed cytolytic antibodies used to treat non-Hodgkin’s lymphoma (NHL), Rituxan has additional FDA-approved indications beyond NHL. Jun 18, 2025 · Detailed dosage guidelines and administration information for Truxima (rituximab-abbs). (KRX:068270) and Teva Pharmaceutical Industries Limited (NYSE and TASE: TEVA) today announced that the Food and Drug Administration (FDA) has approved TRUXIMA® (rituximab-abbs), a monoclonal antibody (mAb) biosimilar to RITUXAN®1 (rituximab) for the treatment of adult patients in three indications: CONTENT OF LABELING As soon as possible, but no later than 14 days from the date of this letter, submit, via the FDA automated drug registration and listing system (eLIST), the content of labeling [21 CFR 601. Individual has had two or more prior lines of systemic therapy (Roddie, 2024); OR FDA product labeling for this product includes other, 1. Mar 24, 2025 · Truxima is used to treat non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and granulomatosis with polyangiitis. A new biosimilar, Truxima (rituximab), shows comparable results to the reference medicine, Rituxan (rituximab), and takes FDA one step further toward expanding patient access to medicines. Rituxan was approved by FDA in 1997 (BLA 103705). entered into an exclusive partnership in October 2016 for Teva to commercialize TRUXIMA in the U. Includes: indications, dosage, adverse reactions and pharmacology. : TRUXIMA (rituximab-abbs) is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with: Non-Hodgkin's Lymphoma (NHL) (1. Includes rituximab FDA approvals, mechanism, and interactions. I. The data submitted in this application are adequate to support the conclusion that the manufacture of TRUXIMA is well-controlled and leads to a product that is pure and potent. rituximab (Rituxan) rituximab-abbs (Truxima) rituximab-arrx (Riabni) rituximab-pvvr (Ruxience) Note: Requires Precertification: Precertification of rituximab (Rituxan), rituximab-abbs (Truxima), rituximab-arrx (Riabni This page contains brief information about rituximab and a collection of links to more information about the use of this drug, research results, and ongoing clinical trials. 29, 2018 that FDA approved Truxima (rituximab-abbs), a biosimilar referencing Roche’s anti-cancer biologic, Rituxan (rituximab). g. The FDA has approved Celltrion and Teva’s rituximab biosimilar, Truxima (rituximab-abbs). On November 28, 2018, the US FDA approved Truxima, the first biosimilar to Rituxan (Rituximab). TRUXIMA is a biosimilar of the drug Rituxan (rituximab), for the treatment of adults with GPA and MPA. Rituximab is given by IV infusion by a healthcare provider. Call your doctor for medical advice about side effects. O. FDA D. In patients who develop reactivation of HBV while on TRUXIMA, immediately discontinue TRUXIMA and any concomitant chemotherapy, and institute appropriate treatment. It was originally approved by the U. The Compendium lists the appropriate drugs and biologics for specific cancers using US Food and Drug Administration (FDA)-approved disease indications and specific NCCN panel recommendations. Specific care and treatment may vary depending on individual need and Truxima was approved by the FDA in November of last year to treat adults with CD20-positive, B-cell non-Hodgkin lymphoma (NHL) either as monotherapy or in combination with chemotherapy. Nov 28, 2024 · Easy-to-read patient tips for Truxima covering how it works, benefits, risks, and best practices. Medical Necessity Plans Riabni (rituximab-arrx), Ruxience (rituximab-pvvr), and Truxima (rituximab-abbs) are the preferred rituximab products. 14(b)] in structured product labeling (SPL) format, as described at FDA. In this case, Truxima targets the CD20 antigen expressed on the surface of pre-B and mature B-lymphocytes. Biologics are complex drugs produced from living cells. Biosimilarity of Truxima has been demonstrated for the condition(s) of use (e. Jan 28, 2026 · Truxima (rituximab-abbs) is a biosimilar to Rituxan (rituximab), meaning it has no clinically meaningful differences from Rituxan in safety, purity, or potency. For California members, note that the materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. and Canada. Celltrion Healthcare and Teva Pharmaceutical Industries Ltd. For Medicare criteria, see Medicare Part B Criteria. TRUXIMA (rituximab-abbs) injection is a sterile, clear to opalescent, colorless to pale yellow, preservative-free solution for intravenous infusion supplied as a carton containing one 100 mg/10 Ruxience, Truxima, and Riabni are indicated for treatment of adult patients with moderate to severe pemphigus vulgaris in combination with glucocorticoids. ) as the first biosimilar to Rituxan (rituximab, Genentech Inc. TRUXIMA, in combination with methotrexate, is indicated for the treatment of adult patients with moderately-to-severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. Food and Drug Administration (FDA) to match all of the reference product’s oncology indications described below. [27][73] Efficacy was evaluated in Inter-B-NHL Ritux 2010, a Interactions, warnings, dosage and more for TRUXIMA- rituximab-abbs injection, solution TRUXIMA is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL. Includes dose adjustments, warnings and precautions. Rituximab(利妥昔单抗)适用症: Rituximab(利妥昔单抗)经过美国食品药品监督管理局 (FDA) 批准,可用于治疗慢性淋巴细胞白血病 (CLL)、某些类型的非霍奇金淋巴瘤 (NHL) 以及某些自身免疫疾病。Rituximab(利妥昔单抗)经常与其他药物联合使用来治疗 Waldenstrom’s macroglobulinemia (华氏巨球蛋白血症,WM),包括联合化疗 Celltrion has seven biosimilars approved by the U. S. The dating period for TRUXIMA 100 mg/10 mL (10 mg/mL) shall be 24 months from the date of manufacture when stored at 2°C to 8°C. Oct 20, 2025 · Learn about the side effects of Truxima (rituximab), from common to rare, for consumers and healthcare professionals. In the last decades, evidence suggesting the direct or indirect involvement of B cells on multiple sclerosis (MS) pathogenesis has accumulated. J7677 Revefenacin inhalation solution, fda-approved final product, non-compounded, administered through DME, 1 microgram J9030 BCG live intravesical instillation, 1 mg J9036 Injection, bendamustine hydrochloride, (Belrapzo/bendamustine), 1 mg J9356 Injection, trastuzumab, 10 mg and Hyaluronidase-oysk Celltrion, Inc. Truxima The proposed proprietary name (Truxima) and the proposed nonproprietary name (rituximab-abbs) are only conditionally accepted for this product until the application is approved. What is TRUXIMA? TRUXIMA is a prescription drug used in adults to treat NHL and CLL. The TRUXIMA® Cost Support Program is available to eligible patients who have been prescribed TRUXIMA and have commercial prescription insurance. Learn about side effects, interactions and indications. These are not all of the possible side effects with TRUXIMA. TRUXIMA (rituximab-abbs) injection is a sterile, clear to opalescent, colorless to pale yellow, preservative-free solution for intravenous infusion. Package insert / product label TRUXIMA (rituximab-abbs) injection is a sterile, clear to opalescent, colorless to pale yellow, preservative-free solution for intravenous infusion. Truxima forms a complex with the CD20 antigen which causes B-cell death (lysis). Insufficient data exist regarding the safety of resuming TRUXIMA treatment in patients who develop HBV reactivation. TRUXIMA is a biologic drug. In May 2019, TRUXIMA was approved by the U. Celltrion developed Truxima (rituximab-abbs, CT-P10) as a proposed biosimilar product to US-licensed Rituxan (rituximab). As soon as possible, but no later than 14 days from the date of this letter, submit, via the FDA automated drug registration and listing system (eLIST), the content of labeling [21 CFR 601. Please see the TRUXIMA full Prescribing Information, including Boxed Warning and Medication Guide. * Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Food and Drug Administration (FDA) has approved TRUXIMA ® (rituximab-abbs), a monoclonal antibody (mAb) biosimilar to RITUXAN ®1 (rituximab) for the treatment of adult patients in three indications: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non On November 28, 2018, the Food and Drug Administration approved Truxima (rituximab-abbs, Celltrion Inc. Coverage will be provided for Riabni, Ruxience, or Truxima contingent on the coverage criteria in the Diagnosis-Specific Criteria section. Información para el paciente sobre Truxima: para qué sirve, dosis, efectos secundarios y cómo usar este medicamento. The First FDA-approved Biosimilar Rituximab - Initial approval in the US, November 2018 TRUXIMA is highly similar to Rituxan (rituximab) for the indications listed below, with no clinically meaningful differences in terms of safety, purity, and potency. Each recommendation is supported by a level of evidence category. 1). TRUXIMA is a type of biologic called a biosimilar Biosimilars are FDA-approved biological products that are highly similar and have no clinically meaningful differences from existing FDA-approved biologic drugs. Actor portrayal. TRUXIMA is not chemotherapy, though it is sometimes used with chemotherapy treatment. TRUXIMA is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Cephalon, Inc. TRUXIMA is a type of biologic called a biosimilar. Brand names include Rituxan, Riabni, Ruxience, and Truxima. You may report side effects to FDA at 1-800-FDA-1088. FDA in 1997 as a single agent to treat patients with B-cell Non-Hodgkin's Lymphoma (NHL), however, has now been approved for a variety of conditions. Celltrion and Teva Pharmaceutical Industries announced on Nov. gov,1 that is identical to the enclosed labeling (text for the Prescribing FDA has approved Truxima (rituximab-abbs), a biosimilar to Roche’s anti-cancer biologic, Rituxan (rituximab). 12(f)] in Microsoft Word format that includes the changes approved in this supplemental application, as well as annual reportable Truxima package insert / prescribing information for healthcare professionals. (NYSE and TASE: TEVA) today announced that the U. Biosimilars are FDA-approved biological products that are highly similar and have no clinically meaningful differences from existing FDA-approved biologic drugs. FDA: INFLECTRA ® (infliximab-dyyb), TRUXIMA ® (rituximab-abbs), HERZUMA ® (trastuzumab-pkrb), VEGZELMA ® (bevacizumab-adcd), YUFLYMA ® (adalimumab-aaty), STEQEYMA ® (ustekinumab-stba), and AVTOZMA ® (tocilizumab-anoh), as well as novel biologic ZYMFENTRA ® (infliximab-dyyb). Rituxan is Roches’ top-selling drug with . indication(s Also within 14 days, amend all pending supplemental applications that include labeling changes for this BLA, including pending “Changes Being Effected” (CBE) supplements, for which FDA has not yet issued an action letter, with the content of labeling [21 CFR 601. 1 important dosing information, 2. The increased amount of data on the efficacy and safety of B-cell-depleting therapies from several The Medical Policies, Medical Benefit Drug Policies, and corresponding update bulletins for UnitedHealthcare Commercial plans are listed below. They contain the same active ingredient and works the same way, but Feb 10, 2025 · Truxima (rituximab-abbs) is not a chemotherapy drug, rather it is a biologic that is targeted toward specific antigens (proteins). (KRX:068270) and Teva Pharmaceutical Industries Ltd. gov,1 that is identical to the enclosed labeling (text for the Prescribing Information and Medication Guide) and Policy Scope of Policy This Clinical Policy Bulletin addresses the following rituximab products for commercial medical plans. 2 recommended dose for … Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with … clinical data that demonstrates Truxima is biosimilar to Rituxan. ) for patients with CD20 During TRUXIMA Therapy: In patients with lymphoid malignancies, during treatment with TRUXIMA monotherapy, obtain complete blood counts (CBC) with differential and platelet counts prior to each TRUXIMA course. Initiation of rituximab (Rituxan®), rituximab-abbs (Truxima®), rituximab-arrx (RiabniTM), or rituximab-pvvr (RuxienceTM) meets the definition of medical necessity when the following are met: In December 2021, the US FDA approved rituximab in combination with chemotherapy for children aged 6 months to 18 years with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia. The dating period for TRUXIMA 500 mg/50 mL (10 mg/mL) shall be 48 months from the date of manufacture when stored at 2°C to 8°C. 1 non–hodgkin's lymphoma (nhl), 2. indication(s * Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Burst Edition: FDA approvals of Rituxan (rituximab) plus chemotherapy for pediatric cancer indications, and Keytruda (pembrolizumab) for adjuvant treatment of Stage IIB or IIC melanoma 3. . Most cases of non-Hodgkin’s lymphoma and chronic lymphocytic leukemia arise May 2, 2025 · Rituximab infusion is used to treat certain leukemias and lymphomas and some non-cancer conditions, such as rheumatoid arthritis, polyangiitis, and pemphigus vulgaris, depending on the brand. Jul 5, 2025 · Get clear safety guidance for Truxima (Rituximab-abbs Intravenous), including warnings, precautions, when to seek medical assistance, and how to use it correctly. I. Nov 28, 2018 · Celltrion, Inc. Jun 23, 2025 · Truxima package insert / prescribing information for healthcare professionals. You may also report side effects to Teva at 1-888-483-8279. The Office of Biotechnology Products, OPQ, CDER, recommends approval of STN 761088 for TRUXIMA (rituximab-abbs) manufactured by Celltrion, Inc. This program is intended for the benefit of patients, not their insurance plans or other third parties. txtzb, jq4vv, 0w08f, icgn, pimcu, dxu2, 8ile, cdccs, bvwb, tb5pyt,