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Rituximab Biosimilar

Frederick W Thielen, Nasuh C Büyükkaramikli, Rob Riemsma, Debra Fayter, Nigel Armstrong, Ching-Yun Wei, Vanesa Huertas Carrera, Kate Misso, Gill Worthy, Jos Kleijnen, Isaac Corro Ramos
The National Institute for Health and Care Excellence (NICE), as part of the institute's single technology appraisal (STA) process, invited the company that makes obinutuzumab (Roche Products Limited) to submit evidence of the clinical and cost effectiveness of the drug in combination with chemotherapy, with or without obinutuzumab as maintenance therapy for adult patients with untreated, advanced follicular lymphoma (FL) in the UK. Kleijnen Systematic Reviews Ltd (KSR), in collaboration with Erasmus University Rotterdam, was commissioned to act as the Evidence Review Group (ERG)...
December 13, 2018: PharmacoEconomics
Sanjay Kumar Singh, Santosh Pokalwar, Sandip Bose, Shivika Gupta, Suhani Almal, Ranjit Sudhakar Ranbhor
Background: Cell surface protein, CD20, is extensively expressed on the surface of B cells. Antibodies targeting CD20 protein are being used to treat B-cell malignancies and B-cell mediated autoimmune diseases. Considering the cost of therapy with innovator monoclonal antibodies for these diseases, development of biosimilar products for the treatment of such diseases provides affordable solution to rising healthcare costs. Materials and Methods: Reference products of rituximab (six batches) were procured and stored as per manufacturer's instructions...
2018: Biologics: Targets & Therapy
Ciara L Freeman, Laurie Sehn
PURPOSE OF REVIEW: Since its initial approval in 1997, rituximab has revolutionized the treatment of CD20-positive lymphoproliferative disorders. Now, over two decades later, second-generation molecules are emerging that may have key biological advantages compared to rituximab, as well as biosimilars that may be more cost-effective. Clinicians, health policy makers, and payers will now need to critically appraise the available evidence for these competitors and decide which anti-CD20 to use...
November 27, 2018: Current Oncology Reports
Michinori Ogura, Juan Manuel Sancho, Seok-Goo Cho, Hideyuki Nakazawa, Junji Suzumiya, Gayane Tumyan, Jin Seok Kim, Anne Lennard, José Mariz, Nikolai Ilyin, Wojciech Jurczak, Aurelio Lopez Martinez, Olga Samoilova, Edvard Zhavrid, Eduardo Yañez Ruiz, Marek Trneny, Leslie Popplewell, Bertrand Coiffier, Christian Buske, Won-Seog Kim, Sang Joon Lee, Sung Young Lee, Yun Ju Bae, Larry W Kwak
BACKGROUND: Studies in patients with rheumatoid arthritis and advanced follicular lymphoma have shown that CT-P10, a rituximab biosimilar, has equivalent or non-inferior efficacy and pharmacokinetics to rituximab. We aimed to assess the therapeutic equivalence of single-agent CT-P10 and rituximab in patients with newly diagnosed low-tumour burden follicular lymphoma. METHODS: In this ongoing, randomised, double-blind, parallel-group, active-controlled, phase 3 trial, adult patients (≥18 years) with stage II-IV low-tumour-burden follicular lymphoma were randomly assigned (1:1) using an interactive web or voice response system stratified by region, stage, and age to CT-P10 or US-sourced rituximab...
November 2018: Lancet Haematology
Derek J Hodgson, Houman Ghasriani, Yves Aubin
The advent of monoclonal antibody biosimilar products has stimulated the development of analytical methods that can better characterize an important quality attribute, namely the higher order structure (HOS). Here, we propose a simple approach based on heteronuclear 2D NMR techniques at natural abundance for generating spectral fingerprints of the HOS at high resolution. We show that the proposed method can assess the HOS of six therapeutic products, adalimumab (Humira®), bevacizumab (Avastin®), infliximab (Remicade®), rituximab (Rituxan®), trastuzumab (Herceptin®), and Etanercept (Enbrel®)...
January 30, 2019: Journal of Pharmaceutical and Biomedical Analysis
Hans-Peter Tony, Klaus Krüger, Stanley Cohen, Hendrik Schulze-Koops, Alan Kivitz, Slawomir Jeka, Edit Vereckei, Liyi Cen, Laura Kring, Dmitrij Kollins
OBJECTIVES: Comparable clinical efficacy of the rituximab biosimilar GP2013 and reference rituximab (RTX) has been established in blinded randomized trials. However, when switching from a reference biologic to a biosimilar, potential safety implications are often an important consideration. Therefore, this study evaluated the safety of switching from reference RTX to rituximab biosimilar GP2013, compared with treatment continuation with reference RTX, in patients with rheumatoid arthritis (RA)...
October 8, 2018: Arthritis Care & Research
Manoela Manova, Alexandra Savova, Maria Vasileva, Silvia Terezova, Maria Kamusheva, Daniela Grekova, Valentina Petkova, Guenka Petrova
Biological products for treatment of rheumatoid arthritis usually are cost effective for healthcare systems in Europe, but they are huge financial burden due to the high number of patients and the significant budget impact. The expected saving from introduction on the market of biosimilars are significant and are linked to better access and affordability. The aim of this study was to conduct comparative price analysis of biological products for rheumatoid arthritis therapy among seventeen EU countries. The point of view is that of the Bulgarian pricing and reimbursement system and the chosen countries are those from external reference basket for prices comparison at manufacturing level...
2018: Frontiers in Pharmacology
Sofia B Santos, José M Sousa Lobo, Ana C Silva
This article provides an updated review of the biosimilar medicines approved for cancer therapy in the European Union (EU). First we discuss the most relevant aspects for the development and approval of biosimilar medicines. We then present the oncological biosimilar drugs currently used, which include epoetins (alpha and zeta), filgrastim, and monoclonal antibodies (rituximab, trastuzumab and bevacizumab). Among the clinical applications of biosimilar medicines, cancer therapy remains the main target area and more approved biosimilars are expected over the next few years, providing cost-effective drugs to more patients...
September 19, 2018: Drug Discovery Today
Gholamreza Toogeh, Mohammad Faranoush, Seyed Mohsen Razavi, Hassan Jalaeikhoo, Abolghasem Allahyari, Mohammad Reza Ravanbod, Fariba Zarrabi, Vahid Fallahazad, Ehsan Rezaei Darzi, Shadi Sadat Alizadeh Fard
BACKGROUND: Chronic lymphocytic leukemia (CLL) is characterized by accumulation of B cells in blood, lymphoid tissues and bone marrow. Addition of rituximab to CLL chemotherapy regimens has been associated with improved survival. The aim of this study was to establish efficacy and safety of Zytux™ in comparison to MabThera® in treatment of CLL. MATERIALS AND METHODS: Seventy CLL patients who met the criteria for entering the study were randomized into two groups (35 patients in each group)...
April 1, 2018: International Journal of Hematology-oncology and Stem Cell Research
Won Park, Ljubinka Božić-Majstorović, Dragana Milakovic, Alfredo Berrocal Kasay, Elias Chalouhi El-Khouri, Fedra Irazoque-Palazuelos, Francisco Fidencio Cons Molina, Pavel Shesternya, Pedro Miranda, Francisco G Medina-Rodriguez, Piotr Wiland, Slawomir Jeka, Jose Chavez-Corrales, Olena Garmish, Thomas Linde, Dmytro Rekalov, Pawel Hrycaj, Andreas Krause, Natalia Fomina, Olena Piura, Mauricio Abello-Banfi, Chang-Hee Suh, Seung Cheol Shim, Sang Joon Lee, Sung Young Lee, Sung Hwan Kim, Dae Hyun Yoo
This multinational, randomized, double-blind trial, ( identifier NCT02149121) was designed to demonstrate equivalence in pharmacokinetics and efficacy between CT-P10 and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA). Adults with active RA were treated with CT-P10, United States-sourced RTX (US-RTX; Rituxan®), or European Union-sourced RTX (EU-RTX; MabThera®) at weeks 0 and 2. The co-primary pharmacokinetic endpoints were area under the serum concentration-time curve (AUC) from time zero to last measurable concentration (AUC0-last ), AUC from time zero to infinity (AUC0-∞ ), and maximum concentration (Cmax ) after two infusions...
August 2018: MAbs
Timothy M Pierpont, Candice B Limper, Kristy L Richards
Rituximab is a chimeric mouse/human monoclonal antibody (mAb) therapy with binding specificity to CD20. It was the first therapeutic antibody approved for oncology patients and was the top-selling oncology drug for nearly a decade with sales reaching $8.58 billion in 2016. Since its initial approval in 1997, it has improved outcomes in all B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, and chronic lymphocytic leukemia. Despite widespread use, most mechanistic data have been gathered from in vitro studies while the roles of the various response mechanisms in humans are still largely undetermined...
2018: Frontiers in Oncology
Maria Greenwald, John Tesser, K Lea Sewell
A biosimilar is a biologic product that is highly similar to a licensed biologic ("originator") such that there are no clinically meaningful differences in safety, purity, or potency between the biosimilar and the originator. As patent protection and data exclusivity for the biologic rituximab expire, several potential biosimilars to rituximab are in development, which could soon lead to the availability of numerous rituximab biosimilars. Biosimilars are evaluated using thorough and rigorous analyses of the potential biosimilar versus the originator biological to confirm similar structure, function, and clinical efficacy as well as safety...
2018: Arthritis
Ciara L Freeman, Laurie H Sehn
While rituximab has dramatically improved outcomes for patients with CD20+ malignancies for two decades, responses are not universal and resistance can develop. Obinutuzumab was developed to potentiate activity and overcome resistance. Pre-clinical data suggests obinutuzumab is superior to rituximab at effecting B cell depletion; however recent phase III clinical trial results have been mixed. The decision of which antibody to employ will probably be further complicated by the approval of a subcutaneous preparation of rituximab and several anti-CD20 biosimilars...
July 2018: British Journal of Haematology
Paul Declerck, Georgios Bakalos, Elias Zintzaras, Bettina Barton, Thomas Schreitmüller
PURPOSE: With the introduction of biosimilars of anticancer monoclonal antibodies (mAbs) in oncology, physicians are potentially confronted with the question whether it is clinically adequate to switch patients who are clinically stable on treatment with the reference product to a newly available biosimilar (or vice versa/from 1 biosimilar to another). For a proper impact assessment of switching, robust, product-specific, and clinically relevant evidence should be required, ideally including data from appropriately designed switching studies...
May 2018: Clinical Therapeutics
Stanley B Cohen, Rubén Burgos-Vargas, Paul Emery, Bo Jin, Carol Cronenberger, María-Dolores Vázquez-Abad
OBJECTIVE: This extension study provided continued treatment to subjects with active rheumatoid arthritis who had participated for ≥16 weeks in a pharmacokinetic similarity study of PF-05280586 (potential rituximab biosimilar). Objectives were to evaluate overall pharmacokinetics, pharmacodynamics, immunogenicity, safety, and tolerability of PF-05280586 after transition from rituximab reference products to PF-05280586, and follow-up of biomarker and efficacy assessments. METHODS: Subjects were offered ≤3 additional courses of treatment of PF-05280586, with or without a single transition from rituximab in Europe (rituximab-EU; MabThera) or the US (rituximab-US; Rituxan) to PF-05280586...
November 2018: Arthritis Care & Research
Gaurav Prakash, Pankaj Malhotra, Alka Khadwal, Deepesh Lad, Vikas Suri, Savita Kumari, Subhash Varma
There is paucity of data on infusion related hypersensitivity reactions (IRHR) pattern of bio-similar rituximab in B-cell lymphoma patients. As bio-similar molecules are independently developed monoclonal antibodies, they are likely to differ in immunogenicity and therefore, the hypersensitivity data of the innovator rituximab may not be directly applicable to patients treated with the biosimilar rituximab molecule. We analysed our data of 256 patients of B cell lymphoid neoplasm who received bio-similar rituximab (Reditux) based chemo-immunotherapy for their treatment...
April 2018: Indian Journal of Hematology & Blood Transfusion
Kyoung Hoon Lee, Jihun Lee, Jin Soo Bae, Yeon Jung Kim, Hyun Ah Kang, Sung Hwan Kim, So Jung Lee, Ki Jung Lim, Jung Woo Lee, Soon Kwan Jung, Shin Jae Chang
CT-P10 (Truxima™) was recently approved as the world's first rituximab biosimilar product in the European Union (EU) and South Korea. To demonstrate biosimilarity of CT-P10 with the reference medicinal product (RMP), extensive 3-way similarity assessment has been conducted between CT-P10, EU-Rituximab and US-Rituximab, focusing on the physicochemical and biological quality attributes. A multitude of state-of-the-art analyses revealed that CT-P10 has identical primary and higher order structures compared to the original product...
April 2018: MAbs
P Ganesan, T G Sagar, K Kannan, V Radhakrishnan, S Rajaraman, A John, S Sundersingh, V Mahajan, T S Ganesan
INTRODUCTION: Rituximab (R)-CHOP improves survival over CHOP in diffuse large B-cell lymphoma (DLBCL). The availability of biosimilar rituximab in India has increased access of this drug. We report on the impact of treatment on outcomes with special emphasis on the impact of biosimilar rituximab and radiation. METHODS: Outcomes of adults (age 15-60 years) treated with CHOP+/- Rituximab radiation were analyzed retrospectively to look at baseline features, treatment, and event-free and overall survival (EFS and OS)...
April 2017: Indian Journal of Cancer
J Braun, H M Lorenz, U Müller-Ladner, M Schneider, H Schulze-Koops, Ch Specker, A Strangfeld, U Wagner, T Dörner
The treatment of rheumatic diseases with bioloics has significantly improved the prognosis of patients. Currently, there are 13 preparations available in Germany for the treatment of patients with inflammatory rheumatic diseases. These original preparations generally have-depending on the individual country-15 years of patent protection. As soon as the patent has expired, approved biosimilars can be brought into use. For the approval of a biosimilar, authorities such as the European Medical Agency or the American Food and Drug Administration require proof of the best possible comparability with respect to efficacy and safety in comparison to the original or reference product...
February 2018: Zeitschrift Für Rheumatologie
Myrna Candelaria, Derlis Gonzalez, Francisco Javier Fernández Gómez, Alexandra Paravisini, Ana Del Campo García, Luis Pérez, Bernardo Miguel-Lillo, Susana Millán
PURPOSE: The main objective was to quantify any potential differences in pharmacokinetic (PK) parameters (AUC and Cmax ) between RTXM83, a proposed rituximab biosimilar, and its reference product, using a population PK model approach. METHODS: Rituximab PK and PD data were obtained from a randomized, double-blind, phase III clinical study (RTXM83-AC-01-11) in patients with diffuse large B-cell lymphoma (DLBCL) that received 375 mg/m2 intravenous RTXM83 or its reference product with CHOP regimen, every 3 weeks, for six cycles...
March 2018: Cancer Chemotherapy and Pharmacology
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