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https://www.readbyqxmd.com/read/28319617/biosimilars-in-psoriasis-the-future-or-not
#1
Roselyn Kellen, Gary Goldenberg
As patents for the biologic agents reach their expiration dates, dermatologists must prepare for the coming of biosimilars. These agents have been deemed "highly similar" to their reference products in a process outlined by the US Food and Drug Administration (FDA). In 2016, the FDA approved 3 biosimilars for various indications including plaque psoriasis and psoriatic arthritis. However, biosimilars are not the same as small-molecule generics because they have a complex manufacturing process that makes it impossible to produce identical products to their reference products...
February 2017: Cutis; Cutaneous Medicine for the Practitioner
https://www.readbyqxmd.com/read/28319603/the-path-of-interchangeability-of-biosimilars-in-pediatric-inflammatory-bowel-disease-quality-before-cost-savings
#2
Dimple Patel, K T Park
The advent of biosimilars in inflammatory bowel disease (IBD) represents an opportunity for cost-savings and increased patient access to effective disease-modifying therapies. While preliminary data in adult IBD and rheumatology patients suggest comparable effectiveness and pharmacokinetics between original biologics and biosimilars, long-term immunogenicity data are unknown. Without this data, conclusions about interchangeability should not be made for pediatric patients with IBD. Children affected by IBD, in particular, are a vulnerable group if automatic substitution and non-medical switching are allowed based on limited data in adult patients...
March 17, 2017: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/28315542/biosimilars-considerations-for-oncology-nurses%C3%A2
#3
Vida Vizgirda, Ira Jacobs
BACKGROUND: Biosimilars are developed to be highly similar to and treat the same conditions as licensed biologics. As they are approved and their use becomes more widespread, oncology nurses should be aware of their development and unique considerations. OBJECTIVES: This article reviews properties of biosimilars; their regulation and approval process; the ways in which their quality, safety, and efficacy are evaluated; their postmarketing safety monitoring; and their significance to oncology nurses and oncology nursing...
April 1, 2017: Clinical Journal of Oncology Nursing
https://www.readbyqxmd.com/read/28306596/biosimilars-implications-for-rheumatoid-arthritis-therapy
#4
Stanley Cohen, Jonathan Kay
PURPOSE OF REVIEW: Abbreviated pathways for the approval of biosimilars have been established in the European Union (EU), the United States, and other countries. Biosimilar TNF inhibitors have been available in South Korea and the EU since 2012 and 2013, respectively, and the first biosimilar infliximab was introduced to the clinic in the United States in November 2016. Five TNF inhibitor biosimilars have now been approved, and many other biosimilars to treat rheumatoid arthritis and other inflammatory diseases are in development...
March 16, 2017: Current Opinion in Rheumatology
https://www.readbyqxmd.com/read/28301793/advances-in-rheumatoid-arthritis
#5
Graeme Jones, Peter Nash, Stephen Hall
There are now eight approved biological disease-modifying antirheumatic drugs (bDMARDs), two biosimilars and one targeted synthetic DMARD in Australia with a number of new products and biosimilars in the pipeline. bDMARDs have excellent efficacy, especially when combined with traditional DMARDs, and a well characterised but manageable safety profile. These expanded therapeutic options have revolutionised patient care and made remission (including drug free remission) a realistic goal. Evidence of a "window of opportunity" that changes the long term phenotype of the disease has been well established, so therapy should be commenced as early as possible in the disease process and a shared care model between general practitioner and rheumatologist provides the best outcomes...
March 20, 2017: Medical Journal of Australia
https://www.readbyqxmd.com/read/28296619/drifts-in-adcc-related-quality-attributes-of-herceptin%C3%A2-impact-on-development-of-a-trastuzumab-biosimilar
#6
Seokkyun Kim, Jinsu Song, Seungkyu Park, Sunyoung Ham, Kyungyeol Paek, Minjung Kang, Yunjung Chae, Heewon Seo, Hyung-Chan Kim, Michael Flores
A biosimilar product needs to demonstrate biosimilarity to the originator reference product, and the quality profile of the latter should be monitored throughout the period of the biosimilar's development to match the quality attributes of the two products that relate to efficacy and safety. For the development of a biosimilar version of trastuzumab, the reference product, Herceptin®, was extensively characterized for the main physicochemical and biological properties by standard or state-of-the-art analytical methods, using multiple lots expiring between March 2015 and December 2019...
March 15, 2017: MAbs
https://www.readbyqxmd.com/read/28293938/effectiveness-and-safety-of-infliximab-biosimilar-ct-p13-in-treating-ulcerative-colitis-a-real-life-experience-in-ibd-primary-centers
#7
Antonio Tursi, Leonardo Allegretta, Stefania Chiri, Nicola Della Valle, Walter Elisei, Giacomo Forti, Roberto Lorenzetti, Giammarco Mocci, Antonio Penna, Giuseppe Pranzo, Cristina Ricciardelli, Marcello Picchio
BACKGROUND: To assess the efficacy and safety of biosimilar infliximab (IFX) IFX CT-P13 in inducing and maintain remission in Ulcerative Colitis (UC) outpatients in Italian primary gastroenterology centers. METHODS: Patients were prospectively assessed at entry, after 8, 12, 24, 36, and therefore 52 weeks. Clinical activity was scored according to the Mayo score. The primary endpoint was reaching of clinical remission (Mayo score ≤2). Several secondary endpoints were clinical response to treatment, reaching of mucosal healing (MH), safety of the drug...
March 14, 2017: Minerva Gastroenterologica e Dietologica
https://www.readbyqxmd.com/read/28291552/clinical-similarity-of-biosimilar-abp-501-to-adalimumab-in-the-treatment-of-patients-with-moderate-to-severe-plaque-psoriasis-a-randomized-double-blind-multicenter-phase-iii-study
#8
Kim Papp, Herve Bachelez, Antonio Costanzo, Peter Foley, Melinda Gooderham, Primal Kaur, Joanna Narbutt, Sandra Philipp, Lynda Spelman, Jolanta Weglowska, Nan Zhang, Bruce Strober
BACKGROUND: ABP 501 is a biosimilar of adalimumab. OBJECTIVE: We sought to compare the efficacy and safety of ABP 501 with adalimumab. METHODS: This 52-week, double-blind study randomized patients with moderate to severe psoriasis to ABP 501 or adalimumab. At week 16, those with 50% or more improvement in Psoriasis Area and Severity Index score from baseline on ABP 501 continued the same treatment, whereas adalimumab-treated patients were rerandomized to adalimumab or ABP 501...
March 10, 2017: Journal of the American Academy of Dermatology
https://www.readbyqxmd.com/read/28290731/a-randomized-double-blind-single-dose-two-arm-parallel-study-comparing-pharmacokinetics-immunogenicity-and-tolerability-of-branded-adalimumab-and-its-biosimilar-lbal-in-healthy-male-volunteers
#9
Kyoung Ryun Park, Hyewon Chung, Sung Mo Yang, SeungHwan Lee, Seo Hyun Yoon, Joo-Youn Cho, In-Jin Jang, Kyung-Sang Yu
OBJECTIVES: This study aimed to compare the pharmacokinetics (PK), immunogenicity, and tolerability of LBAL, a biosimilar of adalimumab, with the originator, Humira(®), in healthy volunteers. METHODS: A randomized, double-blind, single-dose, two-arm, parallel-group study was conducted in 116 healthy subjects. They randomly received a single subcutaneous (SC) 40 mg injection of LBAL or Humira. Blood samples were collected for PK and immunogenicity assessment. PK parameters were determined using the noncompartmental method, and primary endpoint parameters were compared using the point estimates and 90% confidence intervals (CIs) of the geometric mean ratios (GMRs)...
March 14, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28288790/establishment-of-the-first-who-international-standard-for-etanercept-a-tnf-receptor-ii-fc-fusion-protein-report-of-an-international-collaborative-study
#10
Meenu Wadhwa, Chris Bird, Paula Dilger, Peter Rigsby, Haiyan Jia, Marie Emmanuelle Behr Gross
Etanercept, a recombinant human tumor necrosis factor (TNF) receptor Fc fusion protein is an effective treatment option in adults with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or plaque psoriasis and paediatrics with juvenile idiotypic arthritis and plaque psoriasis. Patent expiration in Europe and intense development of various etanercept products worldwide triggered a need for an international reference standard to facilitate determination of biological activity. Therefore, three candidate preparations of etanercept were lyophilized and evaluated in a multi-centre collaborative study comprising twenty eight laboratories from 15 countries for their suitability to serve as an international standard for the bioactivity of TNF receptor II Fc fusion proteins (international nonproprietary name, Etanercept)...
March 10, 2017: Journal of Immunological Methods
https://www.readbyqxmd.com/read/28283512/efficacy-of-biological-disease-modifying-antirheumatic-drugs-a-systematic-literature-review-informing-the-2016-update-of-the-eular-recommendations-for-the-management-of-rheumatoid-arthritis
#11
Jackie L Nam, Kaoru Takase-Minegishi, Sofia Ramiro, Katerina Chatzidionysiou, Josef S Smolen, Désirée van der Heijde, Johannes W Bijlsma, Gerd R Burmester, Maxime Dougados, Marieke Scholte-Voshaar, Ronald van Vollenhoven, Robert Landewé
OBJECTIVES: To update the evidence for the efficacy of biological disease-modifying antirheumatic drugs (bDMARDs) in patients with rheumatoid arthritis (RA) to inform European League Against Rheumatism (EULAR) Task Force treatment recommendations. METHODS: MEDLINE, EMBASE and Cochrane databases were searched for phase III or IV (or phase II, if these studies were lacking) randomised controlled trials (RCTs) published between January 2013 and February 2016. Abstracts from the American College of Rheumatology and EULAR conferences were obtained...
March 10, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28283484/comparative-effectiveness-and-safety-of-erythropoiesis-stimulating-agents-biosimilars-vs-originators-in-clinical-practice-a-population-based-cohort-study-in-italy
#12
Francesco Trotta, Valeria Belleudi, Danilo Fusco, Laura Amato, Alessandra Mecozzi, Flavia Mayer, Massimo Sansone, Marina Davoli, Antonio Addis
OBJECTIVES: To evaluate the benefit/risk profile of epoetin α biosimilar with the erythropoiesis-stimulating agents (ESAs) originators when administered to naïve patients from clinical practice. DESIGN: Population-based observational cohort study. SETTING: All residents in the Lazio Region, Italy, with chronic kidney disease (CKD) or cancer retrieved from the Electronic Therapeutic Plan (ETP) Register for ESA between 2012 and 2014. PARTICIPANTS: Overall, 13 470 incident ESA users were available for the analysis, 8161 in the CKD and 5309 in the oncology setting, respectively...
March 10, 2017: BMJ Open
https://www.readbyqxmd.com/read/28281165/effectiveness-and-safety-of-ct-p13-biosimilar-infliximab-in-patients-with-inflammatory-bowel-disease-in-real-life-at-6%C3%A2-months
#13
F Argüelles-Arias, M F Guerra Veloz, R Perea Amarillo, A Vilches-Arenas, L Castro Laria, B Maldonado Pérez, D Chaaro, A Benítez Roldán, V Merino, G Ramírez, A Caunedo Álvarez, M Romero Gómez
BACKGROUND: CT-P13 is a biosimilar of Remicade(®), an agent approved in some countries for use in inflammatory bowel disease (IBD). Controlled clinical trials have demonstrated the efficacy and safety of CT-P13 in rheumatic diseases, but not in IBD. AIMS: To assess the effectiveness and safety of CT-P13 in IBD patients in real clinical practice. METHODS: This is a prospective observational study in patients with moderate to severe Crohn's disease or ulcerative colitis treated with CT-P13...
March 9, 2017: Digestive Diseases and Sciences
https://www.readbyqxmd.com/read/28280364/biosimilar-retacrit-%C3%A2-epoetin-zeta-in-the-treatment-of-chemotherapy-induced-symptomatic-anemia-in-hematology-and-oncology-in-germany-orheo-non-interventional-study
#14
Christoph Losem, Michael Koenigsmann, Christine Rudolph
BACKGROUND: Symptomatic anemia is a frequent and severe complication of chemotherapy that is commonly treated with erythropoiesis-stimulating agents. The primary objective of this study was to assess the change in hemoglobin levels in patients with chemotherapy-induced anemia (CIA) following treatment with biosimilar Retacrit(®) (epoetin zeta). Secondary objectives included changes in hematologic parameters and tolerability. METHODS: This was a non-interventional, multicenter, long-term observational study that is part of an ongoing surveillance program for epoetin zeta...
2017: OncoTargets and Therapy
https://www.readbyqxmd.com/read/28280299/a-practical-guide-about-biosimilar-data-for-health-care-providers-treating-inflammatory-diseases
#15
REVIEW
Joseph Markenson, Daniel F Alvarez, Ira Jacobs, Carol Kirchhoff
To make informed decisions about the safety, efficacy, and clinical utility of a biosimilar, health care providers should understand the types and be able to analyze data generated from a biosimilar development program. This article reviews the biosimilar guidelines, the biosimilar development process to provide education and context about biosimilarity, and uses examples from infliximab biosimilars to review the terminology and potential types of analyses that may be used to compare potential biosimilars to the originator biologic...
2017: Biologics: Targets & Therapy
https://www.readbyqxmd.com/read/28278727/biosimilars-of-filgrastim-in-autologous-stem-cell-transplantation-certain-differences-for-myeloma-patients-only
#16
Christophe Nicol, Chloé Henry, Marie-Anne Couturier, Pascal Delépine, Céline Tripogney, Caroline Buors, Gaëlle Guillerm, Christian Berthou, Adrian Tempescul, Jean-Christophe Ianotto
No abstract text is available yet for this article.
February 7, 2017: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/28267726/trump-s-pick-rallies-biosimilar-makers
#17
(no author information available yet)
No abstract text is available yet for this article.
March 7, 2017: Nature Biotechnology
https://www.readbyqxmd.com/read/28265837/update-on-biosimilars-in-rheumatology
#18
REVIEW
Adam Rischin, Andrew J K Östör
Biologic agents have become indispensable in the management of autoimmune disease particularly rheumatological conditions. The lives of countless individuals have been improved following treatment with these drugs. Unfortunately, their cost prohibits more widespread use around the globe. This critical issue has been addressed by the introduction of biosimilars into the market. These therapies have been developed to resemble the originator molecule as closely as possible and to increase competition in the therapy area thus allowing costs to be reduced...
March 7, 2017: Inflammopharmacology
https://www.readbyqxmd.com/read/28265349/key-drivers-for-market-penetration-of-biosimilars-in-europe
#19
Cécile Rémuzat, Julie Dorey, Olivier Cristeau, Dan Ionescu, Guerric Radière, Mondher Toumi
Background & Objectives: Potential drivers and barriers of biosimilar uptake were mainly analysed through qualitative approaches. The study objective was to conduct a quantitative analysis and identify drivers of biosimilar uptake of all available biosimilars in the European Union (EU). Methods: A three-step process was established to identify key drivers for the uptake of biosimilars in the top 10 EU member states (MS) pharmaceutical markets (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden, and the UK): (1) literature review to identify incentive policies in place to enhance biosimilars adoption; (2) assessment of biosimilar market dynamics based on database analysis; (3) regression model analysis on price using the following explicative variables: incentive policies; price difference between the biosimilar and the originator product; distribution channel; generic uptake and generic price cut; pharmaceutical expenditure per capita; and market competition...
2017: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/28264816/eular-recommendations-for-the-management-of-rheumatoid-arthritis-with-synthetic-and-biological-disease-modifying-antirheumatic-drugs-2016-update
#20
Josef S Smolen, Robert Landewé, Johannes Bijlsma, Gerd Burmester, Katerina Chatzidionysiou, Maxime Dougados, Jackie Nam, Sofia Ramiro, Marieke Voshaar, Ronald van Vollenhoven, Daniel Aletaha, Martin Aringer, Maarten Boers, Chris D Buckley, Frank Buttgereit, Vivian Bykerk, Mario Cardiel, Bernard Combe, Maurizio Cutolo, Yvonne van Eijk-Hustings, Paul Emery, Axel Finckh, Cem Gabay, Juan Gomez-Reino, Laure Gossec, Jacques-Eric Gottenberg, Johanna M W Hazes, Tom Huizinga, Meghna Jani, Dmitry Karateev, Marios Kouloumas, Tore Kvien, Zhanguo Li, Xavier Mariette, Iain McInnes, Eduardo Mysler, Peter Nash, Karel Pavelka, Gyula Poór, Christophe Richez, Piet van Riel, Andrea Rubbert-Roth, Kenneth Saag, Jose da Silva, Tanja Stamm, Tsutomu Takeuchi, René Westhovens, Maarten de Wit, Désirée van der Heijde
Recent insights in rheumatoid arthritis (RA) necessitated updating the European League Against Rheumatism (EULAR) RA management recommendations. A large international Task Force based decisions on evidence from 3 systematic literature reviews, developing 4 overarching principles and 12 recommendations (vs 3 and 14, respectively, in 2013). The recommendations address conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) (methotrexate (MTX), leflunomide, sulfasalazine); glucocorticoids (GC); biological (b) DMARDs (tumour necrosis factor (TNF)-inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, rituximab, tocilizumab, clazakizumab, sarilumab and sirukumab and biosimilar (bs) DMARDs) and targeted synthetic (ts) DMARDs (Janus kinase (Jak) inhibitors tofacitinib, baricitinib)...
March 6, 2017: Annals of the Rheumatic Diseases
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