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Biologics/ Biosimilars

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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/28301793/advances-in-rheumatoid-arthritis
#4
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
#5
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/28288790/establishment-of-the-first-who-international-standard-for-etanercept-a-tnf-receptor-ii-fc-fusion-protein-report-of-an-international-collaborative-study
#6
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
#7
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/28280299/a-practical-guide-about-biosimilar-data-for-health-care-providers-treating-inflammatory-diseases
#8
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/28265837/update-on-biosimilars-in-rheumatology
#9
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
#10
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
#11
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
https://www.readbyqxmd.com/read/28258517/the-language-of-biosimilars-clarification-definitions-and-regulatory-aspects
#12
REVIEW
Paul Declerck, Romano Danesi, Danielle Petersel, Ira Jacobs
Biologic therapies have revolutionized treatment of a number of diseases. Patents and exclusivity for a number of biologics are expiring. This has created the opportunity for the development and approval of biosimilars. Biosimilars are biologic products developed using a step-wise approach to result in a biologic that demonstrates no clinically meaningful differences in terms of quality attributes, efficacy, safety, and immunogenicity compared with an existing licensed, originator biologic. As more biosimilars receive regulatory approval and reach the market, it is increasingly important for healthcare providers to understand the terminology about biosimilars...
March 4, 2017: Drugs
https://www.readbyqxmd.com/read/28255229/biosimilars-and-the-extrapolation-of-indications-for-inflammatory-conditions
#13
REVIEW
John Rp Tesser, Daniel E Furst, Ira Jacobs
Extrapolation is the approval of a biosimilar for use in an indication held by the originator biologic not directly studied in a comparative clinical trial with the biosimilar. Extrapolation is a scientific rationale that bridges all the data collected (ie, totality of the evidence) from one indication for the biosimilar product to all the indications originally approved for the originator. Regulatory approval and marketing authorization of biosimilars in inflammatory indications are made on a case-by-case and agency-by-agency basis after evaluating the totality of evidence from the entire development program...
2017: Biologics: Targets & Therapy
https://www.readbyqxmd.com/read/28237527/a-survey-of-pharmacists-knowledge-and-views-of-biosimilars-in-quebec-and-france
#14
A Adé, O Bourdon, J-F Bussières
OBJECTIVE: The objective of this study was to survey pharmacists' knowledge and views of biosimilars in Quebec and France. METHODS: An online and anonymous survey was conducted. The survey was divided into two parts including: (1) ten multiple choice questions on main characteristics that distinguish biosimilars from generic drugs; (2) fifteen statements on biosimilars key issues (interchangeability, immunogenicity risk management…). Pharmacists were asked to indicate their level of agreement to these statements using a 5-item Likert scale...
February 22, 2017: Annales Pharmaceutiques Françaises
https://www.readbyqxmd.com/read/28236776/evolving-landscape-of-human-epidermal-growth-factor-receptor-2-positive-breast-cancer-treatment-and-the-future-of-biosimilars
#15
REVIEW
Christian Jackisch, Philip Lammers, Ira Jacobs
Human epidermal growth factor receptor 2-positive (HER2+) breast cancer comprises approximately 15%-20% of all breast cancers and is associated with a poor prognosis. The introduction of anti-HER2 therapy has significantly improved clinical outcomes for patients with HER2+ breast cancer, and multiple HER2-directed agents (ie, trastuzumab, pertuzumab, lapatinib, and ado-trastuzumab emtansine [T-DM1]) are approved for clinical use in various settings. The treatment landscape for patients with HER2+ breast cancer is continuing to evolve...
April 2017: Breast: Official Journal of the European Society of Mastology
https://www.readbyqxmd.com/read/28230618/biopharmaceuticals-reference-products-and-biosimilars-to-treat-inflammatory-diseases
#16
Ann Gils, Antonio Bertolotto, Denis Mulleman, Theodora Bejan-Angoulvant, Paul J Declerck
Biopharmaceuticals are primarily therapeutic proteins developed to perform specific functions by acting on the disease pathophysiology. Compared to low molecular chemically synthesized drugs, production of biopharmaceuticals is much more complex and routes of administration and pharmacokinetics differ. Biopharmaceuticals are blockbusters in the treatment of inflammatory diseases such as psoriasis, multiple sclerosis, rheumatic diseases, and inflammatory bowel diseases, and the introduction of these drugs has revolutionized treatment...
February 20, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28214924/characteristics-and-outcomes-of-rheumatoid-arthritis-patients-who-started-biosimilar-infliximab
#17
Yoon-Kyoung Sung, Soo-Kyung Cho, Dam Kim, Soyoung Won, Chan-Bum Choi, So-Young Bang, Seung-Jae Hong, Hyoun Ah Kim, Eun-Mi Koh, Hye-Soon Lee, Chang-Hee Suh, Dae-Hyun Yoo, Sang-Cheol Bae
To compare the characteristics of rheumatoid arthritis (RA) patients receiving either biosimilar or originator infliximab and to identify the effectiveness and safety of biosimilar infliximab in RA patients in real-world practice. RA patients who started either biosimilar or originator infliximab were selected using the prospective biologic disease-modifying anti-rheumatic drugs (DMARDs) registry: BIOlogics Pharmacoepidemiologic StudY (BIOPSY). Baseline characteristics of the two groups were compared, and short-term treatment outcomes, including DAS28-ESR and HAQ-DI scores, were compared after initiation of biosimilar or originator infliximab...
February 18, 2017: Rheumatology International
https://www.readbyqxmd.com/read/28197999/parallel-experimental-design-and-multivariate-analysis-provides-efficient-screening-of-cell-culture-media-supplements-to-improve-biosimilar-product-quality
#18
David Brühlmann, Michael Sokolov, Alessandro Butté, Markus Sauer, Jürgen Hemberger, Jonathan Souquet, Hervé Broly, Martin Jordan
Rational and high-throughput optimization of mammalian cell culture media has a great potential to modulate recombinant protein product quality. We present a process design method based on parallel design-of-experiment (DoE) of CHO fed-batch cultures in 96-deepwell plates to modulate monoclonal antibody (mAb) glycosylation using medium supplements. To reduce risk of losing valuable information in an intricate joint screening, 17 compounds were separated into five different groups, considering their mode of biological action...
February 15, 2017: Biotechnology and Bioengineering
https://www.readbyqxmd.com/read/28188909/extensive-preclinical-evaluation-of-an-infliximab-biosimilar-candidate
#19
M A Velasco-Velázquez, N Salinas-Jazmín, E Hisaki-Itaya, L Cobos-Puc, W Xolalpa, G González, A Tenorio-Calvo, N Piña-Lara, L C Juárez-Bayardo, L F Flores-Ortiz, E Medina-Rivero, N O Pérez, S M Pérez-Tapia
Infliximab is therapeutic monoclonal antibody (mAb) against TNF-α employed in the treatment of immunoinflammatory diseases. The development of biosimilar mAbs is a global strategy to increase drug accessibility and reduce therapy-associated costs. Herein we compared key physicochemical characteristics and biological activities produced by infliximab and infliximab-Probiomed in order to identify functionally relevant differences between the mAbs. Binding of infliximab-Probiomed to TNF-α was specific and had kinetics comparable to that of the reference product...
February 7, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28183342/rheumatology-around-the-world-perspectives-from-australia-and-new-zealand
#20
EDITORIAL
Fiona M F McQueen
Rheumatology continues to be an exciting and vibrant specialty for specialists practising in New Zealand and Australia. Clinicians follow treat-to-target regimens to manage peripheral and axial inflammatory arthritides using conventional and biological agents, which have revolutionised management of rheumatic disease over the past two decades. However, optimal clinical practice has significant pharmacoeconomic implications which impact on health funding at a national level, and the advent of biosimilars is keenly awaited...
February 10, 2017: Arthritis Research & Therapy
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