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Biologics/ Biosimilars

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https://www.readbyqxmd.com/read/27881284/perceived-risks-contra-benefits-of-using-biosimilar-drugs-in-ulcerative-colitis-discrete-choice-experiment-among-gastroenterologists
#1
Petra Baji, László Gulácsi, Petra A Golovics, Barbara D Lovász, Márta Péntek, Valentin Brodszky, Fanni Rencz, Péter L Lakatos
BACKGROUND: In middle-income countries, access to biological therapy is limited in ulcerative colitis in terms of the number of patients and the length of therapy. Because of their cost advantages, biosimilars have the potential to improve access to therapy, but physicians have concerns toward their use because of the lack of evidence from randomized clinical trials. OBJECTIVES: To explore the preferences of gastroenterologists for biosimilar drugs in ulcerative colitis as well as to compare our results with results of previous studies on gastroenterologists' preferences toward biosimilars...
September 2016: Value in Health Regional Issues
https://www.readbyqxmd.com/read/27876365/midyear-commentary-on-trends-in-drug-delivery-and-clinical-translational-medicine-growth-in-biosimilar-complex-injectable-drug-formulation-products-within-evolving-collaborative-regulatory-interagency-fda-ftc-and-doj-practices-and-enforcement
#2
Rodney J Y Ho
Before the 2009 Biologics Price Competition and Innovation Act that enabled the U.S. Federal Drug Administration (FDA) to create the 351(k) Biologic License Application-an abbreviated biosimilar approval process, FDA approved follow-on biomolecule products such as beta-interferon, glucagon, hyaluronidase, and somatropin (human growth hormone) under varying and evolving rules. With the 351(k) Biologic License Application biosimilar approval process in place, currently, there are 4 (licensed in 2015-2016) biosimilars available, namely Neupogen (filgrastim; $1 B/y), Humira (adalumumab; $14...
November 19, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27854156/demonstration-of-physicochemical-and-functional-similarity-between-the-proposed-biosimilar-adalimumab-msb11022-and-humira%C3%A2
#3
Laurent Magnenat, Angelo Palmese, Christèle Fremaux, Fabio D'Amici, Mariagrazia Terlizzese, Mara Rossi, Laurent Chevalet
Biosimilars are biological products that are highly similar to existing products approved by health authorities. Demonstration of similarity starts with the comprehensive analysis of the reference product and its proposed biosimilar at the physicochemical and functional levels. Here, we report the results of a comparative analysis of a proposed biosimilar adalimumab MSB11022 and its reference product, Humira®. Three batches of MSB11022 and up to 23 batches of Humira® were analyzed by a set of state-of-the-art orthogonal methods...
November 17, 2016: MAbs
https://www.readbyqxmd.com/read/27848166/rheumatologists-perceptions-of-biosimilar-medicines-prescription-findings-from-a-french-web-based-survey
#4
Morgane Beck, Bruno Michel, Marie-Christine Rybarczyk-Vigouret, Dominique Levêque, Christelle Sordet, Jean Sibilia, Michel Velten
BACKGROUND: Healthcare cost savings are closely linked to prescribers' confidence in and acceptance of the prescription of biosimilar drugs. OBJECTIVES: The aim of this study was to assess the knowledge, experience and opinions of hospital-based and office-based French rheumatologists with regard to biosimilar medicines and to identify the barriers to and possible options to promote their prescription. METHODS: A web-based, self-administered survey was conducted among French rheumatologists from June 8 to August 2, 2015...
December 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27832357/emerging-biologics-in-inflammatory-bowel-disease
#5
REVIEW
Heyson Chi-Hey Chan, Siew Chien Ng
Early biologic therapy is recommended in patients with inflammatory bowel disease and poor prognostic factors and in those refractory to conventional medications. Anti-tumor necrosis factor (anti-TNF) agents are the most commonly used biologic agents. However, some patients may not have an initial response to anti-TNF therapy, and one-third will develop loss of response over time. Anti-TNF drugs can also be associated with side effects. In addition, the use of biologics is currently limited by their cost, especially in developing countries...
November 10, 2016: Journal of Gastroenterology
https://www.readbyqxmd.com/read/27830969/plasmapheresis-therapy-in-combination-with-tnf-%C3%AE-inhibitor-and-dmards-a-multi-target-method-for-treatment-of-rheumatoid-arthritis
#6
Yongjing Cheng, Feng Yang, Cibo Huang, Jia Huang, Qian Wang, Yingjuan Chen, Yingjue Du, Like Zhao, Ming Gao, Fang Wang
OBJECTIVE: To evaluate the effects of a multi-target method involving plasmapheresis therapy combined with tumor necrosis factor (TNF)-α inhibitor and disease-modifying anti-rheumatic drugs (DMARDs) on disease activity parameters in the treatment of active rheumatoid arthritis (RA). METHODS: Sixty-five patients with active RA were divided into 2 groups according to treatment administered: the plasmapheresis combination therapy group (Plasmapheresis combination group; 38 cases), in which patients received plasmapheresis therapy along with a TNF-α inhibitor (recombinant human tumor necrosis factor-Fc; rhTNFR:Fc; Etanercept biosimilars) and DMARDs, and a TNF-α inhibitor therapy group (biological agent group; 27 cases), in which patients received a TNF-α inhibitor and DMARDs...
November 10, 2016: Modern Rheumatology
https://www.readbyqxmd.com/read/27819248/safety-and-efficacy-of-biosimilars-in-oncology
#7
REVIEW
Huub Schellekens, Josef S Smolen, Mario Dicato, Robert M Rifkin
Biosimilars are considered to be one of the solutions to combat the substantially increasing costs of cancer treatment, and its imminent introduction is expected to expand affordability worldwide. However, biosimilar monoclonal antibodies provide many challenges compared with first-generation biosimilars, growth factors, and hormones, because they have shown only a modest clinical effect, and are often used in combination with other more toxic therapies, making it difficult to design studies that allow appropriate efficacy and safety assessments compared with the original products...
November 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27813877/biosimilars-the-us-regulatory-framework
#8
Leah A Christl, Janet Woodcock, Steven Kozlowski
With the passage of the Biologics Price Competition and Innovation Act of 2009, the US Food and Drug Administration established an abbreviated pathway for developing and licensing biosimilar and interchangeable biological products. The regulatory framework and the technical requirements of the US biosimilars program involve a stepwise approach that relies heavily on analytical methods to demonstrate through a "totality of the evidence" that a proposed product is biosimilar to its reference product. By integrating analytical, pharmacological, and clinical data, each of which has limitations, a high level of confidence can be reached regarding clinical performance...
October 28, 2016: Annual Review of Medicine
https://www.readbyqxmd.com/read/27813422/bioequivalence-safety-and-immunogenicity-of-bi-695501-an-adalimumab-biosimilar-candidate-compared-with-the-reference-biologic-in-a-randomized-double-blind-active-comparator-phase-i-clinical-study-voltaire%C3%A2-pk-in-healthy-subjects
#9
Christopher Wynne, Mario Altendorfer, Ivo Sonderegger, Lien Gheyle, Rod Ellis-Pegler, Susanne Buschke, Benjamin Lang, Deepak Assudani, Sandeep Athalye, Niklas Czeloth
Background This Phase I study (VOLTAIRE™-PK) aimed to evaluate three-way pharmacokinetic similarity (bioequivalence), safety and immunogenicity of BI 695501 (a Humira® [adalimumab] biosimilar candidate) compared with US- and EU-approved Humira in healthy male subjects. Methods Subjects (N = 327) were randomized 1:1:1 to receive one 40 mg subcutaneous dose of BI 695501, US- or EU-approved Humira; safety was assessed for 70 days. Bioequivalence was evaluated using the average bioequivalence method to test if the 90% confidence intervals (CIs) of the geometric means (BI 695501 versus US- and EU-approved Humira) for the primary endpoints were within pre-specified acceptance ranges (80-125%)...
November 4, 2016: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/27798772/awareness-knowledge-and-perceptions-of-biosimilars-among-specialty-physicians
#10
Hillel Cohen, Donna Beydoun, David Chien, Tracy Lessor, Dorothy McCabe, Michael Muenzberg, Robert Popovian, Jonathan Uy
INTRODUCTION: The Biosimilars Forum conducted a survey through an independent organization from November 20, 2015 to January 4, 2016 in order to assess current levels of awareness, knowledge, and perceptions of biosimilars among US specialty physicians who already prescribe biologics. The survey was intended to provide a baseline level of knowledge about biosimilars and will be repeated in 2-3 years in order to monitor trends over time. METHODS: A 19-question survey was created by the Biosimilars Forum and was administered by an independent third party...
October 31, 2016: Advances in Therapy
https://www.readbyqxmd.com/read/27792008/of-patents-and-patent-disputes-the-tnf%C3%AE-patent-files-part-1-humira
#11
Ulrich Storz
This article discusses the patent strategy underlying the world's best selling drug, AbbVie's Humira®. Despite a non-optiimal starting position, AbbVie has established an extensive portfolio to fend off biosimilar competition. This article is the first part of a trilogy that discusses IP issues related to anti-Tumor Necrosis factor α (TNFα) biologics.
October 21, 2016: Human Antibodies
https://www.readbyqxmd.com/read/27771177/cost-effectiveness-analysis-of-treatment-sequence-initiating-with-etanercept-compared-with-leflunomide-in-rheumatoid-arthritis-impact-of-reduced-etanercept-cost-with-patent-expiration-in-south-korea
#12
Sun-Kyeong Park, Seung-Hoo Park, Min-Young Lee, Ji-Hyun Park, Jae-Hong Jeong, Eui-Kyung Lee
PURPOSE: In south Korea, the price of biologics has been decreasing owing to patent expiration and the availability of biosimilars. This study evaluated the cost-effectiveness of a treatment strategy initiated with etanercept (ETN) compared with leflunomide (LFN) after a 30% reduction in the medication cost of ETN in patients with active rheumatoid arthritis (RA) with an inadequate response to methotrexate (MTX-IR). METHODS: A cohort-based Markov model was designed to evaluate the lifetime cost-effectiveness of treatment sequence initiated with ETN (A) compared with 2 sequences initiated with LFN: LFN-ETN sequence (B) and LFN sequence (C)...
October 19, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27758715/efficacy-safety-and-immunogenicity-of-biosimilars-in-inflammatory-bowel-diseases-a-systematic-review
#13
Laura Martelli, Laurent Peyrin-Biroulet
BACKGROUND: Anti-tumor necrosis factor (anti-TNF) monoclonal antibodies have revolutionized the treatment of inflammatory bowel diseases (IBD). However, because of their complexity, their production is expensive contributing to their high price. As the patent protection of these therapies has expired in several countries, biosimilars have been developed to reduce the healthcare costs. The aim of this article is to review the literature on the safety, efficacy and immunogenicity of biosimilars in IBD...
October 14, 2016: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/27747522/emerging-therapies-for-rheumatoid-arthritis
#14
Joachim R Kalden
Diverse strategies to develop novel treatments for rheumatoid arthritis which specifically target those patients who do not respond to available medications, including biologics, are currently being explored. New potential therapeutic approaches which may become available as part of standard therapeutic regimens include the propagation of regulatory T cells and-in the future-of regulatory B cells. New biologic disease-modifying antirheumatic drugs (b-DMARDs) against interleukin-17 and -6, granulocyte-macrophage colony-stimulating factor, and complement component 5 are now standard components of clinical treatment programs...
June 2016: Rheumatol Ther
https://www.readbyqxmd.com/read/27747519/perceptions-and-preferences-of-two-etanercept-autoinjectors-for-rheumatoid-arthritis-a-new-european-union-approved-etanercept-biosimilar-benepali-%C3%A2-versus-etanercept-enbrel-%C3%A2-findings-from-a-nurse-survey-in-europe
#15
Kunal Thakur, Anna Biberger, Alexandra Handrich, Mourad Farouk Rezk
INTRODUCTION: Enbrel(®) (etanercept: manufactured by Immunex Corporation, Newbury Park, Thousand Oaks, CA 91320, USA) was the first biological disease-modifying anti-rheumatic drug approved for the treatment of rheumatoid arthritis (RA) in Europe. More recently, an etanercept biosimilar (Benepali(®): manufactured by Biogen Inc, Cambridge, MA 02124, USA) was approved in the European Union. The perceptions and preferences of the Benepali autoinjector versus Enbrel MYCLIC autoinjector were evaluated by nurses from Europe...
June 2016: Rheumatology and Therapy
https://www.readbyqxmd.com/read/27734233/differentiating-biosimilarity-and-comparability-in-biotherapeutics
#16
Valderilio Azevedo, Brian Hassett, João Eurico Fonseca, Tatsuya Atsumi, Javier Coindreau, Ira Jacobs, Ehab Mahgoub, Julie O'Brien, Ena Singh, Steven Vicik, Brian Fitzpatrick
The manufacture of biologics is a complex process involving numerous steps. Over time, differences may arise as a result of planned changes to the manufacturing processes of a biologic from the same manufacturer. Comparability is the regulatory process that outlines the scope of an assessment required of an already licensed biologic after a manufacturing process change made by the same manufacturer. The aim of a comparability assessment is to demonstrate that any pre-manufacturing and post-manufacturing changes have no adverse impact on quality, safety, and efficacy of the biologic...
October 12, 2016: Clinical Rheumatology
https://www.readbyqxmd.com/read/27733189/what-do-oncologists-need-to-know-about-biosimilar-products
#17
Linda K S Leung, Kevin Mok, Calvin Liu, Stephen L Chan
Many biologic products have improved the outcomes of cancer patients, but the costs can substantially burden healthcare systems. Biosimilar products can potentially reduce drug costs and increase patient access to beneficial treatments. Approval of a biosimilar product relies on the demonstration of "comparability" or "no clinically meaningful differences" as compared to its reference biologic product. Biosimilar products for erythropoietin, granulocyte colony-stimulating factor, trastuzumab, and rituximab are already available, and the regulatory processes in various countries are constantly evolving...
October 13, 2016: Chinese Journal of Cancer
https://www.readbyqxmd.com/read/27729676/biosimilars-are-here-a-hospital-pharmacist-s-guide-to-educating-health-care-professionals-on-biosimilars
#18
EDITORIAL
Steven Jarrett, Theodor Dingermann
BACKGROUND: Pharmacists are the recognized experts in pharmacotherapy. With the recent introduction of biosimilar agents into the US market, pharmacists are poised to play a pivotal role in evaluating their risks versus benefits within the framework of cost containment. PURPOSE: This article provides hospital pharmacists with the necessary information on the principles surrounding the development, approval process, and use of biosimilars. METHODS: Information contained in this article enables hospital pharmacists to identify concerns relating to biosimilars, implement educational components, and successfully evaluate biosimilars for the addition to the formulary...
November 2015: Hospital Pharmacy
https://www.readbyqxmd.com/read/27729659/biosimilars-in-ibd-from-theory-to-practice
#19
REVIEW
Silvio Danese, Stefanos Bonovas, Laurent Peyrin-Biroulet
Biologic agents have revolutionized the care management of many life-threatening and debilitating diseases. As patents for older biologic therapies have begun to expire, the market has opened to copy versions of the originators - commonly referred to as biosimilars, follow-on biologic agents or subsequent-entry biologic agents - which are expected to gain a portion of the market, reduce health-care spending and increase treatment access worldwide. Importantly for patients with IBD, CT-P13 was the first biosimilar to infliximab that obtained regulatory approval by the European Medicines Agency in September 2013 and by the FDA in April 2016...
October 12, 2016: Nature Reviews. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/27723912/-biosimilars-in-oncology-a-therapeutic-alternative-to-the-reference-products
#20
W D Ludwig, S Dicheva
Biosimilar medicinal products (biosimilars) have been available in Europe for 10 years, allowing a wide use particularly in oncology. Biosimilars are being developed and approved by means of scientifically sound principles to assure close similarity with the reference products with regard to quality, efficacy, and safety. The scientific principles for establishing biosimilarity are the same as those for demonstrating comparability after a change in the manufacturing process of an already licensed biological...
October 10, 2016: Zeitschrift Für Gastroenterologie
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