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Biologics/ Biosimilars

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https://www.readbyqxmd.com/read/28095262/biosimilars-in-inflammatory-bowel-disease-accumulating-clinical-evidence
#1
Sean McConachie, Sheila M Wilhelm, Pramodini B Kale-Pradhan
Biologic antagonists to tumor necrosis factor alpha (TNF- α) are effective medications and have become well established in the treatment of both Crohn's disease and ulcerative colitis. Biosimilar medications, which are medications deemed to be equivalent to reference biologic products in terms of clinical effectiveness, safety, pharmacokinetic analysis, and immunogenicity, have now been approved in inflammatory bowel diseases (IBD) based on indication exploration from clinical data in alternate disease states...
January 17, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28092307/the-prosit-bio-cohort-a-prospective-observational-study-of-patients-with-inflammatory-bowel-disease-treated-with-infliximab-biosimilar
#2
Gionata Fiorino, Natalia Manetti, Alessandro Armuzzi, Ambrogio Orlando, Angela Variola, Stefanos Bonovas, Fabrizio Bossa, Giovanni Maconi, Renata DʼIncà, Paolo Lionetti, Laura Cantoro, Walter Fries, Maria L Annunziata, Francesco Costa, Maria M Terpin, Livia Biancone, Claudio C Cortelezzi, Arnaldo Amato, Sandro Ardizzone, Silvio Danese, Luisa Guidi, Giulia Rizzuto, Arianna Massella, Angelo Andriulli, Alessandro Massari, Greta Lorenzon, Silvia Ghione, Anna Kohn, Agostino Ventra, Vito Annese
BACKGROUND: Few data are available on the safety and efficacy of infliximab biosimilar CT-P13 in patients with ulcerative colitis and Crohn's disease. METHODS: A prospective, multicenter, cohort study using a structured database. RESULTS: Consecutive patients (313 Crohn's disease and 234 ulcerative colitis) were enrolled from 31 referral centers; 311 patients were naive to anti-tumor necrosis factor alpha, 139 had a previous exposure to biologics, and the remaining 97 were switched to CT-P13 after a mean of 18 ± 14 infusions of infliximab...
February 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28078656/biosimilars-for-the-treatment-of-cancer-a-systematic-review-of-published-evidence
#3
REVIEW
Ira Jacobs, Reginald Ewesuedo, Sadiq Lula, Charles Zacharchuk
BACKGROUND: Biologic treatments for cancer continue to place a significant economic burden on healthcare stakeholders. Biosimilar therapies may help reduce this burden through cost savings, thereby increasing patient access. OBJECTIVES: The purpose of this study was to collate all published data to assess the weight of available evidence (quantity and quality) for proposed monoclonal antibody biosimilars and intended copies, for the treatment of cancer. METHODS: MEDLINE(®), Embase(®), and ISI Web of Science(®) databases were searched to September 2015...
January 11, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28074074/ibd-in-2016-biologicals-and-biosimilars-in-ibd-the-road-to-personalized-treatment
#4
Krisztina B Gecse, Péter L Lakatos
No abstract text is available yet for this article.
January 11, 2017: Nature Reviews. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28068848/the-safety-of-emerging-biosimilar-drugs-for-the-treatment-of-rheumatoid-arthritis
#5
J Braun, J Kay
Biological disease-modifying anti-rheumatic drugs (bDMARDs), often administered in combination with methotrexate, target specific inflammatory mediators and have transformed the treatment of rheumatic diseases, especially rheumatoid arthritis (RA) but also the spondyloarthritides. However, the high cost of these drugs in many countries restricts patient access. As many bDMARDs have reached or are near to patent expiration, numerous biosimilar drugs are in development and some have already been approved. Biosimilars are generally priced lower than their reference products (RPs), or bio-originators, and as prices come down it is hoped that patient access to these drugs will increase, making the safety of these drugs an area of major interest...
January 10, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28057166/similar-biologics-global-opportunities-and-issues
#6
Prasanta Kumar Ghosh
The invention and use of a large number of biologics during the last three decades for treating various deficiencies and chronic disorders has resulted in great benefit to human health. Abundant use of these biologics has been considerably constrained due to the reasons of their increased prices, charged by the inventors up to the time up to which their use were/are protected by intellectual property rights (IPR).Some of these biologics are presently being manufactured by the existing and newer companies as "similar biologics" after the IPR on these products have expired and as a result the prices of several such medicines are coming down...
October 2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28053335/an-fda-perspective-on-the-assessment-of-proposed-biosimilar-therapeutic-proteins-in-rheumatology
#7
REVIEW
Nikolay P Nikolov, Marjorie A Shapiro
Biologic products have revolutionized the management of many rheumatic diseases, but access to these products might be limited by their relatively high costs. The US Biologics Price Competition and Innovation Act of 2009, which is contained within the Patient Protection and Affordable Care Act, established an abbreviated pathway for licensure by the FDA of biologic products that are demonstrated to be biosimilar to or interchangeable with FDA-licensed biologic products, termed reference products. This law allows for the approval of biosimilar biologic products, which are expected to increase access to treatment for patients, and ensuring the implementation of this Act is a high priority for the FDA...
January 5, 2017: Nature Reviews. Rheumatology
https://www.readbyqxmd.com/read/28035633/infliximab-biosimilars-in-the-treatment-of-inflammatory-bowel-diseases-a-systematic-review
#8
REVIEW
Massimo Radin, Savino Sciascia, Dario Roccatello, Maria Jose Cuadrado
BACKGROUND: Biological therapies represent a fundamental innovation for the management of inflammatory bowel diseases (IBD). However, many biological originators have reached, or are about to reach, patent expiry and long-term therapy costs have become progressively unsustainable. CT-P13, a biosimilar of the anti-tumor necrosis factor (anti-TNF) monoclonal antibody infliximab, might represent a significant alternative to its originator, with the potential to decrease medical care costs and, therefore, become available to a large number of patients...
December 29, 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28035201/the-role-of-biosimilars-in-inflammatory-bowel-disease
#9
Sudarshan Paramsothy, Noa Krugliak Cleveland, Nada Zmeter, David T Rubin
Monoclonal antibody biologic therapies, introduced nearly 20 years ago, revolutionized the treatment of inflammatory bowel disease (IBD) and are now well established as the most effective agents available. As the first of these biologic agents starts to come off patent, biosimilar agents have emerged as alternatives to originator drugs. The unique drug development and manufacturing processes involved in the creation of biologic agents pose distinct regulatory challenges compared to generic formulations of conventional medications...
December 2016: Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28034906/fda-s-approach-to-regulating-biosimilars
#10
Steven J Lemery, M Stacey Ricci, Patricia Keegan, Amy E McKee, Richard Pazdur
The Biosimilar Price Competition and Innovation (BPCI) Act, enacted as part of the Affordable Care Act, created a new licensure pathway for biological products demonstrated to be biosimilar with or interchangeable with an FDA-licensed biological product (the "reference product"). FDA's approach to the regulation of biosimilars is based on the requirements set forth in the BPCI Act. A biosimilar product is highly similar to the reference product notwithstanding minor differences in clinically inactive components and there are no clinically meaningful differences between products in terms of safety, purity, and potency...
December 29, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28026996/on-hybrid-parallel-crossover-designs-for-assessing-drug-interchangeability-of-biosimilar-products
#11
Shein-Chung Chow, Fuyu Song, Can Cui
In recent years, a specific hybrid parallel-crossover design that consists of two sequences of treatments, namely R-R-R-R and R-T-R-T, where T and R is a proposed biosimilar product and an innovative biological product, respectively has been proposed and received much attention for assessing drug interchangeability between T and R, where R could be either an US-licensed product or an EU-reference product. In practice, there are three types of hybrid parallel-crossover designs that are commonly employed in assessing drug interchangeability of biosimilar products...
December 27, 2016: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/28012020/product-safety-spillovers-and-market-viability-for-biologic-drugs
#12
John Romley, Tiffany Shih
When a pharmaceutical manufacturer experiences a safety problem, negative impacts on profitability can spread to its competitors. Reduced consumer confidence, product recalls, and litigation are limited to the responsible manufacturer only if that manufacturer can be clearly linked to the safety problem. We analyze the impact of "accountability" for safety problems on manufacturer entry decisions and investments to mitigate risk. Consistent with prior research, we find investment levels increase with accountability in a duopoly market, and that accountability can thus enhance market viability and improve consumer welfare...
December 23, 2016: Int J Health Econ Manag
https://www.readbyqxmd.com/read/28005456/physicochemical-and-biological-characterization-of-sb2-a-biosimilar-of-remicade%C3%A2-infliximab
#13
Juyong Hong, Yuhwa Lee, Changsoo Lee, Suhyeon Eo, Soyeon Kim, Nayoung Lee, Jongmin Park, Seungkyu Park, Donghyuck Seo, Min Jeong, Youngji Lee, Soojeong Yeon, George Bou-Assaf, Zoran Sosic, Wei Zhang, Orlando Jaquez
A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product. Biosimilarity to the reference product (RP) in terms of quality characteristics, such as physicochemical and biological properties, safety, and efficacy, based on a comprehensive comparability exercise needs to be established. SB2 (Flixabi® and Renflexis®) is a biosimilar to Remicade® (infliximab). The development of SB2 was performed in accordance with relevant guidelines of the International Conference on Harmonisation, the European Medicines Agency, and the United States Food and Drug Administration...
December 22, 2016: MAbs
https://www.readbyqxmd.com/read/28000573/-immunogenicity-of-biosimilars
#14
L A G J M van Aerts, A A M Franken, H G M Leufkens
Biosimilars of more complex recombinant protein drugs, such as monoclonal antibodies and fusion proteins, are entering the market. The manufacturer should demonstrate that its product does not show any relevant differences in terms of quality characteristics, biological activity, safety and efficacy compared to the reference product, as outlined in EMA guidelines. This should be established with an extensive comparability exercise. One aspect that is subject to particular scrutiny is the immunogenicity of the biosimilar and the reference medicinal product...
2016: Nederlands Tijdschrift Voor Geneeskunde
https://www.readbyqxmd.com/read/27990383/biologics-use-in-indian-psoriasis-patients
#15
Murlidhar Rajagopalan, Asit Mital
The biologics currently in use for psoriasis in India are etanercept, infliximab and recently introduced itolizumab and secukinumab. Biosimilars, expected to play a significant role in psoriasis management in future, have also been available for the last few years. Patients with psoriasis may be considered eligible to receive treatment with any of the licensed biologic interventions when they fulfill the eligibility criteria. The decision to proceed with treatment must be made in collaboration with the patient and include a careful assessment of the associated risks and benefits...
November 2016: Indian Dermatology Online Journal
https://www.readbyqxmd.com/read/27977326/development-of-statistical-methods-for-analytical-similarity-assessment
#16
Yi Tsong, Xiaoyu Dong, Meiyu Shen
To evaluate the analytical similarity between the proposed biosimilar product and the US-licensed reference product, a working group at Food and Drug Administration (FDA) developed a tiered approach. This proposed tiered approach starts with a criticality determination of quality attributes (QAs) based on risk ranking of their potential impact on product quality and the clinical outcomes. Those QAs characterize biological products in terms of structural, physico-chemical, and functional properties. Correspondingly, we propose three tiers of statistical approaches based on its levels of stringent in requirements...
December 15, 2016: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/27971687/cost-of-switching-from-an-originator-biologic-remicade-to-a-biosimilar
#17
C N Brown, E McCann
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27970995/market-uptake-models-of-biosimilars-and-off-patent-biological-medicines
#18
E Moorkens, N Meuwissen, I Huys, A Vulto, P Declerck, S Simoens
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27965129/comparative-subcutaneous-repeated-toxicity-study-of-enoxaparin-products-in-rats
#19
Zina Kobbi, Hazar Kraiem, Zakaria Benlasfar, Ammar Marouani, Taieb Massoud, Samir Boubaker, Balkiss Bouhaouala-Zahar, Nadia Fenina
Enoxaparin is a low-molecular-weight heparin widely used for the prevention and treatment of thromboembolism. With the development of several enoxaparin biosimilars, real medical concerns about their safety and efficacy have been raised. This repeated dose toxicity study consists of preclinical toxicological evaluation of a biosimilar biological version of enoxaparin, the drug product "Enoxa", compared to the enoxaparin reference drug product, "Lovenox". Eighty white Wistar rats were treated with "Enoxa" versus the reference product, using subcutaneous therapeutic and toxic doses, varying from 3...
December 10, 2016: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/27960557/the-biologics-of-ulcerative-colitis
#20
Fabio Salvatore Macaluso, Sara Renna, Ambrogio Orlando, Mario Cottone
Tumor necrosis factor α inhibitors dramatically changed the management of moderate-to-severe phenotypes of ulcerative colitis. The recent incoming of vedolizumab, which targets gut-specific leukocyte trafficking, provides a new biologic option for these patients. Areas covered: This review focuses on the rationale of use, efficacy, and safety profile of all biologics currently approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of ulcerative colitis, including tumor necrosis factor α inhibitors (Infliximab and biosimilars, adalimumab, and golimumab), and the more recent vedolizumab...
February 2017: Expert Opinion on Biological Therapy
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