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Biologics/ Biosimilars

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https://www.readbyqxmd.com/read/28640663/glycosylation-profile-and-biological-activity-of-remicade%C3%A2-compared-with-flixabi%C3%A2-and-remsima%C3%A2
#1
Changsoo Lee, Min Jeong, JongAh Joanne Lee, Saebom Seo, Sung Chun Cho, Wei Zhang, Orlando Jaquez
As biosimilars enter the market, comparisons of product quality are needed. Manufacturing differences may lead to differences in critical quality attributes, which affect efficacy. Therefore, critical quality attributes (structure and biological activity) of Remicade® and of 2 biosimilar products (Flixabi®/Renflexis® and Remsima®/Inflectra®) were determined. We assessed binding to tumor necrosis factor in a fluorescence competitive binding assay; potency in a luciferase reporter gene assay; percentages of galactosylated glycan, afucose plus high mannosylated glycans, and charged glycan; FcγRIIIa (CD16) binding (assessed by 3 methods); and antibody-dependent cell-mediated cytotoxicity (ADCC) in the NK92-CD16a cell line and in peripheral blood mononuclear cells (PBMC)...
June 22, 2017: MAbs
https://www.readbyqxmd.com/read/28623625/switching-between-reference-biologics-and-biosimilars-for-the-treatment-of-rheumatology-gastroenterology-and-dermatology-inflammatory-conditions-considerations-for-the-clinician
#2
REVIEW
Robert Moots, Valderilio Azevedo, Javier L Coindreau, Thomas Dörner, Ehab Mahgoub, Eduardo Mysler, Morton Scheinberg, Lisa Marshall
PURPOSE OF REVIEW: Biosimilars of the reference biologic therapeutics infliximab, etanercept, adalimumab, and rituximab are entering the market. Clinical and real-world data on the effects of reference → biosimilar switching are limited. This review was carried out to assess the current body of switching data. RECENT FINDINGS: Fifty-three switching studies were identified. Infliximab publications covered CT-P13 (25 studies), SB2 (1), infliximab NK (1), and unspecified infliximab biosimilars (2)...
June 2017: Current Rheumatology Reports
https://www.readbyqxmd.com/read/28620302/adoption-of-biosimilar-infliximab-for-rheumatoid-arthritis-ankylosing-spondylitis-and-inflammatory-bowel-diseases-in-the-eu5-a-budget-impact-analysis-using-a-delphi-panel
#3
Tim A Kanters, Jelena Stevanovic, Isabelle Huys, Arnold G Vulto, Steven Simoens
Introduction: Introducing biosimilar infliximab for the treatment in rheumatology (rheumatoid arthritis and ankylosing spondylitis) and inflammatory bowel disease (Crohn's disease and ulcerative colitis) may reduce treatment costs associated with biologics. This study aimed to investigate the budget impact of adopting biosimilar infliximab in five European countries, considering that the budget impact includes the adoption of biosimilar infliximab and the availability of biologic alternatives such as vedolizumab, biosimilar etanercept, biosimilar rituximab, and other relevant factors...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28619479/a-demonstration-of-analytical-similarity-comparing-a-proposed-biosimilar-pegfilgrastim-and-reference-pegfilgrastim
#4
Stephen Brokx, Louise Scrocchi, Nirmesh Shah, Jason Dowd
BACKGROUND: Recombinant human granulocyte-colony stimulating factor (G-CSF, filgrastim) is used primarily to reduce incidence and duration of severe neutropenia and its associated complications in cancer patients that have received a chemotherapy regimen. The pegylated form of filgrastim, "pegfilgrastim", is a long-acting form that requires only a once-per-cycle administration for the management of chemotherapy-induced neutropenia. Apobiologix, a division of ApoPharma USA, Inc., and Intas Pharmaceuticals Limited have co-developed a proposed pegfilgrastim biosimilar to US-licensed pegfilgrastim...
June 12, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28615973/can-biosimilars-help-achieve-the-goals-of-us-health-care-reform
#5
REVIEW
Ralph Boccia, Ira Jacobs, Robert Popovian, Gilberto de Lima Lopes
The US Patient Protection and Affordable Care Act (ACA) aims to expand health care coverage, contain costs, and improve health care quality. Accessibility and affordability of innovative biopharmaceuticals are important to the success of the ACA. As it is substantially more difficult to manufacture them compared with small-molecule drugs, many of which have generic alternatives, biologics may increase drug costs. However, biologics offer demonstrated improvements in patient care that can reduce expensive interventions, thus lowering net health care costs...
2017: Cancer Management and Research
https://www.readbyqxmd.com/read/28612180/immunogenicity-of-biologics-in-chronic-inflammatory-diseases-a-systematic-review
#6
REVIEW
Vibeke Strand, Alejandro Balsa, Jamal Al-Saleh, Leonor Barile-Fabris, Takahiko Horiuchi, Tsutomu Takeuchi, Sadiq Lula, Charles Hawes, Blerina Kola, Lisa Marshall
OBJECTIVES: A systematic review was conducted to explore the immunogenicity of biologic agents across inflammatory diseases and its potential impact on efficacy/safety. METHODS: Literature searches were conducted through November 2016 to identify controlled and observational studies of biologics/biosimilars administered for treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), psoriasis (Ps), Crohn's disease, and ulcerative colitis...
June 13, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28612179/efficacy-safety-and-pharmacokinetics-of-up-to-two-courses-of-the-rituximab-biosimilar-ct-p10-versus-innovator-rituximab-in-patients-with-rheumatoid-arthritis-results-up-to-week-72-of-a-phase-i-randomized-controlled-trial
#7
Dae Hyun Yoo, Chang-Hee Suh, Seung Cheol Shim, Slawomir Jeka, Francisco Fidencio Cons Molina, Pawel Hrycaj, Piotr Wiland, Eun Young Lee, Francisco G Medina-Rodriguez, Pavel Shesternya, Sebastiao Radominski, Marina Stanislav, Volodymyr Kovalenko, Dong Hyuk Sheen, Leysan Myasoutova, Mie Jin Lim, Jung-Yoon Choe, Sang Joon Lee, Sung Young Lee, Sung Hwan Kim, Won Park
BACKGROUND: CT-P10 is a biosimilar of innovator rituximab (RTX), a biological therapy used to treat patients with rheumatoid arthritis (RA) who have responded inadequately to anti-tumor necrosis factor agents. OBJECTIVE: Our objective was to compare the clinical profile of CT-P10 versus RTX in patients with RA who received up to two courses of treatment and were followed for up to 72 weeks. METHODS: In this multicenter double-blind phase I study, patients were randomized 2:1 to receive CT-P10 1000 mg or RTX 1000 mg at weeks 0 and 2...
June 13, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28612093/clinical-trial-design-in-juvenile-idiopathic-arthritis
#8
Stephen J Balevic, Mara L Becker, Michael Cohen-Wolkowiez, Laura E Schanberg
Randomized clinical trials provide the gold standard evidence base to guide clinical practice. Despite major advances in trial design, pediatric clinical trials are still difficult to perform and pose unique challenges, including the need to consider the impact of developmental changes in trial design. Advances within pediatric rheumatology combined with the need to comply with legislative requirements have driven new approaches to performing pediatric clinical trials such as utilization of large research networks, incorporation of patient and family stakeholders in the planning and implementation of clinical trials, and the development of novel trial designs...
June 13, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28608570/introduction-of-similar-insulins-in-europe
#9
REVIEW
M Davies, D Dahl, T Heise, J Kiljanski, C Mathieu
Regulatory approval of the first biosimilar insulin in Europe, LY2963016 insulin glargine (Abasaglar(®) ), in 2014 expanded the treatment options available to people with diabetes. As biosimilar insulin products come to market, it is important to recognize that insulin products are biologicals manufactured through complex biotechnology processes, and thus biosimilar insulins cannot be considered identical to their reference products. Strict regulatory guidelines adopted by authorities in Europe, the USA and some other countries help to ensure that efficacy and safety profiles of biosimilar insulins are not meaningfully different from those of the reference products, preventing entry of biological compounds not meeting quality standards and potentially affecting people's glycaemic outcomes...
June 13, 2017: Diabetic Medicine: a Journal of the British Diabetic Association
https://www.readbyqxmd.com/read/28607755/access-and-barriers-to-ms-care-in-latin-america
#10
REVIEW
Víctor M Rivera, Miguel Angel Macias
Multiple sclerosis (MS), an epidemiologically emergent disorder in Latin America (LATAM), poses substantial socioeconomic challenges to a region where most countries remain as economies in development. MS is not health priority despite its economic and communitarian impact with a relatively low prevalence. MS treatments in LATAM have evolved from earlier long-term oral steroids and immunosuppression protocols, to platform disease modifying therapies (DMTs), to the current landscape with more advanced therapeutic molecules...
January 2017: Multiple Sclerosis Journal—Experimental, Translational and Clinical
https://www.readbyqxmd.com/read/28571501/ct-p13-in-the-treatment-of-rheumatoid-arthritis
#11
Dae Hyun Yoo
The first biosimilar infliximab, CT-P13 infliximab-dyyb was approved in 2013 by the European Medicines Agency (EMA) and in 2016 by the United States Food and Drug Administration (FDA) and has been used for the treatment of rheumatoid arthritis (RA) for 4 years. Areas covered: CT-P13 with the three brand names on the market has highly similar efficacy and safety profiles but lower price than originator infliximab and are approved in more than 80 countries. One of the most important determinants of the implementation of CT-P13 in the treatment of RA is scientific evidence from clinical studies and real-world pharmacovigilance data...
July 2017: Expert Review of Clinical Immunology
https://www.readbyqxmd.com/read/28556906/a-dissimilar-biosimilar-lichenoid-drug-eruption-induced-by-an-infliximab-biosimilar
#12
N Gonzalez, P Patel, G Han
The advent of therapeutic antibodies, or biologic medications, has transformed our treatment of many inflammatory diseases in dermatology. Recently, the development of biosimilars, biologic drugs that are highly similar in quality, safety, and efficacy to approved biologics, has changed this landscape. Although biosimilars are not identical to their reference product, they are required to have the same mechanism of action, route of administration, dosage form, and strength as the reference product. This also leads to the possibility that subtle differences in the activity of these biosimilars can lead to differing clinical responses...
May 30, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/28553082/ten-years-of-biosimilars-in-europe-development-and-evolution-of-the-regulatory-pathways
#13
REVIEW
Martin Schiestl, Markus Zabransky, Fritz Sörgel
A biosimilar is defined by the European Medicines Agency as a biological medicine that is similar to another biological medicine that has already been authorized for use. A science-based regulatory framework to ensure high-quality biosimilars has been established in Europe since 2005 and is monitored and updated on an ongoing basis. The guiding principle of a biosimilar development program is to establish similarity between the biosimilar and the reference medicine by the best possible means, ensuring that the previously proven safety and efficacy of the reference medicinal product also applies to the biosimilar...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28553081/ten-years-of-biosimilar-recombinant-human-growth-hormone-in-europe
#14
REVIEW
Paul Saenger
Recombinant human growth hormone (rhGH) has been in clinical use for more than 30 years. With the expiration of patent exclusivity for the first wave of rhGH products and other biopharmaceuticals, the opportunity emerged for the development of biosimilar medicines. A biosimilar is defined by the European Medicines Agency (EMA) as a biological medicine that is similar to another biological medicine that has already been authorized for use. The EMA led the way (well ahead of the Food and Drug Administration in the US) in developing the biosimilar concept, and the type of science-based regulatory framework required to ensure high-quality, safe, and effective biosimilar medicines; the provisions for approval of biosimilars have been in place in Europe since 2005...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28551775/lbec0101-a-proposed-etanercept-biosimilar-pharmacokinetics-immunogenicity-and-tolerability-profiles-compared-with-a-reference-biologic-product-in-healthy-male-subjects
#15
Heechan Lee, Hyewon Chung, SeungHwan Lee, Howard Lee, Sung Mo Yang, Seo Hyun Yoon, Joo-Youn Cho, In-Jin Jang, Kyung-Sang Yu
OBJECTIVES: We performed this study to compare the pharmacokinetic (PK), immunogenicity, and tolerability profiles of etanercept between LBEC0101, a proposed biosimilar, and Enbrel(®), the reference biological product. METHODS: A randomized, double-blind, single-dose, two-treatment, two-period, two-sequence, crossover study was conducted in 48 healthy males. In each period, a single dose of LBEC0101 or Enbrel(®) was subcutaneously injected at 25 mg and serial blood samples for PK evaluation were collected up to 648 h post-dose...
May 27, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28550830/-biologicals-and-biosimilars-gaps-in-the-pharmacovigilance-system-in-portugal
#16
Maria Conceição Portela, Carlos Sinogas, Fernando Albuquerque Almeida, Ricardo Baptista-Leite, Alexandre Castro-Caldas
INTRODUCTION: Biological and biosimilar medicinal products have specific characteristics that call for a closer monitoring of their safety profile. Since the current legal framework stems from both European and national regulations, some gaps in the operational field may be expected. The goal of this paper is to identify these gaps and propose changes to the current information systems and pharmacovigilance regulations. MATERIAL AND METHODS: A qualitative analysis of current pharmacovigilance regulatory framework and supporting information system was conducted...
March 31, 2017: Acta Médica Portuguesa
https://www.readbyqxmd.com/read/28546231/the-brave-new-world-of-biosimilars-similar-biologics-in-india
#17
EDITORIAL
Ramesh Jois
No abstract text is available yet for this article.
May 25, 2017: Postgraduate Medical Journal
https://www.readbyqxmd.com/read/28542043/induction-therapy-with-biosimilar-infliximab-in-children-with-crohn-s-disease
#18
Joanna Sieczkowska-Golub, Monika Meglicka, Anna Plocek, Aleksandra Banaszkiewicz, Dorota Jarzębicka, Ewa Toporowska-Kowalska, Agnieszka Gawronska, Grzegorz Oracz, Jaroslaw Kierkus
INTRODUCTION: In most European countries, an infliximab biosimilar (CT-P13) is currently in common use. In vitro and in vivo studies have proved a high similarity between CT-P13 and the reference infliximab. CT-P13 was licensed for use in patients with Crohn's diseases (CD) based on the extrapolation of data from preclinical studies and clinical trials in rheumatology indications. The aim of this study was to assess the similarity between CT-P13 and the originator infliximab in induction therapy in CD paediatric patients...
May 24, 2017: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/28540760/biologicals-and-biosimilars-safety-issues-in-europe
#19
Maria da Conceição Constantino Portela, Carlos Sinogas, Fernando Albuquerque de Almeida, Ricardo Baptista-Leite, Alexandre Castro-Caldas
Medicinal products of a biological origin are approved by the EMA at a centralized level. However, there is no harmonization about their use in Europe. The current regulation referring to the safety of biological medicinal products and biosimilars in Europe has been identified. The safety associated with medicinal products of a biological origin is assured by the pharmacovigilance system, which has evolved, but doesn't yet incorporate all of the specific information from this market segment, namely that related to the identification of drugs, and its use - including the prescription and dispensing, given the possibility of interchangeability and substitution...
July 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28526943/a-global-reference-comparator-for-biosimilar-development
#20
Christopher J Webster, Gillian R Woollett
Major drug regulators have indicated in guidance their flexibility to accept some development data for biosimilars generated with reference product versions licensed outside their own jurisdictions, but most authorities require new bridging studies between these versions and the versions of them licensed locally. The costs of these studies are not trivial in absolute terms and, due to the multiplier effect of required repetition by each biosimilar sponsor, their collective costs are substantial. Yet versions of biologics licensed in different jurisdictions usually share the same development data, and any manufacturing changes between versions have been justified by a rigorous comparability process...
May 19, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
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