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Biologics/ Biosimilars

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https://www.readbyqxmd.com/read/28719221/biosimilars-biologics-that-meet-patients-needs-and-healthcare-economics
#1
Mark McCamish, William Yoon, James McKay
Biologics have revolutionized medical care, yet uniform access to these effective medicines remains difficult due to the increasing costs of healthcare. As patent exclusivity on the early biologics wanes, regulatory and legal systems are adapting to bring competition to the field in the form of biosimilars. Biosimilars are biologics that offer the same clinical benefit in one or more of the same indications as the reference biologic drug and bring competition to the biologics space. Legislation creating a pathway resulting in the first US approvals of biosimilars has been in place since 2010, but the regulatory methodology and science of evaluating the sameness of two biologics has been in use for decades...
September 2016: American Journal of Managed Care
https://www.readbyqxmd.com/read/28718062/update-on-biosimilars-in-asia
#2
REVIEW
Wen-Chan Tsai
PURPOSE OF REVIEW: This review provides an update on the evolution of, manufacturing of, and regulations for biosimilars in Asian countries. RECENT FINDINGS: The use of biologics revolutionized the treatment of various diseases. However, the high cost of biologics remained unaffordable for most Asian patients and increases the financial burden of Asian governments. The development of biosimilars provides the best solution for this predicament. A great boom of biosimilars is developing in Asia...
August 2017: Current Rheumatology Reports
https://www.readbyqxmd.com/read/28715605/how-to-select-a-nanosimilar
#3
Alain Astier, Amy Barton Pai, Marco Bissig, Daan J A Crommelin, Beat Flühmann, Jean-Daniel Hecq, Josefien Knoeff, Hans-Peter Lipp, Alberto Morell-Baladrón, Stefan Mühlebach
Nanomedicines in the class of nonbiological complex drugs (NBCDs) are becoming increasingly available. Up to 23 nanomedicines have been approved, and approximately 50 are in clinical development. Meanwhile, the first nanosimilars have entered the market through the generic approval pathway, but clinical differences have been observed. Many healthcare professionals may be unaware of this issue and must be informed of these clinically relevant variances. This article provides a tool for rational decision making for the inclusion of nanomedicines into the hospital formulary, including defined criteria for evaluation of substitutability or interchangeability...
July 17, 2017: Annals of the New York Academy of Sciences
https://www.readbyqxmd.com/read/28712941/rituximab-biosimilar-and-reference-rituximab-in-patients-with-previously-untreated-advanced-follicular-lymphoma-assist-fl-primary-results-from-a-confirmatory-phase-3-double-blind-randomised-controlled-study
#4
Wojciech Jurczak, Ilídia Moreira, Govind Babu Kanakasetty, Eduardo Munhoz, Maria Asunción Echeveste, Pratyush Giri, Nelson Castro, Juliana Pereira, Luiza Akria, Sergey Alexeev, Eugeniy Osmanov, Peijuan Zhu, Siyka Alexandrova, Angela Zubel, Olof Harlin, Jutta Amersdorffer
BACKGROUND: GP2013 is a rituximab biosimilar developed to stringent development guidelines, including non-clinical and preclinical investigations and clinical trials in rheumatoid arthritis and follicular lymphoma. We aimed to compare the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of GP2013 plus cyclophosphamide, vincristine, and prednisone (GP2013-CVP) with rituximab-CVP (R-CVP) in patients with follicular lymphoma. METHODS: In this phase 3, multinational, double-blind, randomised, controlled trial, adults (aged 18 years or older) with previously untreated, advanced stage (Ann Arbor stage III or IV) follicular lymphoma of WHO histological grades 1, 2, or 3a were randomly assigned (1:1) using interactive response technology to eight cycles of GP2013-CVP or R-CVP (combination phase), followed by monotherapy maintenance in responders for a 2-year period...
July 13, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28689708/the-growing-role-of-biologics-and-biosimilars-in-the-united-states-perspectives-from-the-apha-biologics-and-biosimilars-stakeholder-conference
#5
Judy Crespi-Lofton, Jann B Skelton
OBJECTIVES: The American Pharmacists Association (APhA) convened the Biologics and Biosimilars Stakeholder Conference on November 30, 2016, in Washington DC. The objectives of the Conference were to determine the key issues and challenges within the marketplace for biologics, follow-on biologics (FOBs), and biosimilars, identify potential roles and responsibilities of pharmacists regarding biologic and biosimilar medications, and identify actions or activities that pharmacists may take to optimize the safe and cost-effective use of biologics and biosimilars...
July 6, 2017: Journal of the American Pharmacists Association: JAPhA
https://www.readbyqxmd.com/read/28686780/a-survey-assessment-of-us-dermatologists-perception-of-biosimilars
#6
Alexandra Barsell, Monica Rengifo-Pardo, Alison Ehrlich
<p>BACKGROUND: Biologics have transformed the treatment of psoriasis and psoriatic arthritis, but at a significant cost to payers and patients. The introduction of biosimilars into the US market could reduce costs while increasing access to biologic medications.</p> <p>OBJECTIVE: We sought to identify gaps in biosimilar knowledge and perception among US dermatologists.</p> <p>METHODS: An online survey was sent to dermatologists from January to April 2015.</p> <p>RESULTS: Ninety-seven US dermatologists responded, of which 84% state they prescribe biologics in their practice...
June 1, 2017: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/28666961/assessing-awareness-and-attitudes-of-healthcare-professionals-on-the-use-of-biosimilar-medicines-a-survey-of-physicians-and-pharmacists-in-ireland
#7
Joan O'Callaghan, Margaret Bermingham, Maurice Leonard, Frank Hallinan, J Michael Morris, Una Moore, Brendan T Griffin
Increasing numbers of biosimilar medicines are becoming available. The objective of this survey was to assess awareness of and attitudes to biosimilars amongst physicians (medical specialists and General Practitioners (GPs)) and community pharmacists in Ireland. Physicians were invited to complete an online questionnaire during April and May 2016. Community pharmacists received a postal questionnaire in August 2015. Responses from 102 medical specialists, 253 GPs and 125 community pharmacists were analysed...
June 27, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28660473/assessing-the-value-of-biosimilars-a-review-of-the-role-of-budget-impact-analysis
#8
REVIEW
Steven Simoens, Ira Jacobs, Robert Popovian, Leah Isakov, Lesley G Shane
Biosimilar drugs are highly similar to an originator (reference) biologic, with no clinically meaningful differences in terms of safety or efficacy. As biosimilars offer the potential for lower acquisition costs versus the originator biologic, evaluating the economic implications of the introduction of biosimilars is of interest. Budget impact analysis (BIA) is a commonly used methodology. This review of published BIAs of biosimilar fusion proteins and/or monoclonal antibodies identified 12 unique publications (three full papers and nine congress posters)...
June 28, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/28652703/ct-p13-design-development-and-place-in-therapy
#9
REVIEW
Tommaso Gabbani, Simona Deiana, Vito Annese
The introduction of biological agents has revolutionized the management of many life-threatening and debilitating immune-mediated diseases. Because of the high cost of biological drugs and their patent expiration, the market has opened to biosimilar agents, copy versions of the originators, which can lead to reduced health care expenditure and increase treatment access worldwide. CT-P13 is the first biosimilar of infliximab (IFX) and has been approved for the same indications as its originator drug. It obtained regulatory approval by the European Medicines Agency in September 2013 and by the US Food and Drug Administration in April 2016...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28650704/is-there-a-reason-for-concern-or-is-it-just-hype-a-systematic-literature-review-of-the-clinical-consequences-of-switching-from-originator-biologics-to-biosimilars
#10
András Inotai, Christiaan P J Prins, Marcell Csanádi, Dinko Vitezic, Catalin Codreanu, Zoltán Kaló
While prescribing biosimilars to patients naive to a biologic treatment is a well-accepted practice, switching clinically stable patients from an originator to a biosimilar is an issue for clinicians. Well-designed clinical trials and real-world data which study the consequences of switching from an originator biologic treatment to its biosimilar alternative are limited, especially for monoclonal antibodies. Areas covered: A systematic literature review was conducted on PubMed to identify evidence of the consequences of switching from original biologics to biosimilars...
June 26, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28646580/biosimilars-for-psoriasis-worldwide-overview-of-regulatory-guidelines-uptake-and-implications-for-dermatology-clinical-practice
#11
REVIEW
A D Cohen, J J Wu, L Puig, S Chimenti, R Vender, M Rajagopalan, R Romiti, C de la Cruz, L Skov, C Zachariae, H S Young, P Foley, J M van der Walt, L Naldi, A Blauvelt
The introduction of biologic drugs for the treatment of patients with psoriasis has revolutionized treatment paradigms and enabled numerous patients to achieve disease control with an acceptable safety profile. However, the high cost of biologics limits access to these medications for the majority of patients worldwide. In recent years, the introduction of biosimilars for inflammatory diseases has become a fast evolving field. The future use of biosimilars offers the potential for decreased cost and increased access to biologic drugs for patients with psoriasis...
June 24, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/28642700/pricing-and-reimbursement-of-biosimilars-in-central-and-eastern-european-countries
#12
Paweł Kawalec, Ewa Stawowczyk, Tomas Tesar, Jana Skoupa, Adina Turcu-Stiolica, Maria Dimitrova, Guenka I Petrova, Zinta Rugaja, Agnes Männik, Andras Harsanyi, Pero Draganic
Objectives: The aim of this study was to review the requirements for the reimbursement of biosimilars and to compare the reimbursement status, market share, and reimbursement costs of biosimilars in selected Central and Eastern European (CEE) countries. Methods: A questionnaire-based survey was conducted between November 2016 and January 2017 among experts from the following CEE countries: Bulgaria, Czech Republic, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. The requirements for the pricing and reimbursement of biosimilars were reviewed for each country...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28640663/glycosylation-profile-and-biological-activity-of-remicade%C3%A2-compared-with-flixabi%C3%A2-and-remsima%C3%A2
#13
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/28637743/knowledge-attitude-and-practice-of-healthcare-professionals-towards-infliximab-and-insulin-glargine-biosimilars-result-of-a-uk-web-based-survey
#14
Stephen R Chapman, Raymond W Fitzpatrick, Mohammed I Aladul
OBJECTIVE: To investigate healthcare professionals' knowledge and attitudes towards infliximab and insulin glargine biosimilars and the factors influencing their prescribing. Then, to compare healthcare professionals' attitudes with the utilisation of these biosimilars in UK hospitals. DESIGN: Self-administered, one-time web-based survey and drug utilisation analysis. SETTING AND DATA SOURCES: Professional associations and societies in the field of dermatology, diabetology, gastroenterology and rheumatology in the UK, between 8 August 2016 and 8 January 2017...
June 21, 2017: BMJ Open
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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