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https://www.readbyqxmd.com/read/28740623/patient-access-to-reimbursed-biological-disease-modifying-antirheumatic-drugs-in-the-european-region
#1
Zoltán Kaló, Zoltán Vokó, Andrew Östör, Emma Clifton-Brown, Radu Vasilescu, Alysia Battersby, Edward Gibson
Background & Objectives: Biological disease-modifying antirheumatic drugs (bDMARDs) for the treatment of rheumatoid arthritis (RA) are not always accessible to all patients in accordance with international guidelines, partly owing to their high direct costs against a background of restricted healthcare budgets. This study compares the size of RA patient populations with access to reimbursed bDMARDs across 37 European countries, Russia, and Turkey, according to their treatment eligibility defined by European League Against Rheumatism (EULAR) recommendations and national reimbursement criteria...
2017: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/28740617/supply-side-and-demand-side-policies-for-biosimilars-an-overview-in-10-european-member-states
#2
Cécile Rémuzat, Anna Kapuśniak, Aleksandra Caban, Dan Ionescu, Guerric Radière, Cyril Mendoza, Mondher Toumi
This study aimed to provide an overview of biosimilar policies in 10 EU MSs. Methods: Ten EU MS pharmaceutical markets (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden, and the UK) were selected. A comprehensive literature review was performed to identify supply-side and demand-side policies in place in the selected countries. Results: Supply-side policies for biosimilars commonly include price linkage, price re-evaluation, and tendering; the use of internal or external reference pricing varies between countries; health technology assessment is conducted in six countries...
2017: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/28740599/biosimilars-imitation-games
#3
EDITORIAL
Hussain Dahodwala, Susan T Sharfstein
Biopharmaceutical sales were at $160 billion in 2016. With many top revenue biopharmaceuticals coming off patent in the next 4 years, there is a tremendous rush by leading biopharmaceutical companies worldwide to launch biosimilar versions of innovator products. However, these protein drugs are extremely difficult to copy. In this viewpoint, we will discuss the various drugs slated to lose patent protection and the challenges in manufacturing these drugs using current technologies. The Food and Drug Administration's regulatory role and definitions of similarity will be discussed, and finally, the scientific challenges in mimicking a protein drug in the current patent- and innovation-driven research field will be considered...
July 13, 2017: ACS Medicinal Chemistry Letters
https://www.readbyqxmd.com/read/28733914/molecular-and-functional-analysis-of-monoclonal-antibodies-in-support-of-biologics-development
#4
REVIEW
Xin Wang, Zhiqiang An, Wenxin Luo, Ningshao Xia, Qinjian Zhao
Monoclonal antibody (mAb)-based therapeutics are playing an increasingly important role in the treatment or prevention of many important diseases such as cancers, autoimmune disorders, and infectious diseases. Multi-domain mAbs are far more complex than small molecule drugs with intrinsic heterogeneities. The critical quality attributes of a given mAb, including structure, post-translational modifications, and functions at biomolecular and cellular levels, need to be defined and profiled in details during the developmental phases of a biologics...
July 21, 2017: Protein & Cell
https://www.readbyqxmd.com/read/28733862/recommendations-for-systematic-statistical-computation-of-immunogenicity-cut-points
#5
Viswanath Devanarayan, Wendell C Smith, Rocco L Brunelle, Mary E Seger, Kim Krug, Ronald R Bowsher
Today, the assessment of immunogenicity is integral in nonclinical and clinical testing of new biotherapeutics and biosimilars. A key component in the risk-based evaluation of immunogenicity involves the detection and characterization of anti-drug antibodies (ADA). Over the past couple of decades, much progress has been made in standardizing the generalized approach for ADA testing with a three-tiered testing paradigm involving screening, confirmation, and quasi-quantitative titer assessment representing the typical harmonized scheme...
July 21, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28728599/a-phase-iii-randomized-two-armed-double-blind-parallel-active-controlled-and-non-inferiority-clinical-trial-to-compare-efficacy-and-safety-of-biosimilar-adalimumab-cinnora%C3%A2-to-the-reference-product-humira%C3%A2-in-patients-with-active-rheumatoid-arthritis
#6
Ahmadreza Jamshidi, Farhad Gharibdoost, Mahdi Vojdanian, Soosan G Soroosh, Mohsen Soroush, Arman Ahmadzadeh, Mohammad Ali Nazarinia, Mohammad Mousavi, Hadi Karimzadeh, Mohammad Reza Shakibi, Zahra Rezaieyazdi, Maryam Sahebari, Asghar Hajiabbasi, Ali Asghar Ebrahimi, Najmeh Mahjourian, Amin Mohammadinejad Rashti
BACKGROUND: This study aimed to compare efficacy and safety of test-adalimumab (CinnoRA®, CinnaGen, Iran) to the innovator product (Humira®, AbbVie, USA) in adult patients with active rheumatoid arthritis (RA). METHODS: In this randomized, double-blind, active-controlled, non-inferiority trial, a total of 136 patients with active RA were randomized to receive 40 mg subcutaneous injections of either CinnoRA® or Humira® every other week, while receiving methotrexate (15 mg/week), folic acid (1 mg/day), and prednisolone (7...
July 20, 2017: Arthritis Research & Therapy
https://www.readbyqxmd.com/read/28727871/biosimilars-in-oncology-in-the-united-states-a-review
#7
Chadi Nabhan, Sandeep Parsad, Anthony R Mato, Bruce A Feinberg
Importance: Biosimilars are biological medicines that contain a highly similar version of the active substance of an already approved biologic reference product. The availability of biosimilars might provide an opportunity to lower health care expenditures as a result of the inherent price competition with their reference product. Understanding how biosimilar cancer drugs are regulated, approved, and paid for, as well as their impact in a value-based care environment, is essential for physicians and other stakeholders in oncology...
July 20, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28722494/cost-efficiency-analyses-for-the-us-of-biosimilar-filgrastim-sndz-reference-filgrastim-pegfilgrastim-and-pegfilgrastim-with-on-body-injector-in-the-prophylaxis-of-chemotherapy-induced-febrile-neutropenia
#8
Ali McBride, Kim Campbell, Mohan Bikkina, Karen MacDonald, Ivo Abraham, Sanjeev Balu
AIMS: Guidelines recommend prophylaxis with granulocyte colony-stimulating factor for chemotherapy-induced (febrile) neutropenia (CIN/FN) based on regimen myelotoxicity and patient-related risk factors. Our aim was to conduct a cost-efficiency analysis for the US of the direct acquisition and administration costs of the recently approved biosimilar filgrastim-sndz (Zarxio® EP2006) with reference filgrastim (Neupogen(®)), pegfilgrastim (Neulasta(®)), and pegfilgrastim injection device (Neulasta Onpro(®); hereafter pegfilgrastim-injector) for CIN/FN prophylaxis...
July 19, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/28722480/efficacy-and-safety-of-biosimilar-sar342434-insulin-lispro-in-adults-with-type-1-diabetes-also-using-insulin-glargine-sorella-1-study
#9
Satish Garg, Karin Wernicke-Panten, Maria Rojeski, Suzanne Pierre, Yvonne Kirchhein, Krystyna Jedynasty
BACKGROUND: SAR342434 is a biosimilar (follow-on) of insulin lispro-Humalog®. This study aimed to show similar efficacy, safety and immunogenicity of SAR342434 (SAR-Lis) versus insulin lispro-Humalog (Ly-Lis) in adult patients with type 1 diabetes (T1DM) treated with multiple daily injections while using basal insulin glargine (Lantus®; GLA100GLA-100). MATERIALS AND METHODS: SORELLA-1 was a randomized, open-label Phase 3 study (NCT02273180). Patients completing the 6-month main study continued on SAR-Lis or Ly-Lis, as randomized, for a 6-month safety extension...
July 19, 2017: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/28721016/a-review-of-the-literature-analyzing-benefits-and-concerns-of-infliximab-biosimilar-ct-p13-for-the-treatment-of-rheumatologic-diseases-focus-on-interchangeability
#10
REVIEW
Andrea Becciolini, Maria Gabriella Raimondo, Chiara Crotti, Elena Agape, Martina Biggioggero, Ennio Giulio Favalli
The introduction of biological agents drastically changed the treatment paradigm of inflammatory arthritides, ameliorating the natural history of the diseases but concomitantly increasing the drug costs due to the manufacturing process. On this concern, biosimilar drugs may represent a valid option for reducing this elevated cost and increasing the availability of these highly effective treatments. Recently, CT-P13, the first biosimilar of infliximab, has been approved with the same indications established for the reference product (RP), and its daily use is progressively increasing...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28719221/biosimilars-biologics-that-meet-patients-needs-and-healthcare-economics
#11
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
#12
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
#13
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
#14
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/28712940/efficacy-pharmacokinetics-and-safety-of-the-biosimilar-ct-p10-compared-with-rituximab-in-patients-with-previously-untreated-advanced-stage-follicular-lymphoma-a-randomised-double-blind-parallel-group-non-inferiority-phase-3-trial
#15
Won Seog Kim, Christian Buske, Michinori Ogura, Wojciech Jurczak, Juan-Manuel Sancho, Edvard Zhavrid, Jin Seok Kim, José-Ángel Hernández-Rivas, Aliaksandr Prokharau, Mariana Vasilica, Rajinish Nagarkar, Dzhelil Osmanov, Larry W Kwak, Sang Joon Lee, Sung Young Lee, Yun Ju Bae, Bertrand Coiffier
BACKGROUND: Studies in patients with rheumatoid arthritis have shown that the rituximab biosimilar CT-P10 (Celltrion, Incheon, South Korea) has equivalent efficacy and pharmacokinetics to rituximab. In this phase 3 study, we aimed to assess the non-inferior efficacy and pharmacokinetic equivalence of CT-P10 compared with rituximab, when used in combination with cyclophosphamide, vincristine, and prednisone (CVP) in patients with newly diagnosed advanced-stage follicular lymphoma. METHODS: In this ongoing, randomised, double-blind, parallel-group, active-controlled study, patients aged 18 years or older with Ann Arbor stage III-IV follicular lymphoma were assigned 1:1 to CVP plus intravenous infusions of 375 mg/m(2) CT-P10 or rituximab on day 1 of eight 21-day cycles...
July 13, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28712939/rituximab-biosimilars-introduction-into-clinical-practice
#16
Shinichi Makita, Kensei Tobinai
No abstract text is available yet for this article.
July 13, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28707621/characterization-of-low-molecular-weight-heparins-by-strong-anion-exchange-chromatography
#17
Radosław Sadowski, Renata Gadzała-Kopciuch, Tomasz Kowalkowski, Paweł Widomski, Ludwik Jujeczka, Bogusław Buszewski
Currently, detailed structural characterization of low-molecular-weight heparin (LMWH) products is an analytical subject of great interest. In this work, we carried out a comprehensive structural analysis of LMWHs and applied a modified pharmacopeial method, as well as methods developed by other researchers, to the analysis of novel biosimilar LMWH products; and, for the first time, compared the qualitative and quantitative composition of commercially available drugs (enoxaparin, nadroparin, and dalteparin)...
July 13, 2017: Journal of AOAC International
https://www.readbyqxmd.com/read/28702519/bottom-up-hydrogen-deuterium-exchange-mass-spectrometry-data-analysis-and-interpretation
#18
Kerene A Brown, Derek J Wilson
Hydrogen Deuterium Exchange (HDX) Mass Spectrometry (MS) is a sensitive analytical technique that provides information on protein conformation and dynamics in solution. It is commonly used in the study of protein-ligand and protein-protein interactions and more recently in the pharmaceutical industry for epitope mapping, screening drug candidates and in the comparison of biopharmaceuticals to biosimilars. HDX-MS monitors the exchange of protein backbone hydrogen atoms with deuterium in solution. Recent advancements in HDX automation and data analysis, have taken the emphasis off developing a fundamental understanding of HDX, which is still lacking...
July 13, 2017: Analyst
https://www.readbyqxmd.com/read/28692448/the-use-of-biosimilars-in-paediatric-inflammatory-bowel-disease
#19
Maria Myrthe Elisabeth Jongsma, Arnold Vulto, Lissy de Ridder
PURPOSE OF REVIEW: After expiry of the patent of originator anti-tumor necrosis factor drug infliximab (Remicade), CT-P13 was in 2013 the first infliximab biosimilar to be approved by the European Medicine Agency (EMA) for the same indications as the reference drug, including paediatric inflammatory bowel disease (IBD). The approval was based on extrapolation, after extensive in-vitro studies and clinical experience in patients with ankylosing spondylitis and rheumatoid arthritis. The extrapolation of CT-P13 to IBD and to paediatric patients raised concerns among paediatric IBD specialists...
July 7, 2017: Current Opinion in Pediatrics
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
#20
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
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