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biosimilar low-molecular-weight heparins

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https://www.readbyqxmd.com/read/27709905/complete-molecular-weight-profiling-of-low-molecular-weight-heparins-using-size-exclusion-chromatography-ion-suppressor-high-resolution-mass-spectrometry
#1
Joseph Zaia, Kshitij Khatri, Joshua Klein, Chun Shao, Yuewei Sheng, Rosa Viner
Low-molecular weight heparins (LMWH) prepared by partial depolymerization of unfractionated heparin are used globally to treat coagulation disorders on an outpatient basis. Patent protection for several LMWH has expired and abbreviated new drug applications have been approved by the Food and Drug Administration. As a result, reverse engineering of LMWH for biosimilar LMWH has become an active global endeavor. Traditionally, the molecular weight distributions of LMWH preparations have been determined using size exclusion chromatography (SEC) with optical detection...
November 1, 2016: Analytical Chemistry
https://www.readbyqxmd.com/read/27017700/-good-planning-practice-in-preclinical-and-clinical-studies-of-unfractionated-and-fractionated-heparins-in-russia-as-the-basis-of-safe-and-effective-anticoagulation-therapy
#2
REVIEW
E V Gavrishina, A V Dobrovolskii, R R Niyazov, D P Romodanovskii, A N Vasil'ev
General principles of appropriate strategies for preclinical and clinical development of unfractionated and low-molecular-weight heparins and demonstration of their biosimilarity to corresponding reference medicinal products are provided. Demonstration of the biosimilarity of heparin-containing medicinal products constitutes the basis for their efficacy and safety during anticoagulation therapy. The main quality, safety, and efficacy characteristics of heparin products are described and the extent of non-clinical and clinical investigations necessary prior to drug marketing authorization are considered...
2015: Eksperimental'naia i Klinicheskaia Farmakologiia
https://www.readbyqxmd.com/read/24816308/low-molecular-weight-heparin-biosimilars-potential-implications-for-clinical-practice-australian-low-molecular-weight-heparin-biosimilar-working-group-albw
#3
H Nandurkar, B Chong, H Salem, A Gallus, V Ferro, R McKinnon
A working group of clinicians and scientists was formed to review the clinical considerations for use of low-molecular-weight heparin (LMWH) biosimilars. LMWH are biological molecules of significant complexity; the full complexity of chemical structure is still to be elucidated. LMWH biosimilars are products that are biologically similar to their reference product and rely on clinical data from a reference product to establish safety and efficacy. The complex nature of LMWH molecules means that it is uncertain whether a LMWH biosimilar is chemically identical to its reference product; this introduces the possibility of differences in activity and immunogenicity...
May 2014: Internal Medicine Journal
https://www.readbyqxmd.com/read/24561026/isolation-of-a-pure-octadecasaccharide-with-antithrombin-activity-from-an-ultra-low-molecular-weight-heparin
#4
Pierre A J Mourier, Olivier Y Guichard, Frédéric Herman, Christian Viskov
Heparin and low-molecular-weight heparins (LMWHs) are anticoagulant drugs that mainly inhibit the coagulation cascade by indirectly interacting with factor Xa and factor IIa (thrombin). Inhibition of factor Xa by antithrombin (AT) requires the activation of AT by specific pentasaccharide sequences containing 3-O-sulfated glucosamine. Activated AT also inhibits thrombin by forming a stable ternary complex of AT, thrombin, and a polysaccharide (requires at least an 18-mer/octadeca-mer polysaccharide). The full structure of any naturally occurring octadecasaccharide sequence has yet to be determined...
May 15, 2014: Analytical Biochemistry
https://www.readbyqxmd.com/read/24505840/the-comparability-conundrum-biosimilars-in-the-united-states-europe-and-canada
#5
Noel Courage, Ainslie Parsons
A biosimilar contains an active ingredient that is similar, but not identical, to the active ingredient in an approved reference drug. This raises the issue of when and how a biosimilar should be allowed to compare to a reference drug for marketing approval. This paper looks at the current regulation of biosimilars in Europe, the United States and Canada. The response to the challenge of regulating biosimilars has been varied. For example, Europe implemented a specialized, abbreviated legal pathway about five years before the United States...
2011: Food and Drug Law Journal
https://www.readbyqxmd.com/read/23615078/update-of-the-recommendations-on-biosimilar-low-molecular-weight-heparins-from-the-scientific-subcommittee-on-control-of-anticoagulation-of-the-international-society-on-thrombosis-and-haemostasis
#6
J Harenberg, J Walenga, G Torri, O E Dahl, L Drouet, J Fareed
No abstract text is available yet for this article.
July 2013: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/23235959/market-entry-of-biosimilar-low-molecular-weight-heparins-in-europe-opportunities-and-challenges
#7
Steven Simoens, Isabelle Huys
This article examines the market entry of biosimilar low-molecular-weight heparins (LMWHs) in Europe by focusing on regulatory requirements, pricing, reimbursement, prescribing, and dispensing. The window for biosimilar LMWHs to enter the market is narrow on the supply side because of several factors. These include (1) regulatory requirements, including a quality dossier, clinical and nonclinical studies, pharmacodynamic and pharmacokinetic studies, immunogenicity studies, and a comparability exercise (but a reduction in clinical data requirements might be plausible in some cases); (2) prices of originator LMWHs are lower than those of other biologic products; (3) European prices of originator LMWHs are lower than those observed in the rest of the world; (4) research and development and manufacturing costs are substantial; (5) costs of active pharmaceutical ingredients have increased following the heparin contamination crisis; and (6) biosimilar LMWHs may be subjected to generic medicine pricing regulations...
April 2013: Seminars in Thrombosis and Hemostasis
https://www.readbyqxmd.com/read/23153556/low-molecular-weight-heparins-copies-are-they-considered-to-be-generics-or-biosimilars
#8
REVIEW
Paola Minghetti, Francesco Cilurzo, Silvia Franzé, Umberto M Musazzi, Manuela Itri
The protection rights of low molecular weight heparins (LMWHs) are expired or are expiring, so the extent and nature of the studies required to obtain a market authorization for LMWH copies represents a hot topic. FDA classifies LMWHs as semisynthetic drugs and their copies as generics whereas the EMA views them as biological medicines and consequently their copies as biosimilars. Consequently, FDA requires only in vivo pharmacodynamic studies, while EMA requires also clinical trials. The current work reviews the chemical composition and therapeutic indications of LMWHs available in the EU and USA markets to discuss the two different approaches...
March 2013: Drug Discovery Today
https://www.readbyqxmd.com/read/22466973/ensuring-safety-of-biosimilar-low-molecular-weight-heparins-a-consensus-statement-of-the-international-union-of-angiology
#9
J Harenberg, E Kalodiki, J M Walenga
No abstract text is available yet for this article.
April 2012: International Angiology: a Journal of the International Union of Angiology
https://www.readbyqxmd.com/read/22323327/propositional-debate-on-biosimilar-enoxaparin-in-brazil
#10
Paulo A S Mourão, Bianca F Glauser, Bruno C Vairo, Mariana S Pereira
Some patents of low-molecular-weight heparins (LMWHs) have expired and others are about to expire. Biosimilar versions of those drugs are available for clinical use in several countries. However, skepticism persists about the possibility of obtaining preparations similar to the original drug, because of the complexity of the process to generate LMWHs. In recent years, our laboratory has analyzed biosimilar samples of enoxaparin available for clinical use in Brazil (30 different batches and 70 finished products)...
January 2012: Arquivos Brasileiros de Cardiologia
https://www.readbyqxmd.com/read/22275388/a-comparison-of-the-pharmacodynamic-behavior-of-branded-and-biosimilar-enoxaparin-in-primates
#11
COMPARATIVE STUDY
Walter Jeske, Evangelos Litinas, Hussein Khan, Debra Hoppensteadt, Jawed Fareed
Pharmacodynamic behavior of branded and biosimilar enoxaparin was compared in a crossover study in primates. Blood samples collected at baseline and at 1, 4, 6, and 28 hours post-subcutaneous administration of Lovenox or Fibrinox were evaluated using clot-based and amidolytic assays. Anti-Xa levels following Fibrinox and Lovenox administration were not different. Anti-IIa levels were significantly higher in Lovenox-treated animals 1 to 6 hours post-administration. Higher drug levels were measured by Heptest in Fibrinox-treated animals from 4 to 6 hours...
June 2012: Clinical and Applied Thrombosis/hemostasis
https://www.readbyqxmd.com/read/22274818/low-molecular-weight-heparin-biosimilars-how-much-similarity-for-how-much-clinical-benefit
#12
REVIEW
Ludovic Drouet
The development of biosimilar versions of low molecular weight heparins (LMWHs) raises real medical concerns. To illustrate this, we have chosen as an example the specific clinical setting of antithrombotic management of acute coronary syndromes (ACS). In this indication, the LMWH enoxaparin has consistently shown its superiority in terms of efficacy when compared to unfractionated heparin (UFH) and in a number of direct or indirect comparisons to other LMWHs. For this reason, enoxaparin has become the gold standard for anticoagulation in cardiology, recommended by practice guidelines and extensively used in everyday practice...
March 2012: Targeted Oncology
https://www.readbyqxmd.com/read/22234312/a-review-of-the-two-major-regulatory-pathways-for-non-proprietary-low-molecular-weight-heparins
#13
REVIEW
Frederick A Ofosu
With the expiry or pending expiry of originator low-molecular-weight heparin (LMWH) patents, pharmaceutical companies have invested in developing non-proprietary versions of LMWHs. LMWHs are manufactured by depolymerising highly purified unfractionated heparin. In contrast to traditional synthetic drugs with well-defined chemical structures, LMWHs contain complex oligosaccharide mixtures and the different manufacturing processes for LMWHs add to the heterogeneity in their physicochemical properties such that the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) consider existing originator LMWHs to be distinct medicinal entities that are not clinically interchangeable...
February 2012: Thrombosis and Haemostasis
https://www.readbyqxmd.com/read/21838658/regulatory-considerations-for-generic-or-biosimilar-low-molecular-weight-heparins
#14
REVIEW
Alfredo García-Arieta, Antonio Blázquez
The aim of the present paper is to address the legal aspects, technical requirements and possible conditions of use associated to low molecular weight heparin generics and biosimilars that are arriving to the market in United States and the European Union, respectively. To this end the concept of "similar biological medicinal product" that was coined in 2003 by the pharmaceutical legislation of the European Union is compared to the concept of generic in the United States and the concept of generic in the European Union...
June 1, 2012: Current Drug Discovery Technologies
https://www.readbyqxmd.com/read/21455866/low-molecular-weight-heparins-differ-substantially-impact-on-developing-biosimilar-drugs
#15
Jeanine M Walenga, Craig M Jackson, Craig M Kessler
Generic drugs are an important component for meaningful health-care reform currently being debated in the United States. Aside from defining the period of drug exclusivity, however, there is a critical need to ensure that generics of biologic medicines (biosimilars) are safe and effective. For low molecular weight heparins (LMWHs), the standard of care for management of venous thromboembolism, their complex structure and polypharmacological actions make producing a generic LMWH more challenging than a generic small molecule medicine...
April 2011: Seminars in Thrombosis and Hemostasis
https://www.readbyqxmd.com/read/21443789/differentiation-of-parenteral-anticoagulants-in-the-prevention-and-treatment-of-venous-thromboembolism
#16
Jawed Fareed, Cafer Adiguzel, Indermohan Thethi
BACKGROUND: The prevention of venous thromboembolism has been identified as a leading priority in hospital safety. Recommended parenteral anticoagulant agents with different indications for the prevention and treatment of venous thromboembolism include unfractionated heparin, low-molecular-weight heparins and fondaparinux. Prescribing decisions in venous thromboembolism management may seem complex due to the large range of clinical indications and patient types, and the range of anticoagulants available...
2011: Thrombosis Journal
https://www.readbyqxmd.com/read/21220365/an-open-label-non-randomized-prospective-clinical-trial-evaluating-the-immunogenicity-of-branded-enoxaparin-versus-biosimilars-in-healthy-volunteers
#17
MULTICENTER STUDY
Marise Gomes, Eduardo Ramacciotti, Debra Hoppensteadt, Jeanine M Walenga, Bruce Lewis, Indermohan Thethi, Jawed Fareed
INTRODUCTION: Compositional variations among biosimilar enoxaparin could lead to a differential immunogenic response between these preparations. METHODS: Enoxaparin (Clexane, n = 110) and a biosimilar version (Cutenox, n = 110) were administered to healthy volunteers in Brazil, 40 mg subcutaneous (SQ), daily, for 10 days. Blood was collected at baseline, days 1 and 10, and analyzed for antiheparin/PF4 antibody (AHPF4 antibodies) titers and subtypes by enzyme-linked-immunosorbent serologic assay (ELISA)...
February 2011: Clinical and Applied Thrombosis/hemostasis
https://www.readbyqxmd.com/read/21180780/-critical-analysis-of-criteria-for-the-evaluation-of-low-molecular-weight-heparin-biosimilars
#18
Valdair F Pinto, Miguel Antonio Moretti, Antonio Carlos P Chagas
No abstract text is available yet for this article.
October 2010: Arquivos Brasileiros de Cardiologia
https://www.readbyqxmd.com/read/21159711/new-and-generic-anticoagulants-and-biosimilars-safety-considerations
#19
REVIEW
Evi Kalodiki, Jawed Fareed
The recent health care changes and approval of a generic low-molecular-weight heparin (LMWH) by the US Food and Drug Administration (FDA) merit a review of the facts regarding the new and generic anticoagulants. Fatal hypotension from anaphylactoid type reactions following heparin administration was responsible for more than 149 deaths all over the world. Researchers detected a heparin-like semisynthetic contaminant, over-sulfated chondroitin sulfate (OSCS), that appeared to be intentional. Low-molecular-weight heparins are produced using unfractionated heparin and OSCS has been found in various batches of LMWHs...
April 2011: Clinical and Applied Thrombosis/hemostasis
https://www.readbyqxmd.com/read/21159709/the-united-states-food-and-drugs-administration-approves-a-generic-enoxaparin
#20
Frederick A Ofosu
The Food and Drug Administration (FDA) approved on July 23, 2010, the abbreviated new drug application (ANDA) by Sandoz Inc for a generic enoxaparin (Lovenox) as the FDA is satisfied with the active ingredient ''sameness'' and the interchangeability of Lovenox with this generic version. Regulatory authorities that consider low-molecular-weight heparins (LMWHs) as drugs approve generic LMWHs via an ANDA pathway, whereas EMEA views them as biological medicines and will therefore regulate copies of LMWHs via a biosimilar pathway because only similar copies can be manufactured...
February 2011: Clinical and Applied Thrombosis/hemostasis
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