keyword
MENU ▼
Read by QxMD icon Read
search

Biosimilars

keyword
https://www.readbyqxmd.com/read/29149321/biosimilars-forum-applauds-food-and-drug-administration-on-new-educational-program-promoting-safety-and-effectiveness-of-biosimilars
#1
(no author information available yet)
No abstract text is available yet for this article.
November 14, 2017: Rheumatology
https://www.readbyqxmd.com/read/29149243/biosimilars-in-oncology-much-ado-about-nothing
#2
M Aapro
No abstract text is available yet for this article.
November 15, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29149162/-switching-from-one-drug-therapy-to-another-with-the-same-therapeutic-indication-without-harms
#3
Valeria Belleudi, Antonio Addis
The loss of exclusivity from several drug therapies largely used bring new attention the issues of safety, efficacy and following the switch from one drug to another (i.e., biosimilar and/or generics) with the same indication. This is not a problem that can be related to regulatory or economical factors. The increase of patients exposed to chronic conditions and the introductions or more pharmaceutical alternatives with same therapeutic indications yield for studies able to verify the effectiveness and safety even when switch from more drugs is considered by practitioners...
November 2017: Recenti Progressi in Medicina
https://www.readbyqxmd.com/read/29145936/biosimilars-state-of-clinical-and-regulatory-science
#4
Agnes Victoria Klein, Jian Wang, Brian G Feagan, Mark Omoto
On May 12, 2017, various issues and challenges associated with biologics were discussed during a session of the annual joint conference of Canadian Society for Pharmaceutical Sciences and Canadian Chapter of Controlled Release Society at Hyatt Regency Hotel, Montréal, QC, Canada.  An update on the Canadian regulatory guidelines for biosimilars was given, followed by viewpoints expressed by regulatory, academic and industry scientists.  Topics of discussion included: reference biologic drug, clinical considerations, immunogenicity, extrapolation and clarification of terminology, product monograph, international collaboration, switching and interchangeability, naming conventions, clinical and non-clinical evaluation, authorization of indications, statistical equivalence, the nor-switch study and biologics marketplace...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29145025/coupling-of-on-column-trypsin-digestion-peptide-mapping-and-principal-component-analysis-for-stability-and-biosimilarity-assessment-of-recombinant-human-growth-hormone
#5
Sara M Shatat, Basma M Eltanany, Abeer A Mohamed, Medhat A Al-Ghobashy, Faten A Fathalla, Samah S Abbas
Peptide mapping (PM) is a vital technique in biopharmaceutical industry. The fingerprint obtained helps to qualitatively confirm host stability as well as verify primary structure, purity and integrity of the target protein. Yet, in-solution digestion followed by tandem mass spectrometry is not suitable as a routine quality control test. It is time consuming and requires sophisticated, expensive instruments and highly skilled operators. In an attempt to enhance the fuctionality of PM and extract multi-dimentional data about various critical quality attributes and comparability of biosimilars, coupling of PM generated using immobilized trypsin followed by HPLC-UV to principal component analysis (PCA) is proposed...
November 11, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/29144116/-the-importance-of-biosimilars-medicines-for-private-and-statutory-health-insurance
#6
B Bretthauer
Patented biopharmaceuticals generate huge costs for private and statutory health insurance. Exactly ten years ago, off-patent biopharmaceuticals, also referred to as 'biosimilars medicines', became available as a more cost-efficient and therapeutically equivalent alternative in Germany and Europe. Following their approval by all the relevant authorities, biosimilars medicines can therefore be applied in the same way as previously patented biopharmaceuticals.
December 15, 2016: Versicherungsmedizin
https://www.readbyqxmd.com/read/29144113/-can-we-transfer-the-mechanisms-of-the-generics-market-to-biosimilars
#7
Ch O Jacke, F Wild
Personalized medicines such as biologics and their generic equivalents, biosimilars, are pouring onto the pharmaceutical markets. Data of 16 private health insurance companies were used to describe the market shares of selected biosimilars available in 2014 and 2015. The purpose of this study focuses on the question of whether market access of biosimilars will lead to a price competition of the expense of innovation competition. The results show that prescriptions of biosimilars made up 37% of total prescriptions in 2015 compared to 35% in 2014, and that their share of prescription costs went up from 21% to 23% in the same period...
December 15, 2016: Versicherungsmedizin
https://www.readbyqxmd.com/read/29129095/trastuzumab-biosimilar-in-early-breast-cancer-setting-will-there-be-direct-patient-benefits
#8
Arlene Chan
No abstract text is available yet for this article.
October 2017: Chinese Clinical Oncology
https://www.readbyqxmd.com/read/29127626/impact-of-infliximab-and-etanercept-biosimilars-on-biological-disease-modifying-antirheumatic-drugs-utilisation-and-nhs-budget-in-the-uk
#9
Mohammed I Aladul, Raymond W Fitzpatrick, Stephen R Chapman
OBJECTIVE: Biological disease-modifying antirheumatic drugs (bDMARDs) are effective but expensive options for treating rheumatoid arthritis. The introduction of infliximab and etanercept biosimilars presents a significant potential cost saving in a financially constrained health system such as the National Health Service (NHS) in the UK. This study examines the impact of the introduction of infliximab and etanercept biosimilars on the utilisation of bDMARDs and subsequent budget impact...
November 10, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29124994/a-review-on-biosimilar-infliximab-ct-p13-in-the-treatment-of-inflammatory-bowel-disease
#10
Klaudia Farkas, Tamás Molnár
The introduction of biological agents has led to significant changes in the treatment of inflammatory bowel disease (IBD). The relatively high price of infliximab (IFX) and the expiration of the patents led to the introduction of biosimilar agents. CT-P13 was the first IFX biosimilar approved in the same indications as the reference product; however, the approval was based on randomized clinical trials conducted in patients with rheumatoid arthritis and ankylosing spondylitis. In the past 2-3 years, new findings from prospective observational studies supported the short-, medium- and long-term clinical efficacy and safety of CT-P13 in patients with IBD...
November 10, 2017: Immunotherapy
https://www.readbyqxmd.com/read/29123576/the-efficacy-and-safety-of-the-biosimilar-product-inflectra-%C3%A2-compared-to-the-reference-drug-remicade-%C3%A2-in-rescue-therapy-in-adult-patients-with-ulcerative-colitis
#11
Magdalena Kaniewska, Andrzej Moniuszko, Grażyna Rydzewska
Introduction: The biosimilar product Inflectra(®) has been approved by the European Medicine Agency (EMA) for the same indications as its reference drug, infliximab, based on studies in patients with rheumatic diseases. Thus far, there have not been enough data regarding its efficacy and safety in ulcerative colitis (UC). Aim: To assess the efficacy and safety of the biosimilar product Inflectra(®) in comparison with its reference biological agent (Remicade(®)) in rescue therapy in adult patients presenting with severe exacerbation of UC, as well as to evaluate recurrence rate during a 6-month observation after finish of treatment...
2017: Przegla̜d Gastroenterologiczny
https://www.readbyqxmd.com/read/29122813/american-heart-association-principles-on-the-accessibility-and-affordability-of-drugs-and-biologics-a-presidential-advisory-from-the-american-heart-association
#12
REVIEW
Elliott M Antman, Mark A Creager, Steven R Houser, John J Warner, Madeleine Konig
Net US spending on pharmaceuticals reached $309.5 billion in 2015, an 8.5% increase from the year before, and is expected to reach between $370 and $400 billion by 2020. These current and projected levels have raised serious concerns by policy makers, providers, payers, and patient groups that they are unsustainable and threaten the affordability of and accessibility to much-needed therapies for patients. Two trends related to drugs/biologics and generic drugs/biosimilars underlie this overall increase in spending...
November 9, 2017: Circulation
https://www.readbyqxmd.com/read/29116927/financial-costs-associated-with-monopolies-on-biologic-medicines-in-australia
#13
Deborah Gleeson, Belinda Townsend, Ruth Lopert, Joel Lexchin, Hazel Moir
Objectives The aim of the study was to estimate the potential savings to the Pharmaceutical Benefits Scheme (PBS) and the Repatriation Pharmaceutical Benefits Scheme (RPBS) in 2015-16 if biosimilar versions of selected biologic medicines (biologics) had been available and listed on the PBS.Methods The research involved retrospective analysis of Australian Medicare expenditure data and PBS price data from 2015-16 for biologics, for which biosimilar competition may be available in future, listed on the PBS.Results Australian Government expenditure on biologics on the PBS and RPBS was estimated at A$2...
November 9, 2017: Australian Health Review: a Publication of the Australian Hospital Association
https://www.readbyqxmd.com/read/29114816/first-biosimilar-to-treat-cancer
#14
Rebecca Voelker
No abstract text is available yet for this article.
November 7, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/29113922/current-japanese-regulatory-systems-for-generics-and-biosimilars
#15
Ryosuke Kuribayashi, Kenji Sawanobori
Currently, biosimilar products are being actively developed around the world. One reason for this is the expiry of patents of original biopharmaceutical products with an extremely large market share because the biosimilar companies need to avoid infringing patents. A representative example of this is biosimilar versions of monoclonal antibodies. In Japan, the Ministry of Health, Labour and Welfare is promoting the use of biosimilar products because the market share of such products is currently extremely low compared with that of generic products...
November 4, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29113760/strengths-weaknesses-and-future-challenges-of-biosimilars-development-an-opinion-on-how-to-improve-the-knowledge-and-use-of-biosimilars-in-clinical-practice
#16
Cristina Scavone, Concetta Rafaniello, Liberato Berrino, Francesco Rossi, Annalisa Capuano
Biosimilars started receiving the marketing authorization by European Medicine Agency since 2006. The development of biosimilars follows a well-defined step-wise approach, the so-called comparability exercise, which aims to compare non-clinical (mainly quality features and biological activity) and clinical (efficacy and safety profiles) features of new biosimilars with their respective reference products. Despite the undeniable advantages of such procedure, some concerns (such as the absence of switching studies or the evaluation of efficacy and safety in all therapeutic indications) still exist about its...
November 4, 2017: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/29109610/how-similar-are-biosimilars-what-do-clinicians-need-to-know-about-biosimilar-and-follow-on-insulins
#17
Curtis Triplitt, Debbie Hinnen, Virginia Valentine
IN BRIEF As more patents on biological medicines expire, increased numbers of biologic copies, referred to as "biosimilars," will likely become available in the United States in the coming years. With greater availability and the drive for health care savings, the use of biosimilars and of "follow-on" biological products is likely to increase in routine clinical practice. Health care practitioners need to be fully aware of these products and accompanying considerations if they are to make informed decisions together with their patients...
October 2017: Clinical Diabetes: a Publication of the American Diabetes Association
https://www.readbyqxmd.com/read/29109389/overlooked-short-toxin-like-proteins-a-shortcut-to-drug-design
#18
Michal Linial, Nadav Rappoport, Dan Ofer
Short stable peptides have huge potential for novel therapies and biosimilars. Cysteine-rich short proteins are characterized by multiple disulfide bridges in a compact structure. Many of these metazoan proteins are processed, folded, and secreted as soluble stable folds. These properties are shared by both marine and terrestrial animal toxins. These stable short proteins are promising sources for new drug development. We developed ClanTox (classifier of animal toxins) to identify toxin-like proteins (TOLIPs) using machine learning models trained on a large-scale proteomic database...
October 29, 2017: Toxins
https://www.readbyqxmd.com/read/29108928/transitioning-from-first-to-second-generation-biosimilars-an-appraisal-of-regulatory-and-post-marketing-challenges
#19
REVIEW
Corrado Blandizzi, Mauro Galeazzi, Guido Valesini
Second-generation biosimilars (i.e. monoclonal antibodies or proteins generated by fusion of antibody and receptor moieties) differ in several respects as compared to first-generation ones (e.g. epoetins, bone marrow stimulating factors, somatotropins). In this respect, as second-generation biosimilars are endowed with much greater structural and molecular complexity, which might translate into a number of pharmacological and therapeutic issues, they raise new challenges for manufacturers and regulatory authorities as well as new concerns for clinicians...
November 3, 2017: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/29104764/reply-to-biosimilars-a-position-paper-of-the-european-society-for-medical-oncology-with-particular-reference-to-oncology-prescribers
#20
Georgios Bakalos, Thomas Schreitmüller
No abstract text is available yet for this article.
2017: ESMO Open
keyword
keyword
26298
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"