keyword
MENU ▼
Read by QxMD icon Read
search

Biologics/ Biosimilars

keyword
https://www.readbyqxmd.com/read/28439817/developing-the-totality-of-evidence-for-biosimilars-regulatory-considerations-and-building-confidence-for-the-healthcare-community
#1
REVIEW
Richard Markus, Jennifer Liu, Monica Ramchandani, Diana Landa, Teresa Born, Primal Kaur
Biosimilars are highly similar versions of approved branded biologics. Unlike generics, they are not exact replicas of reference products. Minor differences between biosimilars and reference products in some aspects are expected; likewise, biosimilar products will differ from each other. The objective of this review is to discuss the challenges associated with the development and approval of biosimilar products that are unique because of their complex structure and specialized manufacturing processes, which can impact not only efficacy but also immunogenicity and safety...
April 24, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28434387/cost-utility-of-biological-treatment-sequences-for-luminal-crohn-s-disease-in-europe
#2
Fanni Rencz, László Gulácsi, Márta Péntek, Krisztina B Gecse, Axel Dignass, Jonas Halfvarson, Fernando Gomollón, Petra Baji, Laurent Peyrin-Biroulet, Péter L Lakatos, Valentin Brodszky
OBJECTIVES: To compare the cost-effectiveness of treatment sequences with available biologics, including adalimumab (ADA), biosimilar infliximab (bsIFX), originator infliximab (IFX) and vedolizumab (VEDO) for luminal Crohn's disease in nine European countries. METHODS: A Markov-model was constructed to simulate five-year medical costs and quality-adjusted life years (QALYs). Data on clinical efficacy were obtained from randomised controlled trials. Country-specific unit costs, discount rates and a third-party payer perspective were applied...
April 24, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/28433587/pharmacokinetic-and-toxicology-comparator-testing-of-biosimilar-drugs-assessing-need
#3
Paul Baldrick
A key element in the development of a biosimilar molecule is the comparability of the biological activity/nonclinical similarity to the innovator drug. Although some regulatory guidelines are encouraging little or no in vivo testing, currently a common practice is to perform at least one toxicology and/or one pharmacokinetic (PK) study to assess if any different findings occur for in-life, clinical pathology and histopathological parameters or in exposure. An exercise was performed in which the results of such testing were evaluated...
April 20, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28426178/multiplexing-n-glycan-analysis-by-dna-analyzer
#4
Hua-Tao Feng, Pingjing Li, Guo Rui, James Stray, Shaheer Khan, Shiaw-Min Chen, Sam F Y Li
Analysis of N-glycan structures has been gaining attentions over the years due to their critical importance to biopharma based applications and growing roles in biological research. Glycan profiling is also critical to the development of biosimilar drugs. The detailed characterization of N-glycosylation is mandatory because it is a non-template driven process and that significantly influences critical properties such as bio-safety and bio-activity. The ability to comprehensively characterize highly complex mixtures of N-glycans has been analytically challenging and stimulating because of the difficulties in both the structure complexity and time-consuming sample pretreatment procedures...
April 20, 2017: Electrophoresis
https://www.readbyqxmd.com/read/28424972/biosimilars-in-the-united-states-emerging-issues-in-litigation
#5
REVIEW
Alice Yuen-Ting Wong, Martha M Rumore, Albert Wai-Kit Chan
Many first-generation biologics will lose their patent protection by 2020. The biosimilars market is not only attractive but also competitive and tough. The United States (US) is the world's largest pharmaceutical market and is critical to the success of most drugs. However, unclear regulatory requirements and confusing patent resolution procedures create hurdles to market entry of biosimilars. Trade secret exposure and scant exclusivity and adoption also limit the market access of biosimilars. Both biologics and biosimilar developers should closely follow the regulatory and litigation landscape to successfully navigate through the challenges...
April 19, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28416374/comparing-originator-biologics-and-biosimilars-a-review-of-the-relevant-issues
#6
REVIEW
Corrado Blandizzi, Pier Luigi Meroni, Giovanni Lapadula
PURPOSE: We provide a review of current knowledge on comparability between biosimilars and originator biologics in view of the continuous evolution occurring in this highly dynamic area. METHODS: English-language literature indexed in MEDLINE was explored, without time limits, to July 31, 2016, using the terms biosimilar, biotechnologic drug, biologic drug, monoclonal antibody, fusion protein, and anti-tumor necrosis factor. The reference lists of identified articles were examined carefully for additional pertinent publications...
April 14, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28410403/assessing-gastroenterologist-and-patient-acceptance-of-biosimilars-in-ulcerative-colitis-and-crohn-s-disease-across-germany
#7
Emma Sullivan, James Piercy, John Waller, Christopher M Black, Sumesh Kachroo
OBJECTIVES: This study examined gastroenterologists' motivation for prescribing biosimilars, assessed their treatment preferences in relation to prescribing behaviour, and explored patient attitudes to biosimilars. METHODS: Data were taken from the Adelphi Real World Biosimilars Programme, a real-world, cross-sectional study undertaken in 2015-2016 with German gastroenterologists and patients with ulcerative colitis or Crohn's disease. Gastroenterologists provided data on their prescribing behaviour and attitudes towards biosimilars, and invited the next eight eligible consecutive consulting patients to complete a detailed questionnaire...
2017: PloS One
https://www.readbyqxmd.com/read/28403267/the-current-state-of-dermatologists-familiarity-and-perspectives-of-biosimilars-for-the-treatment-of-psoriasis-a-global-cross-sectional-survey
#8
Iviensan F Manalo, Kathleen E Gilbert, Jashin J Wu
<p>BACKGROUND: Biologic patent expiration, accelerated approval pathways, and business interests of third party payers and the biopharmaceutical industry are driving the development of biosimilars to treat immune-mediated disorders like psoriasis. No studies have investigated dermatologists' familiarity and perspectives of biosimilars.</p> <p>OBJECTIVES: To assess: (1) dermatologists' familiarity with biosimilars and interchangeability and (2) their perspectives toward biosimilar properties, including interchangeability, indication extrapolation, and immunogenicity risk...
April 1, 2017: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/28401824/-biosimilar-registered-despite-the-netherlands-opposing-vote-greater-uncertainty-about-authorised-drugs-in-the-netherlands
#9
A G Vulto
On 1 April 2016 the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on a new biological medicine, Flixabi®, a biosimilar to infliximab (Remicade®); however, in the appendix of the European Public Assessment Report (EPAR) it appeared that an important minority (14 of 33 votes) opposed this decision, among them the Netherlands representative. In an original article, the Dutch Medicines Board (CBG-MEB) explained the reason for this decision, but still allowed the drug on the market...
2017: Nederlands Tijdschrift Voor Geneeskunde
https://www.readbyqxmd.com/read/28400458/what-drives-the-prescribing-of-growth-hormone-preparations-in-england-prices-versus-patient-preferences
#10
Stephen R Chapman, Raymond W Fitzpatrick, Mohammed I Aladul
OBJECTIVE: The patent expiry of a number of biological medicines and the advent of biosimilars raised the expectations of healthcare commissioners that biosimilars would reduce the high cost of these medicines and produce potential savings to the NHS. We aimed to examine the prescribing pattern of different growth hormone preparations (ready to use and reconstitution requiring) in primary and secondary care in England to determine relative rates of decrease or increase and identify the possible factors influencing prescribing following the introduction of biosimilar growth hormone in 2008...
April 11, 2017: BMJ Open
https://www.readbyqxmd.com/read/28393687/biosimilars-for-the-management-of-inflammatory-bowel-diseases-economic-considerations
#11
Laszlo Gulacsi, Marta Pentek, Fanni Rencz, Valentin Brodszky, Petra Baji, Zsuzsanna Vegh, Krisztina B Gecse, Silvio Danese, Laurent Peyrin-Biroulet, Peter L Lakatos
Biological drugs revolutionized the treatment of inflammatory bowel diseases (IBD) such as Crohn's disease and ulcerative colitis. However, not all clinically eligible patients have access to biologicals, due to significant costs and budget impact. Biosimilars are highly comparable to their originator product in terms of clinical efficacy and safety. Biosimilars are priced 15-75% lower than their reference product, which makes them a less costly alternative and is expected to offer better patients access to biologicals...
April 6, 2017: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/28389456/analytic-characterization-of-biosimilars
#12
Peter M Sullivan, Lisa M DiGrazia
PURPOSE: The biosimilar development process, comparability for biological agents, and analytic characterization of biosimilars are described. SUMMARY: Healthcare providers must understand the requirements for biosimilar approval, including the science behind biosimilar development and testing that contributes to the totality of evidence. The foundation of development is to demonstrate that a biosimilar is highly similar to the reference product through analytic characterization...
April 15, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28386738/manufacturing-of-recombinant-human-follicle-stimulating-hormone-ovaleap-%C3%A2-xm17-comparability-with-gonal-f-%C3%A2-and-performance-consistency
#13
Rainer Winstel, Juergen Wieland, Beate Gertz, Arnd Mueller, Hermann Allgaier
Ovaleap(®) (XM17) is a recombinant human follicle-stimulating hormone to treat infertility by inducing ovulation or controlled ovarian stimulation for assisted reproductive technology (ART) procedures. Ovaleap(®) (follitropin-α) was approved by the European Medicines Agency in 2013 as a biosimilar medicinal product to the reference medicine, Gonal-f(®). Information is often not easily accessible and/or publicly available regarding the rigorous manufacturing procedures for biosimilars. Objectives of the current analysis were to report on validation procedures for the Ovaleap(®) manufacturing process, to compare the characteristics of Ovaleap(®) versus Gonal-f(®), and to describe the performance and consistency of Ovaleap(®)...
April 6, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28381912/fda-pleases-no-one-with-final-guidance-on-naming-of-biologicals-and-biosimilars
#14
Stephen Barlas
FDA pleases no one with final guidance on biological and biosimilar naming.
April 2017: P & T: a Peer-reviewed Journal for Formulary Management
https://www.readbyqxmd.com/read/28375404/hot-topics-in-primary-care-demystifying-the-differences-follow-on-biologics-biosimilars-and-generics
#15
REVIEW
Eugene E Wright, Thomas C Blevins, Beverly Reed, Roy Daniel Pollom
Sponsors of follow-on biologics can submit their applications for approval by the US Food and Drug Administration (FDA) under 2 distinct pathways. The submission pathway is determined by the pathway previously used by the reference biologic product, which is the biologic product upon which the follow-on product relies for evidence of safety and efficacy.
April 2017: Journal of Family Practice
https://www.readbyqxmd.com/read/28373759/insights-on-the-use-of-biosimilars-in-the-treatment-of-inflammatory-bowel-disease
#16
REVIEW
Michael K Zheng, David Q Shih, Gary C Chen
Biologic therapy, such as those that target tumor necrosis factor (TNF) signaling, has proven to be an efficacious method of treatment for patients with inflammatory bowel disease (IBD) with regards to symptom management and mucosal healing. However, the rising prevalence of IBD worldwide and the ever-increasing burden of biologic pharmaceuticals in the health care industry is alarming for insurance companies, clinicians, and patients. The impending patent expiry and the relatively high costs of biologics, particularly anti-TNF agents, have paved the way for biosimilar development for IBD...
March 21, 2017: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/28371718/comparability-study-of-rituximab-originator-and-follow-on-biopharmaceutical
#17
Othman Montacir, Houda Montacir, Murat Eravci, Andreas Springer, Stephan Hinderlich, Amirhossein Saadati, Maria Kristina Parr
Immunglobolin G (IgG)-based biopharmaceuticals are emerging on the pharmaceuticals market due to their high target selectivity in different diseases. In parallel, a growing interest by other companies to produce similar or highly similar follow-on biologics exits, once the patent of blockbuster biotherapeutics is about to expire. In correlation to their complex structure, an analytical challenge is facing the approval of these biosimilars. Health authorities (e.g. FDA and EMA) have issued several guidelines to define critical quality attributes during manufacturing process changes...
June 5, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28365979/a-multidimensional-analytical-comparison-of-remicade-and-the-biosimilar-remsima
#18
Karthik Pisupati, Yuwei Tian, Solomon Okbazghi, Alexander Benet, Rose Ackermann, Michael Ford, Sergei V Saveliev, Christopher M Hosfield, Marjeta Urh, Eric Carlson, Christopher Becker, Thomas J Tolbert, Steven P Schwendeman, Brandon T Ruotolo, Anna Schwendeman
In April 2016, the Food and Drug Administration approved the first biosimilar monoclonal antibody (mAb) - Inflectra/Remsima (Celltrion) based off the original product Remicade (infliximab, Janssen). Biosimilars promise significant cost savings for patients, but the unavoidable differences between innovator and copycat biologics raise questions regarding product interchangeability. In this study, Remicade and Remsima were examined by native mass spectrometry, ion mobility and quantitative peptide mapping. The levels of oxidation, deamidation and mutation of individual amino acids were remarkably similar...
April 1, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28349061/physicochemical-and-biological-characterization-of-the-proposed-biosimilar-tocilizumab
#19
Shiwei Miao, Li Fan, Liang Zhao, Ding Ding, Xiaohui Liu, Haibin Wang, Wen-Song Tan
HS628 has been developed as a proposed biosimilar product of originator tocilizumab (Actemra®). An extensive physicochemical and biological characterization was conducted to assess similarity between HS628 and originator tocilizumab. The amino acid sequence was shown to be identical between HS628 and originator tocilizumab. The higher order structure was found to be indistinguishable from originator tocilizumab. Concerning purity and heterogeneity, HS628 was demonstrated to have similar posttranslational modifications, charge heterogeneity, size heterogeneity, and glycosylation to originator tocilizumab...
2017: BioMed Research International
https://www.readbyqxmd.com/read/28344818/will-bevacizumab-biosimilars-impact-the-value-of-systemic-therapy-in-gynecologic-cancers
#20
REVIEW
Bradley J Monk, Warner K Huh, Julie Ann Rosenberg, Ira Jacobs
OBJECTIVE: Bevacizumab is an important component in the treatment of various cancers, and despite guidelines recommending its use in both ovarian and cervical cancer, patient access to bevacizumab and other angiogenesis inhibitors is limited. Biosimilars are large, structurally complex molecules that are intended to be highly similar to, and treat the same condition(s) as, an existing licensed or approved (reference) biologic, with no clinically meaningful differences in purity, potency and safety...
2017: Gynecologic Oncology Research and Practice
keyword
keyword
58566
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"