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Biologics/ Biosimilars

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https://www.readbyqxmd.com/read/28526943/a-global-reference-comparator-for-biosimilar-development
#1
Christopher J Webster, Gillian R Woollett
Major drug regulators have indicated in guidance their flexibility to accept some development data for biosimilars generated with reference product versions licensed outside their own jurisdictions, but most authorities require new bridging studies between these versions and the versions of them licensed locally. The costs of these studies are not trivial in absolute terms and, due to the multiplier effect of required repetition by each biosimilar sponsor, their collective costs are substantial. Yet versions of biologics licensed in different jurisdictions usually share the same development data, and any manufacturing changes between versions have been justified by a rigorous comparability process...
May 19, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28526658/nonclinical-pharmacology-and-toxicology-of-the-first-biosimilar-insulin-glargine-drug-product-basaglar-%C3%A2-abasaglar-%C3%A2-approved-in-the-european-union
#2
Richard A Byrd, Rebecca A Owens, Jamie L Blackbourne, David E Coutant, Mark W Farmen, M Dodson Michael, Julie S Moyers, A Eric Schultze, Michael K Sievert, Niraj K Tripathi, John L Vahle
Basaglar(®)/Abasaglar(®) (Lilly insulin glargine [LY IGlar]) is a long-acting human insulin analogue drug product granted marketing authorisation as a biosimilar to Lantus(®) (Sanofi insulin glargine [SA IGlar]) by the European Medicines Agency. We assessed the similarity of LY IGlar to the reference drug product, European Union-sourced SA IGlar (EU-SA IGlar), using nonclinical in vitro and in vivo studies. No biologically relevant differences were observed for receptor binding affinity at either the insulin or insulin-like growth factor-1 (IGF-1) receptors, or in assays of functional or de novo lipogenic activity...
May 16, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28510518/biosimilar-makers-hope-court-starts-6-month-wait-sooner
#3
Ed Silverman
The dispute centers on dueling interpretations of the Biologics Price Competition and Innovation Act, which says a company seeking to sell a biosimilar must give the maker of the brand-name biologic at least a 180-day notice before selling its drug.
March 2017: Managed Care
https://www.readbyqxmd.com/read/28496277/a-framework-for-integrating-biosimilars-into-the-didactic-core-requirements-of-a-doctor-of-pharmacy-curriculum
#4
REVIEW
Edward Li, Jennifer Liu, Monica Ramchandani
Biologic drugs approved via the abbreviated United States biosimilar approval pathway are anticipated to improve access to medications by addressing increasing health care expenditures. Surveys of health care practitioners indicate that there is inadequate knowledge and understanding about biosimilars; this must be addressed to ensure safe and effective use of this new category of products. Concepts of biosimilar development, manufacturing, regulation, naming, formulary, and inventory considerations, as well as patient and provider education should be included within the doctor of pharmacy (PharmD) curriculum as preparation for clinical practice...
April 2017: American Journal of Pharmaceutical Education
https://www.readbyqxmd.com/read/28495312/considerations-of-critical-quality-attributes-in-the-analytical-comparability-assessment-of-biosimilar-products
#5
Ohseok Kwon, Jeewon Joung, Younjoo Park, Chan Wha Kim, Seung Hwa Hong
Based on experience in clinical trial approvals and marketing authorizations for biosimilar products in Korea, we suggest principles for the analytical comparability assessment of biosimilar products with respect to regulatory considerations. The composition and manufacturing processes of biosimilar products can differ from those of the reference product depending on the information available for the reference product and the time of product development; however, the analytical characteristics of biosimilar products should be highly similar to those of the reference product...
May 8, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28482702/an-introduction-to-biosimilar-cancer-therapeutics-definitions-rationale-for-development-and-regulatory-requirements
#6
Christian Buske, Michinori Ogura, Hyuk-Chan Kwon, Sang Wook Yoon
Monoclonal antibodies and other biologic drugs play important roles in the treatment of various hematological malignancies and solid tumors. However, such drugs are intrinsically more expensive to develop than small molecules and their clinical benefits are often accompanied by challenges relating to affordability and access. Patent expiry for 'originator' biologics is providing opportunities for a new generation of biosimilar drugs, potentially capable of relieving pressure on healthcare budgets. This article discusses key characteristics of biosimilars, distinguishes them from generics and noncomparable biologics and outlines the robust regulatory requirements that must be followed to establish biosimilarity with a reference product...
May 2017: Future Oncology
https://www.readbyqxmd.com/read/28482701/looking-to-the-future-and-learning-lessons-from-the-recent-past-changing-stakeholder-perceptions-of-biosimilars-in-cancer
#7
Won Seog Kim, Michinori Ogura, Hyuk-Chan Kwon, Dasom Choi
As the patents for many biologic anticancer drugs expire, significant growth in the use of biosimilars is predicted, offering an opportunity to help combat the rising costs of treatment and increase patient access to biologic therapy. Attainment of regulatory approval, involving numerous nonclinical and clinical comparative studies versus each reference product, is only one of several barriers to realize the potential gains offered by biosimilars. It is important to understand the current perceptions and informational needs of different stakeholders if biosimilars are to be accepted and widely used in the clinic...
May 2017: Future Oncology
https://www.readbyqxmd.com/read/28482700/clinical-development-of-ct-p10-and-other-biosimilar-cancer-therapeutics
#8
Won Seog Kim, Bertrand Coiffier, Hyuk-Chan Kwon, SuYeon Kim
Biosimilars are highly similar versions of approved biologic drugs that may confer equivalent efficacy at a reduced cost. Patents for several biological cancer therapeutics are past or approaching expiry, presenting an opportunity to increase affordability and global accessibility of key drugs through the development of biosimilars. To receive approval, a biosimilar must show no clinically meaningful differences from the reference product in terms of efficacy or safety. The first monoclonal antibody biosimilar cancer therapeutic to gain approval was CT-P10, a biosimilar of rituximab...
May 2017: Future Oncology
https://www.readbyqxmd.com/read/28482699/scientific-rationale-for-extrapolation-of-biosimilar-data-across-cancer-indications-case-study-of-ct-p10
#9
Michinori Ogura, Bertrand Coiffier, Hyuk-Chan Kwon, Sang Wook Yoon
For a biosimilar to gain regulatory approval, a comprehensive comparability exercise must demonstrate that it is highly similar to its originator biologic, or reference product. Once biosimilarity has been shown, it is possible to approve the biosimilar for additional indications held by the reference product, without clinical trials in these indications. Extrapolation of clinical data is permitted by regulatory agencies as long as it is scientifically justified. CT-P10, a biosimilar of rituximab, was recently approved in Europe for all indications held by its reference product, incorporating both autoimmune diseases and hematological cancers...
May 2017: Future Oncology
https://www.readbyqxmd.com/read/28482698/preparing-for-a-new-generation-of-biologic-therapies-understanding-the-development-and-potential-of-biosimilar-cancer-therapeutics
#10
Bertrand Coiffier
No abstract text is available yet for this article.
May 2017: Future Oncology
https://www.readbyqxmd.com/read/28479860/rituximab-in-the-treatment-of-follicular-lymphoma-the-future-of-biosimilars-in-the-evolving-therapeutic-landscape
#11
REVIEW
Janakiraman Subramanian, Jamie Cavenagh, Bhardwaj Desai, Ira Jacobs
Follicular lymphoma (FL) is the second most common type of non-Hodgkin's lymphoma. FL is an incurable disease with treatment options ranging from a "watch-and-wait" approach to localized therapy with radiation or systemic therapy with rituximab in combination with chemotherapy regimens. This review summarizes the role of rituximab across the spectrum of FL treatment and the evolving therapeutic landscape with the emergence of novel agents currently in clinical development. Despite the prospect of new agents on the horizon, it is widely accepted that rituximab will remain as the cornerstone of therapy because of its established long-term efficacy...
2017: Cancer Management and Research
https://www.readbyqxmd.com/read/28477160/current-status-of-biosimilars-in-oncology
#12
REVIEW
Luis H Camacho
Four medicinal cancer biological blockbusters will end their patent lifespan by 2020. It is estimated that the total market for cancer biologicals will reach approximately US$68 billion at that time. Approximately 20 biosimilars have entered the European market since the launch of the original approval guidelines in 2005, and four biosimilars have been approved in the USA since 2015. Data from European countries with the highest market entrance of biosimilars suggest that the incorporation of biosimilars into healthcare systems worldwide may result in a 30-45% cost savings...
June 2017: Drugs
https://www.readbyqxmd.com/read/28475378/clinical-development-of-biologicals-and-biosimilars-safety-concerns
#13
Stefanos Bonovas, Laurent Peyrin-Biroulet, Silvio Danese
No abstract text is available yet for this article.
June 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28465779/is-a-biologic-produced-15-years-ago-a-biosimilar-of-itself-today
#14
Stanton R Mehr, Marj P Zimmerman
Much of the testing required for the regulatory approval of a biosimilar is focused on proving that the new drug is sufficiently similar to the reference biologic in structure, pharmacokinetics or pharmacodynamics, clinical efficacy, and safety. However, the reference drug may itself have gone through some changes in the years since its approval, including those caused by alterations in the manufacturing process. Do these changes increase the risk that the reference drug may cause unexpected outcomes? It is up to the US Food and Drug Administration to decide whether the changes merit the need for additional studies to confirm that the drug meets the structural or clinical outcomes standard for the reference agent...
December 2016: American Health & Drug Benefits
https://www.readbyqxmd.com/read/28462793/biosimilars-to-recombinant-human-fsh-medicines-comparable-efficacy-and-safety-to-the-original-biologic
#15
Fernando de Mora, Bart C J M Fauser
Two recombinant follicle-stimulating hormone (rFSH)-bearing similar biological medicines (biosimilars) have been authorized by the European Commission. Biosimilar is a regulatory concept alluding to the evidence-based high-standard comparability studies needed to demonstrate its equivalence to a reference original biologic. Because biosimilar development represents a shift from the long-lasting existing paradigms, a thorough understanding of the science behind it will contribute to helping prescribers make informed treatment choices...
April 10, 2017: Reproductive Biomedicine Online
https://www.readbyqxmd.com/read/28454057/application-of-2d-nmr-with-room-temperature-nmr-probes-for-the-assessment-of-the-higher-order-structure-of-filgrastim
#16
Robert G Brinson, Houman Ghasriani, Derek J Hodgson, Kristie M Adams, Ian McEwen, Darón I Freedberg, Kang Chen, David A Keire, Yves Aubin, John P Marino
The higher order structure (HOS) of biotherapeutics is a critical quality attribute that can be evaluated by nuclear magnetic resonance (NMR) spectroscopy at atomic resolution. NMR spectral mapping of HOS can be used to establish HOS consistency of a biologic across manufacturing changes or to compare a biosimilar to an innovator reference product. A previous inter-laboratory study performed using filgrastim drug products demonstrated that two-dimensional (2D)-NMR (1)H(N)-(15)N(H) heteronuclear correlation spectroscopy is a highly robust and precise method for mapping the HOS of biologic drugs at natural abundance using high sensitivity NMR 'cold probes...
April 4, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28453766/comparable-immune-function-inhibition-by-the-infliximab-biosimilar-ct-p13-implications-for-treatment-of-inflammatory-bowel-disease
#17
Ki Jung Lim, So Jung Lee, Sunghwan Kim, Su Yeon Lee, Min Seob Lee, Yoon A Park, Eun Jin Choi, Eun Beom Lee, Hwang Keun Jun, Jong Moon Cho, SooYoung Lee, Ki Sung Kwon, Byung Pil Lim, Myung-Shin Jeon, Eui Cheol Shin, Yong Sung Choi, Ella Fudim, Orit Picard, Miri Yavzori, Shomron Ben-Horin, Shin Jae Chang
Background and Aims: CT-P13 is the first biosimilar monoclonal antibody to infliximab, and was recently approved in the European Union, Japan, Korea, and USA for all six indications of infliximab. However, studies directly assessing the biologic activity of CT-P13 versus inflximab in the context of inflammatory bowel disease [IBD] are still scanty. In the present study, we aimed to compare the biological activities of CT-P13 and infliximab with specific focus on intestinal cells so as to gain insight into the potential biosimilarity of these two agents for treatment of IBD...
May 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28439817/developing-the-totality-of-evidence-for-biosimilars-regulatory-considerations-and-building-confidence-for-the-healthcare-community
#18
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
#19
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
#20
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
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