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Biologics/ Biosimilars

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https://www.readbyqxmd.com/read/29437532/using-a-dihydrofolate-reductase-based-strategy-for-producing-the-biosimilar-version-of-pertuzumab-in-cho-s-cells
#1
Amin Ramezani, Abbas Ghaderi
Targeted therapy using monoclonal antibodies (mAbs) against epidermal growth factor receptor-2 (ErbB2) has been utilized for the treatment of breast cancer, recently. Pertuzumab, one of the anti-ErbB2 mAbs, was approved by FDA in 2012 for the treatment of metastatic breast cancer. The aim of this study was to produce biosimilar version of pertuzumab in Chinese hamster ovary (CHO)-S cell line, and compare its ErbB2-binding and biological activities, with commercial drug, Perjeta. To this end, a dihydrofolate reductase (DHFR)-based strategy was used to produce a CHO-S stable cell pool capable of producing high levels of pertuzumab...
February 13, 2018: Monoclonal Antibodies in Immunodiagnosis and Immunotherapy
https://www.readbyqxmd.com/read/29431871/immunoassay-methods-used-in-clinical-studies-for-the-detection-of-anti-drug-antibodies-to-adalimumab-and-infliximab
#2
B Gorovits, D J Baltrukonis, I Bhattacharya, M A Birchler, D Finco, D Sikkema, M S Vincent, S Lula, L Marshall, T P Hickling
OBJECTIVE: To examine the assay formats used to detect anti-drug antibodies (ADA) in clinical studies of the anti-TNF monoclonal antibodies adalimumab and infliximab in chronic inflammatory disease and their potential impact on pharmacokinetic and clinical outcomes. METHODS: Using findings of a recent systematic literature review of the immunogenicity of 11 biologic/biosimilar agents, we conducted an ancillary qualitative review of a subset of randomized controlled trials and observational studies of the monoclonal antibodies against anti-tumor necrosis factor adalimumab and infliximab...
February 12, 2018: Clinical and Experimental Immunology
https://www.readbyqxmd.com/read/29430170/analytical-characterization-of-recombinant-hcg-and-comparative-studies-with-reference-product
#3
Rajamannar Thennati, Sanjay Kumar Singh, Nitin Nage, Yena Patel, Sandip Kumar Bose, Vinod Burade, Ranjit Sudhakar Ranbhor
Introduction: Regulatory agencies recommend a stepwise approach for demonstrating biosimilarity between a proposed biosimilar and reference biological product emphasizing for functional and structural characterization to trace if there is any difference which may impact safety and efficacy. We studied the comparative structural and biological attributes of recombinant human chorionic gonadotropin (rhCG), SB005, with reference product, Ovidrel ® and Ovitrelle ® . Recombiant hCG was approved in 2000 by the US Food and Drug Administration for the induction of final follicular maturation, early luteinization in infertile women as part of assisted reproductive technology program...
2018: Biologics: Targets & Therapy
https://www.readbyqxmd.com/read/29428205/biosimilars-concepts-and-controversies
#4
REVIEW
Reyes Gámez-Belmonte, Cristina Hernández-Chirlaque, María Arredondo-Amador, Carlos J Aranda, Raquel González, Olga Martínez-Augustin, Fermín Sánchez de Medina
Biosimilars are copies of reference biological drugs, developed as the patents for original biologicals expire. They are thus developed to replicate an original biological medicine just a generics are intended to replicate a chemically-synthesized medicine; however, there are important technical and regulatory differences between the two. Unlike chemical drugs, molecular identity cannot generally be established for any two biological drugs. Accordingly, their pharmacological properties cannot be assumed to be the same...
February 8, 2018: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/29422802/efficacy-and-safety-of-the-adalimumab-biosimilar-exemptia-as-induction-therapy-in-moderate-to-severe-ulcerative-colitis
#5
Vandana Midha, Ramit Mahajan, Varun Mehta, Vikram Narang, Arshdeep Singh, Kirandeep Kaur, Ajit Sood
Background/Aims: Data on the efficacy and safety of the adalimumab biosimilar Exemptia are limited. Methods: Patients with moderate-to-severe active steroid-refractory ulcerative colitis (UC) treated at Dayanand Medical College and Hospital, India were offered cyclosporine A, biologicals or biosimilars, or surgery. A retrospective analysis was conducted on patients who were treated with the adalimumab biosimilar, Exemptia. These patients were administered an induction dosing schedule of 160 mg Exemptia at week 0, 80 mg at week 2, and then 40 mg every other week from week 4 to 8...
January 2018: Intestinal Research
https://www.readbyqxmd.com/read/29417431/epoetin-biosimilars-in-the-treatment-of-chemotherapy-induced-anemia-10%C3%A2-years-experience-gained
#6
REVIEW
Matti Aapro, Andriy Krendyukov, Martin Schiestl, Pere Gascón
High-quality, safe, and effective biosimilars have the potential to increase access to biological therapies worldwide and to reduce cancer care costs. The European Medicines Agency (EMA) was the first regulatory authority to establish legislative procedures for the approval of biosimilars when they published their guidelines on similar biological medicinal products in 2005. Biosimilar epoetins were first approved in 2007, and a wealth of data has been collected over the last decade. Two biosimilar epoetins (under five commercial names) have been approved by the EMA so far...
February 7, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29415440/revisiting-the-therapeutic-potential-of-bothrops-jararaca-venom-screening-for-novel-activities-using-connectivity-mapping
#7
Carolina Alves Nicolau, Alyson Prorock, Yongde Bao, Ana Gisele da Costa Neves-Ferreira, Richard Hemmi Valente, Jay William Fox
Snake venoms are sources of molecules with proven and potential therapeutic applications. However, most activities assayed in venoms (or their components) are of hemorrhagic, hypotensive, edematogenic, neurotoxic or myotoxic natures. Thus, other relevant activities might remain unknown. Using functional genomics coupled to the connectivity map (C-map) approach, we undertook a wide range indirect search for biological activities within the venom of the South American pit viper Bothrops jararaca . For that effect, venom was incubated with human breast adenocarcinoma cell line (MCF7) followed by RNA extraction and gene expression analysis...
February 6, 2018: Toxins
https://www.readbyqxmd.com/read/29411547/the-science-behind-biosimilars-entering-a-new-era-of-biologic-therapy
#8
S Louis Bridges, Douglas W White, Angus B Worthing, Ellen M Gravallese, James R O'Dell, Kamala Nola, Jonathan Kay, Stanley B Cohen
No abstract text is available yet for this article.
February 7, 2018: Arthritis & Rheumatology
https://www.readbyqxmd.com/read/29411318/policy-options-for-infliximab-biosimilars-in-inflammatory-bowel-disease-given-emerging-evidence-for-switching
#9
Don Husereau, Brian Feagan, Carl Selya-Hammer
Biosimilars are becoming increasingly available internationally as patents expire on the originator biologic drugs they are intended to copy. Although substitution policies seen with generic drugs are being considered as a means to reduce expenditures on biologics, some biosimilars pose particular challenges in that the act of substitution may eventually lead to increased rates of therapeutic failure. As evidence requirements from regulators do not directly address this challenge, switch trials of biosimilars have emerged that may provide further answers...
February 6, 2018: Applied Health Economics and Health Policy
https://www.readbyqxmd.com/read/29411222/physicochemical-characterization-glycosylation-pattern-and-biosimilarity-assessment-of-the-fusion-protein-etanercept
#10
Othman Montacir, Houda Montacir, Andreas Springer, Stephan Hinderlich, Fereidoun Mahboudi, Amirhossein Saadati, Maria Kristina Parr
Etanercept is a soluble fusion protein of the tumor necrosis factor receptor (TNFR) extracellular domain, linked to an Fc part of IgG1. It possesses three N- and 13 O-glycosylation sites. Due to its complex structure, an analytical challenge is facing the development and approval of biosimilars. In the current study, physicochemical characterization using state-of-the-art analytics was performed to analyze intact and subunit masses, post-translational modifications (PTMs), higher order structure and potency of Etanercept originator Enbrel® and its biosimilar Altebrel™ (AryoGen Pharmed) in accordance to critical quality attributes of biopharmaceuticals...
February 6, 2018: Protein Journal
https://www.readbyqxmd.com/read/29411181/biosimilars-in-rheumatology-recommendations-for-regulation-and-use-in-middle-eastern-countries
#11
Bassel El Zorkany, Nizar Al Ani, Samar Al Emadi, Jamal Al Saleh, Imad Uthman, Yasser El Dershaby, Mohamed Mounir, Hani Al Moallim
The increasing availability of biosimilar medicines in Middle Eastern regions may provide an opportunity to increase the number of rheumatology patients who have access to traditionally more expensive biologic medicines. However, as well as a lack of real-world data on the use of biosimilar medicines in practice, the availability of intended copies in the region may undermine physician confidence in prescribing legitimate biosimilar medicines. There is a need for regional recommendations for healthcare professionals to ensure that biosimilar drugs can be used safely...
February 6, 2018: Clinical Rheumatology
https://www.readbyqxmd.com/read/29408510/structure-function-relationships-for-recombinant-erythropoietins-a-case-study-from-a-proposed-manufacturing-change-with-implications-for-erythropoietin-biosimilar-study-designs
#12
Gustavo Grampp, Patricia L McElroy, Gary Camblin, Allan Pollock
Comparability studies used to assess a proposed manufacturing change for a biological product include sensitive analytical studies to confirm there are no significant differences in structural or functional attributes that may contribute to clinically meaningful changes in efficacy or safety. When a proposed change is relatively complex or when clinically relevant differences between the product before and after the change cannot be ruled out based on analytical studies, nonclinical and clinical bridging studies are generally required to confirm overall comparability...
January 31, 2018: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29368288/ly2963016-insulin-glargine-a-review-in-type-1-and-2-diabetes
#13
Yvette N Lamb, Yahiya Y Syed
Subcutaneous once-daily LY2963016 insulin glargine (LY insulin glargine) [Abasaglar® (EU); Basaglar® (USA)] has been approved in the EU as a biosimilar to reference insulin glargine (Lantus®), and in the USA as a follow-on biologic to reference insulin glargine, for use in patients with type 1 or 2 diabetes. Structural and functional characterization of LY insulin glargine in preclinical studies showed that it is similar to reference insulin glargine. In phase I euglycaemic clamp studies, LY insulin glargine demonstrated similar pharmacodynamic (including duration of action) and pharmacokinetic parameters to reference insulin glargine...
January 24, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29368188/the-nocebo-effect-challenges-the-non-medical-infliximab-switch-in-practice
#14
N W Boone, L Liu, M J Romberg-Camps, L Duijsens, C Houwen, P H M van der Kuy, R Janknegt, R Peeters, R B M Landewé, B Winkens, A A van Bodegraven
BACKGROUND: In clinical practice, non-medical switching of biological medication may provoke nocebo effects due to unexplained deterioration of therapeutic benefits. Indication extrapolation, idiosyncratic reactions, and interchangeability remain challenged in clinical practice after biosimilar approval by the European Medicines Agency. The principle of "first do no harm" may be challenged in a patient when switching from originator to biosimilar biological. AIM: To describe the 1-year results of a pragmatic study on infliximab biosimilar implementation in immune-mediated inflammatory disease patients on the basis of shared decision-making under effectiveness and safety monitoring...
January 24, 2018: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29364594/biosimilars-in-dermatology-theory-becomes-reality
#15
REVIEW
Sascha Gerdes, Ulrich Mrowietz, Matthias Augustin, Ralph von Kiedrowski, Alexander Enk, Klaus Strömer, Michael P Schön, Marc A Radtke
Biosimilars are biological medicines that are analogues of a specific reference product. Biosimilars of the tumor necrosis factor alpha inhibitors infliximab and etanercept are already approved and available for dermatological indications. Regulatory agencies require in-depth analysis of physicochemical and functional properties of these highly complex molecules as well as clinical data on their similarity regarding efficacy and safety in at least one clinical trial in a sensitive and homogeneous population...
January 24, 2018: Journal der Deutschen Dermatologischen Gesellschaft, Journal of the German Society of Dermatology: JDDG
https://www.readbyqxmd.com/read/29360210/biosimilars-what-the-dermatologist-should-know
#16
REVIEW
Paul Yamauchi, Jeffrey Crowley, Primal Kaur, Lynda Spelman, Richard Warren
Biosimilars are highly similar versions of approved branded biologics. In contrast to generics, which are identical copies of the originator medicines, biosimilars are considered unique but related molecules that differ from the originator reference product as well as from each other. Owing to the complexity of biologic medicines, such as therapeutic monoclonal antibodies, minor differences between biosimilars and the reference products are acceptable provided these differences do not result in any clinically meaningful differences in safety or efficacy...
January 23, 2018: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/29351237/bioengineering-of-rfviia-biopharmaceutical-and-structure-characterization-for-biosimilarity-assessment
#17
Othman Montacir, Houda Montacir, Murat Eravci, Andreas Springer, Stephan Hinderlich, Fereidoun Mahboudi, Amirhossein Saadati, Maria Kristina Parr
Eptacog alfa (NovoSeven®) is a vitamin K-dependent recombinant Factor VIIa produced by genetic engineering from baby hamster kidney (BHK) cells as a single peptide chain of 406 residues. After activation, it consists of a light chain (LC) of 152 amino and a heavy chain (HC) of 254 amino acids. Recombinant FVIIa undergoes many post-translational modifications (PTMs). The first ten glutamic acids of the N-terminal moiety are γ-carboxylated, Asn145 and Asn322 are N-glycosylated, and Ser52 and Ser60 are O-glycosylated...
January 19, 2018: Bioengineering
https://www.readbyqxmd.com/read/29350568/abp-980-promising-trastuzumab-biosimilar-for-her2-positive-breast-cancer
#18
Elisavet Paplomata, Rita Nahta
Approval of the HER2-targeted antibody trastuzumab dramatically improved outcomes for patients with HER2-positive breast cancer. Multiple trastuzumab biosimilars, including ABP 980, are in clinical development. Biosimilars are not identical to the reference biologic, but exhibit equivalence and safety in analytical and clinical studies. Areas covered: A brief introduction to trastuzumab, overview of trastuzumab biosimilars, and detailed review of ABP 980 preclinical and clinical studies are included. We searched PubMed and 2016-2017 ASCO and ESMO conference proceedings for "ABP 980" or "trastuzumab biosimilar"...
January 19, 2018: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/29350566/abp-501-for-the-treatment-of-rheumatoid-arthritis
#19
Eleftherios Pelechas, Paraskevi V Voulgari, Alexandros A Drosos
Rheumatoid arthritis (RA) is an autoimmune disease, which has a negative impact on the ability to perform activities daily. Tumour necrosis factor α (TNF) is a cytokine with diverse cellular effects, and a key regulator of the inflammatory response. ABP 501 is a biosimilar to adalimumab, a TNF inhibitor. Areas covered: In this review, we examined ABP 501, as a biosimilar candidate to adalimumab in the treatment of RA focusing on the available data. Current data indicate that ABP 501 is a highly similar alternative to adalimumab in terms of safety, efficacy, tolerability and immunogenicity...
January 19, 2018: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/29349829/physicians-perspective-on-the-clinical-meaningfulness-of-inflammatory-bowel-disease-trial-results-an-international-organization-for-the-study-of-inflammatory-bowel-disease-ioibd-survey
#20
P Olivera, W J Sandborn, J Panés, C Baumann, G D'Haens, S Vermeire, S Danese, L Peyrin-Biroulet
BACKGROUND: Several novel compounds are being developed for inflammatory bowel diseases (IBD). In addition, biosimilar drugs are being approved. An increasing number of head-to-head, superiority and non-inferiority trials in patients with IBD are expected in the future. The clinical relevance of the magnitude of the effect size is often debated. AIM: To better understand physicians' perspectives on the clinical meaningfulness of IBD trial results. METHODS: We conducted an online survey among all IOIBD (International Organization for the Study of Inflammatory Bowel Diseases) members, asking their opinion on the clinical relevance of the results of IBD trials...
January 19, 2018: Alimentary Pharmacology & Therapeutics
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