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BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy

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https://read.qxmd.com/read/30747341/in-use-stability-of-the-rituximab-biosimilar-ct-p10-truxima-%C3%A2-following-preparation-for-intravenous-infusion-and-storage
#1
Su Jung Kim, Kwang Woo Kim, Yeon Kyeong Shin, Ji Woong Kwon, Hye Young Kang, Yoon A Park, Ji Young Shin, So Young Kim, Won Yong Han
BACKGROUND: CT-P10 is the first biosimilar of the anti-CD20 monoclonal antibody, rituximab. CT-P10 is currently available in over 51 countries worldwide, where it is approved in the same indications as its reference product rituximab. In-use stability studies are conducted for biologics to determine how conditions (e.g., temperature, light, humidity, length of time stored) affect drug quality following dilution and storage in infusion bags. OBJECTIVE: We evaluated the in-use stability of CT-P10 for intravenous infusion stored diluted in infusion bags over longer periods than currently recommended by manufacturer guidelines...
February 11, 2019: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/30712241/fkb327-an-adalimumab-biosimilar
#2
Zaina T Al-Salama
FKB327 (Hulio® ) is a biosimilar of the reference monoclonal anti-TNFα antibody adalimumab, and is approved in the EU for use in the same indications as reference adalimumab. FKB327 has similar physicochemical and pharmacodynamic properties to those of reference adalimumab, and pharmacokinetic equivalence was shown in healthy volunteers and patients with moderate-to-severe rheumatoid arthritis (RA) despite methotrexate therapy. FKB327 demonstrated equivalent clinical efficacy to that of reference adalimumab in patients with moderate-to-severe RA, and similar tolerability, safety and immunogenicity profiles...
February 2, 2019: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/30701419/pegfilgrastim-jmdb-myl-1401h-a-pegfilgrastim-biosimilar
#3
Sheridan M Hoy
Pegfilgrastim-jmdb/MYL-1401H (FULPHILA™) [hereafter referred to as pegfilgrastim-jmdb] is a biosimilar of the reference pegylated recombinant granulocyte colony-stimulating factor pegfilgrastim. It is approved for use in patients receiving chemotherapy for malignancy to decrease the incidence of infection, as manifested by febrile neutropenia, in the USA and to reduce the duration of neutropenia and the incidence of febrile neutropenia in the EU. Pegfilgrastim-jmdb has similar physicochemical characteristics and functional properties to those of US- and EU-sourced reference pegfilgrastim, and the pharmacodynamic and pharmacokinetic similarity of the agents has also been demonstrated in healthy volunteers...
January 30, 2019: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/30701418/selective-jakinibs-prospects-in-inflammatory-and-autoimmune-diseases
#4
REVIEW
Anniina T Virtanen, Teemu Haikarainen, Juuli Raivola, Olli Silvennoinen
Cytokines, many of which signal through the JAK-STAT (Janus kinase-Signal Transducers and Activators of Transcription) pathway, play a central role in the pathogenesis of inflammatory and autoimmune diseases. Currently three JAK inhibitors have been approved for clinical use in USA and/or Europe: tofacitinib for rheumatoid arthritis, psoriatic arthritis and ulcerative colitis, baricitinib for rheumatoid arthritis, and ruxolitinib for myeloproliferative neoplasms. The clinical JAK inhibitors target multiple JAKs at high potency and current research has focused on more selective JAK inhibitors, almost a dozen of which currently are being evaluated in clinical trials...
January 30, 2019: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/30604391/comment-on-the-end-of-phase-3-clinical-trials-in-biosimilars-development
#5
LETTER
Sarfaraz K Niazi
No abstract text is available yet for this article.
January 2, 2019: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/30604390/monoclonal-antibodies-for-multiple-sclerosis-an-update
#6
REVIEW
Jonas Graf, Orhan Aktas, Konrad Rejdak, Hans-Peter Hartung
The use of monoclonal antibodies in multiple sclerosis (MS) patients is in a transitional period. Studies regarding well-established, effective antibodies such as natalizumab and alemtuzumab focus more and more on long-term efficacy and safety, risk management, and treating complications. Primary progressive MS, a disease that was long considered to be unmodifiable, is currently in focus following ocrelizumab being approved as the first drug with a proven beneficial effect on the disease course. Conversely, post-marketing safety mechanisms have also proven to function as daclizumab has been suspended after a series of relevant serious adverse events...
January 2, 2019: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/30604389/current-ebola-virus-vaccine-progress
#7
Andrea Marzi, Chad E Mire
Over 40 years since the discovery of Ebola virus, the anti-Ebola virus vaccine efforts of the past 2 decades have culminated in over 12 different vaccine candidates that have been placed into a number of clinical trial phases, past and present. Of these 12 vaccines, four candidates are up to or in phase II clinical trials, and only one has completed the phase III clinical trial stage. While remarkable progress toward a national regulatory agency-approved vaccine for Ebola virus has been made, there remain unanswered questions on issues such as, but not limited to, vaccine protective immunity and duration of that immunity, and the appropriate vaccination strategy for those at risk of Ebola virus infection...
January 2, 2019: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/30604388/the-impact-of-the-fecal-microbiome-on-cancer-immunotherapy
#8
Afaf E G Osman, Jason J Luke
Recent advances in culture-free methods of studying the human microbiome, coupled with strong bioinformatics tools, have provided new insights on the role of the human microbiome in health and disease. The human gut, in particular, houses a vast number and diverse variety of microbes. A plethora of evidence has demonstrated the significant effects of the gut microbiome on local and systemic immunity. Studies in hematopoietic stem cell transplantation recipients provided early evidence of the involvement of the gut microbiome in the development of graft-versus-host disease and its related mortality...
January 2, 2019: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/30560413/mechanisms-and-management-of-chimeric-antigen-receptor-t-cell-therapy-related-toxicities
#9
REVIEW
Bhagirathbhai R Dholaria, Christina A Bachmeier, Frederick Locke
Chimeric antigen receptor T-cell (CAR-T) therapy has proven to be a very effective cancer immunotherapy. Axicabtagene ciloleucel and tisagenlecleucel are the first-in-class anti-CD19 CAR-T currently available for relapsed/refractory adult large B-cell lymphoma. Tisagenlecleucel is also available for pediatric and young adult (up to age 25 years) patients with relapsed/refractory B-acute lymphoblastic leukemia. Cytokine release syndrome (CRS) and CAR-T-associated encephalopathy syndrome (neurotoxicity) are the most common adverse effects associated with CAR-T therapy...
December 17, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/30539362/lanadelumab-for-the-prophylactic-treatment-of-hereditary-angioedema-with-c1-inhibitor-deficiency-a-review-of-preclinical-and-phase-i-studies
#10
REVIEW
Paula J Busse, Henriette Farkas, Aleena Banerji, William R Lumry, Hilary J Longhurst, Daniel J Sexton, Marc A Riedl
Hereditary angioedema (HAE) with C1 esterase inhibitor (C1-INH) deficiency (C1-INH-HAE) is a rare disease characterized by diminished levels or dysfunctional activity of C1-INH, leading to dysregulated plasma kallikrein activity within the kallikrein-kinin pathway. Symptoms manifest as painful, potentially life-threatening swelling of subcutaneous tissues throughout the body and/or submucosal edema in the upper airway or gastrointestinal tract. Attacks recur with unpredictable frequency, intensity, and duration, placing a heavy burden on patients' daily lives...
December 12, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/30511316/a-phase-i-study-comparing-the-pharmacokinetics-safety-and-immunogenicity-of-proposed-biosimilar-gb242-and-reference-infliximab-in-healthy-subjects
#11
Tan Zhang, Guihong Chen, Chang Liu, Li'an Zu, Qi Wang, Yitong Wang, Jie Lv, Youzhong An, Lihou Dong, Huiyang Cheng, Shengbin Ren, Qian Wang, Qingshan Zheng, Haifeng Song, Yi Fang
OBJECTIVE: The objective of this study was to compare the pharmacokinetics (PKs), safety, and immunogenicity of GB242 as a potential biosimilar infliximab with those of reference infliximab in healthy Chinese subjects. METHODS: We conducted a randomized, single-center, double-blind, parallel-controlled phase I study in which 48 healthy subjects were divided equally into a GB242 group and reference infliximab group. Both the test and reference drug were administered as a single intravenous dose of 3 mg/kg...
December 3, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/30506495/comparison-of-the-pharmacokinetic-pharmacodynamic-relationships-of-two-darbepoetin-alfa-formulations-in-healthy-male-volunteers
#12
Seokuee Kim, Taegon Hong, Jae-Wook Ko, Wooseong Huh, Jung-Ryul Kim
OBJECTIVE: This study compared the pharmacokinetic (PK), pharmacodynamic (PD), and safety properties of the test (CJ-40001) and reference (NESP® ) versions of darbepoetin alfa following a single subcutaneous (SC) or intravenous (IV) administration in healthy male subjects. METHODS: A single-blind, randomized, single-dose, two-period, two-intervention crossover study was conducted, with two separate parts consisting of SC or IV administration. In each period, either a test or reference product was administered via the SC or IV route...
December 1, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/30499082/comparative-effectiveness-and-safety-of-monoclonal-antibodies-bevacizumab-cetuximab-and-panitumumab-in-combination-with-chemotherapy-for-metastatic-colorectal-cancer-a-systematic-review-and-meta-analysis
#13
REVIEW
Wânia Cristina da Silva, Vânia Eloisa de Araujo, Ellias Magalhães E Abreu Lima, Jessica Barreto Ribeiro Dos Santos, Michael Ruberson Ribeiro da Silva, Paulo Henrique Ribeiro Fernandes Almeida, Francisco de Assis Acurcio, Brian Godman, Amanj Kurdi, Mariângela Leal Cherchiglia, Eli Iola Gurgel Andrade
BACKGROUND: The last decade has seen the increasing use of biological medicines in combination with chemotherapy containing 5-fluorouracil/oxaliplatin or irinotecan for the treatment of metastatic colorectal cancer (mCRC). These combinations have resulted in increased progression-free survival (PFS) in patients with mCRC; however, there are remaining concerns over the extent of their effect on overall survival (OS). Published studies to date suggest no major differences between the three currently available monoclonal antibodies (MoAbs); however, there are differences in costs...
November 30, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/30499081/recombinant-antibody-production-in-cho-and-ns0-cells-differences-and-similarities
#14
REVIEW
Venkata Gayatri Dhara, Harnish Mukesh Naik, Natalia I Majewska, Michael J Betenbaugh
The commercial production of monoclonal antibodies (mAbs) has revolutionized the treatment of many diseases, including cancer, multiple sclerosis, and rheumatoid arthritis. These biotherapeutics have the potential to generate a global annual revenue of more than US$150 billion. Two cell hosts are predominantly utilized to produce these mAbs: Chinese hamster ovary (CHO) cells and murine myeloma cells (NS0). By 2017, nearly one-quarter of all approved mAbs in the market were produced using the NS0 host cell line, and around two-thirds were produced in CHO cells...
November 30, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/30719632/long-term-efficacy-and-safety-of-biosimilar-ct-p10-versus-innovator-rituximab-in-rheumatoid-arthritis-48-week-results-from-a-randomized-phase-iii-trial
#15
Chang-Hee Suh, Dae Hyun Yoo, Alfredo Berrocal Kasay, Elia Chalouhi El-Khouri, Francisco Fidenci Cons Molina, Pavel Shesternya, Pedro Miranda, Francisco G Medina-Rodriguez, Piotr Wiland, Slawomir Jeka, Jose Chavez-Corrales, Thomas Linde, Pawel Hrycaj, Mauricio Abello-Banfi, Ihor Hospodarskyy, Janusz Jaworski, Mariusz Piotrowski, Marek Brzosko, Marek Krogulec, Sergii Shevchuk, Armando Calvo, Daina Andersone, Won Park, Seung Cheol Shim, Sang Joon Lee, Sung Young Lee
OBJECTIVE: The aim of this study was to investigate long-term clinical outcomes of extended treatment with CT-P10, a rituximab biosimilar, compared with rituximab reference products sourced from the USA and the EU (US-RTX and EU-RTX) in rheumatoid arthritis (RA) for up to 48 weeks. METHODS: In this multinational, randomized, double-blind trial, adults with active RA received up to two courses of CT-P10, US-RTX, or EU-RTX alongside methotrexate. Efficacy endpoints included Disease Activity Score 28-joint count (DAS28) and American College of Rheumatology (ACR) response rates...
February 2019: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/30488231/targeting-il-6-or-il-6-receptor-in-rheumatoid-arthritis-what-s-the-difference
#16
Ali Berkant Avci, Eugen Feist, Gerd Rüdiger Burmester
Interleukin-6 (IL-6) signaling is a critical target in inflammatory pathways. Today, tocilizumab (TCZ) and sarilumab (SAR), two IL-6 receptor-inhibiting monoclonal antibodies, are widely used in the treatment of rheumatoid arthritis (RA), with a favorable efficacy/safety profile. Successful introduction of such agents in the treatment of RA has encouraged the development of other agents targeting different points of the pathway. Sirukumab (SRK), a human anti-IL-6 monoclonal antibody, has been evaluated in clinical trials and showed largely similar clinical efficacy compared with TCZ and other IL-6 pathway-targeting agents...
December 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/30460599/gp2017-an-adalimumab-biosimilar
#17
Young-A Heo
GP2017 (adalimumab) is a biosimilar anti-TNF-α antibody. It is approved in the EU for use in all indications for which reference adalimumab is approved. GP2017 has similar physicochemical and functional properties to those of reference adalimumab, and the pharmacokinetic similarity of the agent has been shown in healthy male volunteers. GP2017 demonstrated clinical efficacy equivalent to that of reference adalimumab in patients with moderate to severe plaque psoriasis or rheumatoid arthritis; the tolerability, safety and immunogenicity profiles of the two agents were also similar...
November 20, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/30443849/correction-to-pf-06438179-gp1111-an-infliximab-biosimilar
#18
Zaina T Al-Salama
The article PF-06438179/GP1111: An Infliximab Biosimilar, written by Zaina T. Al-Salama.
November 15, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/30430367/bispecific-antibody-emicizumab-for-haemophilia-a-a-breakthrough-for-patients-with-inhibitors
#19
Johnny N Mahlangu
Current unmet needs in haemophilia A patients with inhibitors include the need for intravenous infusion of replacement therapy and the high burden of treatment associated with prophylaxis. Emicizumab is a humanised bispecific monoclonal antibody designed to address these unmet needs and has completed phase III clinical trials in adolescents/adults (HAVEN 1) and paediatric (HAVEN 2) inhibitor populations. In HAVEN 1, there was an 80% bleed reduction across all bleeds, 89% reduction in treated joint bleeds, 92% reduction in treated spontaneous bleeds, and 95% reduction in treated target joint bleeds on emicizumab compared with no prophylaxis...
November 14, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/30386977/in-use-physicochemical-and-biological-stability-of-the-trastuzumab-biosimilar-ct-p6-upon-preparation-for-intravenous-infusion
#20
Su Jung Kim, Joon Won Lee, Hye Young Kang, So Young Kim, Yeon Kyeong Shin, Kwang Woo Kim, Jun Seok Oh, Ki Jung Lim, Ji Young Kim
BACKGROUND: CT-P6 is a biosimilar of trastuzumab, a monoclonal antibody targeting human epidermal growth factor 2 (HER2), that is used in the treatment of breast and gastric cancers. OBJECTIVE: The aim of this study was to evaluate the in-use physicochemical and biological stability of CT-P6 following preparation for intravenous (IV) infusion. METHODS: One batch of CT-P6 within the final month of its 48-month shelf life was used to simulate sub-optimal administration conditions...
November 2, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
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