Osman, Afaf E. G. Luke, Jason J.
Published in
BioDrugs
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 ...
Graf, Jonas Aktas, Orhan Rejdak, Konrad Hartung, Hans-Peter
Published in
BioDrugs
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 t...
Busse, Paula J. Farkas, Henriette Banerji, Aleena Lumry, William R. Longhurst, Hilary J. Sexton, Daniel J. Riedl, Marc A.
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BioDrugs
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 ...
Zhang, Tan Chen, Guihong Liu, Chang Zu, Li’an Wang, Qi Wang, Yitong Lv, Jie An, Youzhong Dong, Lihou Cheng, Huiyang
...
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BioDrugs
ObjectiveThe 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.MethodsWe conducted a randomized, single-center, double-blind, parallel-controlled phase I study in which 48 healthy subjects were div...
Stanimirovic, Danica B. Sandhu, Jagdeep K. Costain, Will J.
Published in
BioDrugs
Antibody, immuno- and gene therapies developed for neurological indications face a delivery challenge posed by various anatomical and physiological barriers within the central nervous system (CNS); most notably, the blood–brain barrier (BBB). Emerging delivery technologies for biotherapeutics have focused on trans-cellular pathways across the BBB u...
da Silva, Wânia Cristina de Araujo, Vânia Eloisa Lima, Ellias Magalhães e Abreu dos Santos, Jessica Barreto Ribeiro Silva, Michael Ruberson Ribeiro da Almeida, Paulo Henrique Ribeiro Fernande... de Assis Acurcio, Francisco Godman, Brian Kurdi, Amanj Cherchiglia, Mariângela Leal
...
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BioDrugs
BackgroundThe 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...
Al-Salama, Zaina T.
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BioDrugs
PF-06438179/GP1111 (Zessly®; Ixifi®) [hereafter referred to as GP1111] is a biosimilar of the reference monoclonal anti-TNF-α antibody infliximab, and is approved in the EU and USA for the same indications as the reference drug, including rheumatoid arthritis (RA), Crohn’s disease, ulcerative colitis (including paediatric ulcerative colitis in the ...
Dhara, Venkata Gayatri Naik, Harnish Mukesh Majewska, Natalia I. Betenbaugh, Michael J.
Published in
BioDrugs
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: Chines...
Kim, Seokuee Hong, Taegon Ko, Jae-Wook Huh, Wooseong Kim, Jung-Ryul
Published in
BioDrugs
ObjectiveThis 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.MethodsA single-blind, randomized, single-dose, two-period, two-intervention cro...
Avci, Ali Berkant Feist, Eugen Burmester, Gerd Rüdiger
Published in
BioDrugs
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 enc...