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Cell-Based Assays to Detect Innate Immune Response Modulating Impurities: Application to Biosimilar Insulin.
AAPS J
December 2024
Laboratory of Immunology, Office of Pharmaceutical Quality Research Division-IV, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA.
Characterizing and mitigating factors that impact product immunogenicity can aid in risk assessment and/or managing risk following manufacturing changes. For follow-on products that have the same indication, patient population, and active product ingredient, the residual immunogenicity risk resides predominantly on differences in product and process related impurities. Characterizing differences in innate immune modulating impurities (IIRMI), which could act as adjuvants by activating local antigen presenting cells (APCs), can inform the immunogenicity risk assessment potentially reducing the need for clinical trials.
View Article and Find Full Text PDFAssessing Functional Similarity of Biosimilar ABP 654 and Ustekinumab in Samples from Patients with Crohn's Disease.
J Inflamm Res
December 2024
Biosimilar Process Development, Amgen Inc., Thousand Oaks, CA, 91320, USA.
Purpose: ABP 654 is the first FDA-approved interchangeable biosimilar for ustekinumab reference product (RP). To support the totality of evidence (TOE), in vitro pharmacology studies were conducted in peripheral blood mononuclear cells (PBMCs) from healthy human donors and Crohn's disease (CD) patients to evaluate IL-23 and IL-12 inhibition by ABP 654 and ustekinumab RP relevant to the mechanism of action of chronic inflammation.
Methods: ABP 654 and ustekinumab RP were assessed using inhibition of IL-23 and IL-12-mediated IFN-γ release, signal transducer and activator of transcription (STAT)3 and STAT4 phosphorylation, and IL-17 release.
Efficacy and Safety of Bevacizumab Biosimilar (Encoda) Compared With Reference Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer: A Multicenter, Real-World Study.
Clin Med Insights Oncol
December 2024
Department of Pharmacy, Fudan University Shanghai Cancer Center, Shanghai, China.
Background: The bevacizumab biosimilar (Encoda), which was approved by the National Medical Products Administration (NMPA) in China in 2019, is a biosimilar of bevacizumab. Approval of bevacizumab biosimilar (Encoda) for metastatic colorectal cancer (mCRC) was based on the extrapolation principle of biosimilar. However, there is currently no available data regarding the efficacy and safety of both bevacizumab biosimilar (Encoda) and bevacizumab in patients with mCRC.
View Article and Find Full Text PDFAdvice to the FDA to Improve Its Proposed Guidelines to Rationalize Clinical Trials by Restricting Placebo Control, Preventing Low-Powered Studies, and Disallowing Studies Where Bioavailability Is Not Proven.
Pharmaceuticals (Basel)
October 2024
College of Pharmacy, University of Illinois, Chicago, IL 60612, USA.
Randomized controlled trials (RCTs) are the gold standard for testing the safety and efficacy of new drugs and biologicals. The US Food and Drug Administration (FDA) has proactively improved the trial designs to make them scientifically rational while avoiding unnecessary human exposure. Several new guidelines by the FDA have come in 2024 that address consolidating the RCTs with the Real-World Evidence (RWE) trials, decentralizing the testing platforms, and allowing the point-of-use clinicians to participate.
View Article and Find Full Text PDFPlacebo Effects: Neurological Mechanisms Inducing Physiological, Organic, and Belief Responses-A Prospective Analysis.
Healthcare (Basel)
November 2024
College of Pharmacy, University of Illinois, Chicago, IL 60612, USA.
The placebo effect can induce physiological or clinical neurological and organic responses despite the recipient receiving no active ingredients; these responses are based instead on the recipient's perceptions. Placebo effects come from the rostral anterior cingulate cortex, pontine nucleus, and cerebellum of the brain; this information provides a better understanding of placebo effects and can also help us understand the mechanism of the modulation of neurotransmitters from the use of psychedelic substances, activity of selective serotonin reuptake inhibitors, the process of transcranial magnetic stimulation, and deep brain stimulation, as well as aid in developing novel therapies, challenging the validity of controlled clinical trials (RCTs) that the regulatory agencies now appreciate. Education about how placebo effects bring in social, political, and religious beliefs and whether these can be modulated may help reduce global confrontations.
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