Six-Year Survival Outcomes for Patients with HER2-Positive Early Breast Cancer Treated with CT-P6 or Reference Trastuzumab: Observational Follow-Up Study of a Phase 3 Randomised Controlled Trial
ConclusionsData from this extended follow-up of the CT-P6 3.2 study demonstrate the comparable long-term efficacy of CT-P6 and reference trastuzumab up to 6 years.EudraCT number2019-003518-15 (retrospectively registered 10 March 2020). (Source: BioDrugs)
Source: BioDrugs - March 7, 2023 Category: Drugs & Pharmacology Source Type: research
Correction to: Understanding US Physician and Pharmacist Attitudes Toward Biosimilar Products: A Qualitative Study
(Source: BioDrugs)
Source: BioDrugs - March 7, 2023 Category: Drugs & Pharmacology Source Type: research
Six-Year Survival Outcomes for Patients with HER2-Positive Early Breast Cancer Treated with CT-P6 or Reference Trastuzumab: Observational Follow-Up Study of a Phase 3 Randomised Controlled Trial
ConclusionsData from this extended follow-up of the CT-P6 3.2 study demonstrate the comparable long-term efficacy of CT-P6 and reference trastuzumab up to 6 years.EudraCT number2019-003518-15 (retrospectively registered 10 March 2020). (Source: BioDrugs)
Source: BioDrugs - March 7, 2023 Category: Drugs & Pharmacology Source Type: research
Correction to: Understanding US Physician and Pharmacist Attitudes Toward Biosimilar Products: A Qualitative Study
(Source: BioDrugs)
Source: BioDrugs - March 7, 2023 Category: Drugs & Pharmacology Source Type: research
Severe Hypersensitivity Reactions at Biosimilar versus Originator Rituximab Treatment Initiation, Switch and Over Time: A Cohort Study on the French National Health Data System
ConclusionOur study does not support any association between exposure to rituximab biosimilars versus originator and hospitalization for a hypersensitivity reaction, either at initiation, at switch, or over time. (Source: BioDrugs)
Source: BioDrugs - March 6, 2023 Category: Drugs & Pharmacology Source Type: research
Targeting IL-36 in Inflammatory Skin Diseases
AbstractInterleukin (IL)-36 cytokines are members of the IL-1 superfamily of cytokines. IL-36 cytokines are composed of three agonists (IL-36 α, IL-36β, and IL-36γ) and two antagonists (IL-36 receptor antagonist [IL36Ra] and IL-38). These work in innate and acquired immunity and are known to contribute to host defense and to the pathogenesis of autoinflammatory diseases, autoimmune diseases, and infectious diseases. In the skin, IL-36α and IL-36γ are mainly expressed by keratinocytes in the epidermis, although they are also produced by dendritic cells, macrophages, endothelial cells, and dermal fibroblasts. IL-36 cyto...
Source: BioDrugs - March 3, 2023 Category: Drugs & Pharmacology Source Type: research
Immunogenicity of Recombinant Adeno-Associated Virus (AAV) Vectors for Gene Transfer
AbstractRecombinant adeno-associated viruses (AAVs) have emerged as promising gene delivery vehicles resulting in three US Food and Drug Administration (FDA) and one European Medicines Agency (EMA)-approved AAV-based gene therapies. Despite being a leading platform for therapeutic gene transfer in several clinical trials, host immune responses against the AAV vector and transgene have hampered their widespread application. Multiple factors, including vector design, dose, and route of administration, contribute to the overall immunogenicity of AAVs. The immune responses against the AAV capsid and transgene involve an initia...
Source: BioDrugs - March 2, 2023 Category: Drugs & Pharmacology Source Type: research
Serplulimab Plus Chemotherapy vs Chemotherapy for Treatment of US and Chinese Patients with Extensive-Stage Small-Cell Lung Cancer: A Cost-Effectiveness Analysis to Inform Drug Pricing
ConclusionsSerplulimab might be a valuable and cost-effective therapy in both the US and China. The evidence-based pricing strategy provided by this study could benefit decision-makers in making optimal decisions and clinicians in general clinical practice. More evidence about the budget impact and affordability for patients is needed. (Source: BioDrugs)
Source: BioDrugs - February 25, 2023 Category: Drugs & Pharmacology Source Type: research
Efficacy and Safety of Denosumab Biosimilar QL1206 Versus Denosumab in Patients with Bone Metastases from Solid Tumors: A Randomized Phase III Trial
ConclusionsDenosumab biosimilar QL1206 had promising efficacy, tolerable safety, and pharmacokinetics equivalent to denosumab and could benefit patients with bone metastases from solid tumors.Clinical Trial RegistrationClinicalTrials.gov Identifier: NCT04550949, retrospectively registered on 16 September, 2020 (Source: BioDrugs)
Source: BioDrugs - February 21, 2023 Category: Drugs & Pharmacology Source Type: research
