Cargando…

Meta‐analysis of Pharmacokinetic/Pharmacodynamic Results of 3 Phase 1 Studies with Biosimilar Pegfilgrastim

A meta‐analysis using data from 3 phase 1 studies evaluated the pharmacokinetics (PK) and pharmacodynamics (PD) of Sandoz biosimilar versus US‐ and EU‐reference pegfilgrastim. The studies included a single‐dose, double‐blind, 3‐arm, parallel‐group study (study 1); a single‐dose, double‐blind, 2‐way...

Descripción completa

Detalles Bibliográficos
Autores principales:	Gattu, Sreekanth, Wang, Jessie, Bellon, Anne, Schelcher, Celine, Nakov, Roumen, Arani, Ramin
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2021
Materias:	Articles
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9290022/ https://www.ncbi.nlm.nih.gov/pubmed/34350732 http://dx.doi.org/10.1002/cpdd.1005

Ejemplares similares

A large multicentre, randomized, double‐blind, cross‐over study in healthy volunteers to compare pharmacokinetics, pharmacodynamics and safety of a pegfilgrastim biosimilar with its US‐ and EU‐reference biologics
por: Bellon, Anne, et al.
Publicado: (2020)

Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of Pelmeg(®), a pegfilgrastim biosimilar in healthy subjects
por: Roth, Karsten, et al.
Publicado: (2019)

Confirmation of Biosimilarity in a Pharmacokinetic/Pharmacodynamic Study in Healthy Volunteers for an Analytically Highly Similar Pegfilgrastim
por: Desai, Kalpna, et al.
Publicado: (2016)

Pharmacodynamics, safety, and immunogenicity of Pelmeg(®), a pegfilgrastim biosimilar in healthy subjects
por: Wessels, Hendrik, et al.
Publicado: (2019)

Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer
por: Harbeck, Nadia, et al.
Publicado: (2016)

Pegfilgrastim Biosimilars: Where Are We Now?
por: Selby, Christopher, et al.
Publicado: (2021)

Sensitivity of Pegfilgrastim Pharmacokinetic and Pharmacodynamic Parameters to Product Differences in Similarity Studies
por: Brekkan, Ari, et al.
Publicado: (2019)

PF-06881894, a Proposed Biosimilar to Pegfilgrastim, Versus US-Licensed and EU-Approved Pegfilgrastim Reference Products (Neulasta(®)): Pharmacodynamics, Pharmacokinetics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers
por: Moosavi, Shahrzad, et al.
Publicado: (2020)

A Comparison of Proposed Biosimilar LA-EP2006 and Reference Pegfilgrastim for the Prevention of Neutropenia in Patients With Early-Stage Breast Cancer Receiving Myelosuppressive Adjuvant or Neoadjuvant Chemotherapy: Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2), a Phase III, Randomized, Double-Blind Trial
por: Blackwell, Kimberly, et al.
Publicado: (2016)

Efficacy and safety of two pegfilgrastim biosimilars: Tripegfilgrastim and pegteograstim
por: Kang, Ka‐Won, et al.
Publicado: (2020)

PB2416: EFFICACY AND SAFETY OF BIOSIMILAR PEGFILGRASTIM AFTER AUTOLOGOUS STEM CELL TRANSPLANT: A COMPARATIVE STUDY WITH BIOSIMILAR FILGRASTIM, LENOGRASTIM AND ORIGINATOR PEGFILGRASTIM
por: Marchesi, Francesco, et al.
Publicado: (2023)

Biosimilar Pegfilgrastim-cbqv Demonstrated Similar Immunogenicity to Pegfilgrastim in Healthy Subjects Across Three Randomized Clinical Studies
por: Civoli, Francesca, et al.
Publicado: (2022)

Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer
por: Blackwell, K., et al.
Publicado: (2017)

The first biosimilar approved for the treatment of osteoporosis: results of a comparative pharmacokinetic/pharmacodynamic study
por: Takács, I., et al.
Publicado: (2018)

Biosimilar Pegfilgrastim: Improving Access and Optimising Practice to Supportive Care that Enables Cure
por: Cornes, Paul, et al.
Publicado: (2020)

Comparability of Biosimilar Filgrastim with Originator Filgrastim: Protein Characterization, Pharmacodynamics, and Pharmacokinetics
por: Sörgel, Fritz, et al.
Publicado: (2015)

Pharmacokinetic and Pharmacodynamic Bioequivalence of Pegfilgrastim-cbqv Delivered via a Prefilled Autoinjector and Prefilled Syringe in Healthy Male Participants
por: Tang, Hong, et al.
Publicado: (2023)

Immunogenicity and safety of a proposed pegfilgrastim biosimilar MSB11455 versus the reference pegfilgrastim Neulasta(®) in healthy subjects: A randomized, double‐blind trial
por: Wynne, Chris, et al.
Publicado: (2020)

Efficacy and safety of pegfilgrastim biosimilar MD‐110 in patients with breast cancer receiving chemotherapy: Single‐arm phase III
por: Takano, Toshimi, et al.
Publicado: (2023)

Efficacy and safety of RGB-02, a pegfilgrastim biosimilar to prevent chemotherapy-induced neutropenia: results of a randomized, double-blind phase III clinical study vs. reference pegfilgrastim in patients with breast cancer receiving chemotherapy
por: Kahan, Zsuzsanna, et al.
Publicado: (2019)

A retrospective review of the real-world experience of the Pegfilgrastim biosimilar (Lapelga®) to the reference biologic (Neulasta®)
por: Wong, Gina, et al.
Publicado: (2020)

Clinical Evaluation of Humira(®) Biosimilar ONS-3010 in Healthy Volunteers: Focus on Pharmacokinetics and Pharmacodynamics
por: Dillingh, Marlous R., et al.
Publicado: (2016)

Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia
por: Waller, Cornelius F., et al.
Publicado: (2019)

Biosimilar Versus Originator Pegfilgrastim for Preventing Chemotherapy-Induced Neutropenia: A Phase III Randomized, Multicenter, Evaluator-Blinded, Noninferiority Study
por: Kowalyszyn, Ruben D., et al.
Publicado: (2022)

Structural similarity, characterization of Poly Ethylene Glycol linkage and identification of product related variants in biosimilar pegfilgrastim
por: Shekhawat, Rakesh, et al.
Publicado: (2019)

Comparative effectiveness of pegfilgrastim biosimilars vs originator for prevention of febrile neutropenia: A retrospective cohort study
por: Wang, Ching-Yu, et al.
Publicado: (2023)

Clinical confirmation to demonstrate similarity for a biosimilar pegfilgrastim: a 3-way randomized equivalence study for a proposed biosimilar pegfilgrastim versus US-licensed and EU-approved reference products in breast cancer patients receiving myelosuppressive chemotherapy
por: Desai, Kalpna, et al.
Publicado: (2018)

Comparison of biosimilar filgrastim with a reference product: pharmacokinetics, pharmacodynamics, and safety profiles in healthy volunteers
por: Choi, Chungam, et al.
Publicado: (2018)

Similar pharmacokinetics and pharmacodynamics of a new biosimilar and reference insulin aspart in healthy Chinese males
por: Liu, Hui, et al.
Publicado: (2021)

Effectiveness of biosimilar pegfilgrastim in patients with multiple myeloma after high-dose melphalan and autologous stem cell transplantation
por: Martino, Massimo, et al.
Publicado: (2023)

Analytical sameness methodology for the evaluation of structural, physicochemical, and biological characteristics of Armlupeg: A pegfilgrastim biosimilar case study
por: Deshmukh, Arati, et al.
Publicado: (2023)

Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of CMAB807, a New Denosumab Biosimilar, in Healthy Chinese Subjects
por: Chen, Hanjing, et al.
Publicado: (2022)

Pegfilgrastim Biosimilars in US Supportive Oncology: A Narrative Review of Administration Options and Economic Considerations to Maximize Patient Benefit
por: Humphreys, Sophia Z., et al.
Publicado: (2022)

Correction to: Effectiveness of biosimilar pegfilgrastim in patients with multiple myeloma after high‑dose melphalan and autologous stem cell transplantation
por: Martino, Massimo, et al.
Publicado: (2023)

Comparison of the pharmacodynamic profiles of a biosimilar filgrastim and Amgen filgrastim: results from a randomized, phase I trial
por: Waller, Cornelius F., et al.
Publicado: (2010)

Author Correction: Similar pharmacokinetics and pharmacodynamics of a new biosimilar and reference insulin aspart in healthy Chinese males
por: Liu, Hui, et al.
Publicado: (2021)

Clinical Pharmacology of Insulin Aspart Biosimilar GP40071: Pharmacokinetic/Pharmacodynamic Comparability in Hyperinsulinemic Euglycemic Clamp Procedure
por: Drai, Roman V., et al.
Publicado: (2022)

PB2051: POPULATION PHARMACOKINETIC/PHARMACODYNAMIC/EFFICACY MODELING OF SB12 (PROPOSED ECULIZUMAB BIOSIMILAR) AND REFERENCE ECULIZUMAB
por: Lee, Hyuna, et al.
Publicado: (2023)

Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and Approval
por: Strauss, David G., et al.
Publicado: (2022)

Tolerability, pharmacokinetics, and pharmacodynamics of mirogabalin in healthy subjects: Results from phase 1 studies
por: Brown, Karen, et al.
Publicado: (2018)

Cannot write session to /tmp/vufind_sessions/sess_uiql01k1m8hrsh66gfmsmb1dt4