Cargando…

Biosimilar Pegfilgrastim-cbqv Demonstrated Similar Immunogenicity to Pegfilgrastim in Healthy Subjects Across Three Randomized Clinical Studies

INTRODUCTION: Biologic therapeutics can trigger immune responses in patients. As part of the totality of evidence that is required for regulatory approval of biosimilars, immunogenicity similarity must be assessed in the clinical programs. Pegfilgrastim-cbqv (UDENYCA(®)) is a pegfilgrastim biosimila...

Descripción completa

Detalles Bibliográficos
Autores principales:	Civoli, Francesca, Finck, Barbara, Tang, Helen, Hodge, Jennifer, O’Kelly, Hillary, Vexler, Vladimir
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Springer Healthcare 2022
Materias:	Original Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8918144/ https://www.ncbi.nlm.nih.gov/pubmed/35034311 http://dx.doi.org/10.1007/s12325-021-02024-x

Ejemplares similares

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)

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

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

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

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 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)

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)

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

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

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

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)

The Safety Profile of Filgrastim and Pegfilgrastim
por: Neumann, Theresa A., et al.
Publicado: (2011)

Meta‐analysis of Pharmacokinetic/Pharmacodynamic Results of 3 Phase 1 Studies with Biosimilar Pegfilgrastim
por: Gattu, Sreekanth, et al.
Publicado: (2021)

Design Rationale and Development Approach for Pegfilgrastim as a Long-Acting Granulocyte Colony-Stimulating Factor
por: Arvedson, Tara, et al.
Publicado: (2015)

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

Pegfilgrastim in Supportive Care of Hodgkin Lymphoma
por: Cerchione, Claudio, et al.
Publicado: (2022)

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)

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

Relapsing Acute Kidney Injury Associated with Pegfilgrastim
por: Arora, Swati, et al.
Publicado: (2012)

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

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)

Pegfilgrastim for primary prophylaxis of febrile neutropenia in multiple myeloma
por: Cerchione, Claudio, et al.
Publicado: (2021)

Cyclophosphamide/docetaxel/pegfilgrastim: Various toxicities: case report
Publicado: (2021)

Evaluation of a novel medical device for pegfilgrastim administration
por: Aruga, Tomoyuki, et al.
Publicado: (2022)

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)

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)

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)

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)

Safety of Pegfilgrastim (Neulasta) in Patients with Sickle Cell Trait/Anemia
por: Kasi, Pashtoon Murtaza, et al.
Publicado: (2013)

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)

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)

Pseudogout Attack after Pegfilgrastim Administration in Anaplastic Large Cell Lymphoma
por: Hatayama, Mayumi, et al.
Publicado: (2018)

Neutrophilic eccrine hidradenitis secondary to pegfilgrastim in a patient with synovial sarcoma
por: Puar, Neha, et al.
Publicado: (2019)

Recurrent Granulocyte Colony-Stimulating Factor-Induced Aortitis After Pegfilgrastim Administration
por: Kawahara, Hiroshi, et al.
Publicado: (2020)

Drug-induced aortitis of the subclavian artery caused by pegfilgrastim: a case report
por: Jimbo, Hikari, et al.
Publicado: (2021)

A Case of Concurrent Leukocytosis and Systemic Capillary Leak Syndrome Due to Pegfilgrastim
por: Gotera, Nico, et al.
Publicado: (2022)

Effectiveness of cytopenia prophylaxis for different filgrastim and pegfilgrastim schedules in a chemotherapy mouse model
por: Scholz, Markus, et al.
Publicado: (2009)

Cannot write session to /tmp/vufind_sessions/sess_42d5e1jac4v9aabh0oqd4vkomd