Cargando…

Clinical trials for authorized biosimilars in the European Union: a systematic review

AIM: In 2006, Omnitrope (by Sandoz) was the first approved biosimilar in Europe. To date, 21 biosimilars for seven different biologics are on the market. The present study compared the clinical trials undertaken to obtain market authorization. METHODS: We summarized the findings of a comprehensive r...

Descripción completa

Detalles Bibliográficos
Autores principales:	Mielke, Johanna, Jilma, Bernd, Koenig, Franz, Jones, Byron
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2016
Materias:	Systematic Reviews
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5099555/ https://www.ncbi.nlm.nih.gov/pubmed/27580073 http://dx.doi.org/10.1111/bcp.13076

Ejemplares similares

An update on the clinical evidence that supports biosimilar approvals in Europe
por: Mielke, Johanna, et al.
Publicado: (2018)

Refinement in the European Union: A Systematic Review
por: Díez-Solinska, Alina, et al.
Publicado: (2022)

Overcoming Barriers to the Market Access of Biosimilars in the European Union: The Case of Biosimilar Monoclonal Antibodies
por: Moorkens, Evelien, et al.
Publicado: (2016)

Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies
por: Cohen, Hillel P., et al.
Publicado: (2022)

Switching Reference Medicines to Biosimilars: A Systematic Literature Review of Clinical Outcomes
por: Cohen, Hillel P., et al.
Publicado: (2018)

Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review
por: McKinnon, Ross A., et al.
Publicado: (2018)

Biosimilars for the Treatment of Cancer: A Systematic Review of Published Evidence
por: Jacobs, Ira, et al.
Publicado: (2017)

Biosimilars entering the clinic without animal studies: A paradigm shift in the European Union
por: van Aerts, Leon AGJM, et al.
Publicado: (2014)

Patients Retransitioning from Biosimilar TNFα Inhibitor to the Corresponding Originator After Initial Transitioning to the Biosimilar: A Systematic Review
por: Meijboom, Rosanne W., et al.
Publicado: (2021)

Systematic Review on the Use of Biosimilars of Trastuzumab in HER2+ Breast Cancer
por: Triantafyllidi, Eleni, et al.
Publicado: (2022)

Biosimilars for the Treatment of Chronic Inflammatory Diseases: A Systematic Review of Published Evidence
por: Jacobs, Ira, et al.
Publicado: (2016)

Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab
por: Feagan, Brian G., et al.
Publicado: (2018)

Validity and Reliability of IPAQ-SF and GPAQ for Assessing Sedentary Behaviour in Adults in the European Union: A Systematic Review and Meta-Analysis
por: Meh, Kaja, et al.
Publicado: (2021)

Cyberbullying and Associated Factors in Member Countries of the European Union: A Systematic Review and Meta-Analysis of Studies with Representative Population Samples
por: Henares-Montiel, Jesús, et al.
Publicado: (2022)

Quantifying Collision Frequency and Intensity in Rugby Union and Rugby Sevens: A Systematic Review
por: Paul, Lara, et al.
Publicado: (2022)

Performance Analysis in Rugby Union: a Critical Systematic Review
por: Colomer, Carmen M. E., et al.
Publicado: (2020)

The Biosimilar Nocebo Effect? A Systematic Review of Double-Blinded Versus Open-Label Studies
por: Odinet, Johlee S., et al.
Publicado: (2018)

Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence
por: Jacobs, Ira, et al.
Publicado: (2016)

The Incidence of Injury in Amateur Male Rugby Union: A Systematic Review and Meta-Analysis
por: Yeomans, Caithriona, et al.
Publicado: (2018)

Systematic review of dynamization vs exchange nailing for delayed/non-union femoral fractures
por: Vaughn, Jacob E, et al.
Publicado: (2018)

Indian Biosimilars and Vaccines at Crossroads–Replicating the Success of Pharmagenerics
por: Panda, Sunita, et al.
Publicado: (2023)

Clinical practice guidelines with recommendations for peripartum depression: A European systematic review
por: Motrico, Emma, et al.
Publicado: (2022)

The Use of Global Positioning and Accelerometer Systems in Age-Grade and Senior Rugby Union: A Systematic Review
por: Bridgeman, Lee A., et al.
Publicado: (2021)

Systematic Review of Authentication and Authorization Advancements for the Internet of Things
por: Trnka, Michal, et al.
Publicado: (2022)

Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency
por: Elsäßer, Amelie, et al.
Publicado: (2014)

The Incidence, Cost, and Burden of Concussion in Women’s Rugby League and Rugby Union: A Systematic Review and Pooled Analysis
por: King, Doug A., et al.
Publicado: (2022)

European Stakeholder Learnings Regarding Biosimilars: Part II—Improving Biosimilar Use in Clinical Practice
por: Barbier, Liese, et al.
Publicado: (2020)

Single, very low rituximab doses in healthy volunteers - a pilot and a randomized trial: implications for dosing and biosimilarity testing
por: Schoergenhofer, Christian, et al.
Publicado: (2018)

COVID‐19 and the Emerging Regulatory Guidance for Ongoing Clinical Trials in the European Union
por: de Jong, Amos Jochanan, et al.
Publicado: (2021)

Biological and molecular profile of fracture non-union tissue: current insights
por: Panteli, Michalis, et al.
Publicado: (2015)

Breast cancer research and the European Union Clinical Trials Directive
por: Williams, Norman
Publicado: (2004)

Physicians’ perceptions of the uptake of biosimilars: a systematic review
por: Sarnola, Kati, et al.
Publicado: (2020)

Systematic Review of Gossypol/AT-101 in Cancer Clinical Trials
por: Renner, Olga, et al.
Publicado: (2022)

Biosimilar insulins: a European perspective
por: DeVries, J H, et al.
Publicado: (2015)

Therapeutic Efficacy and Safety of Osteoinductive Factors and Cellular Therapies for Long Bone Fractures and Non-Unions: A Meta-Analysis and Systematic Review
por: Kaspiris, Angelos, et al.
Publicado: (2022)

Neonatal sepsis: a systematic review of core outcomes from randomised clinical trials
por: Henry, Cían J., et al.
Publicado: (2022)

Authors’ Reply to Pires et al.: “Switching Reference Medicines to Biosimilars: A Systematic Literature Review of Clinical Outcomes”
por: Cohen, Hillel P., et al.
Publicado: (2018)

Failures in Clinical Trials in the European Union: Lessons from the Polish Experience
por: Waligora, Marcin
Publicado: (2012)

Impact of COVID-19 on clinical trials and clinical research: A systematic review
por: Sathian, Brijesh, et al.
Publicado: (2020)

Tuberculosis treatment outcome monitoring in European Union countries: systematic review
por: van Hest, Rob, et al.
Publicado: (2013)

Cannot write session to /tmp/vufind_sessions/sess_0j2fahnvm6nov0982980p3p20f