Cargando…

Creating China’s Biosimilar Drugs Regulatory System: A Calculated Approach

Detalles Bibliográficos
Autores principales:	Yang, Jianhong, Zhao, Xiaoyu, Li, Jie, Zhang, Kejian, Zhang, Zheru, Chang, Shunwen, Fu, Daotian, Lyu, Xinhuan, Zhang, Xianglin, Shao, Ying
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Frontiers Media S.A. 2022
Materias:	Pharmacology
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8848751/ https://www.ncbi.nlm.nih.gov/pubmed/35185570 http://dx.doi.org/10.3389/fphar.2022.815074

Ejemplares similares

Knowledge, Attitudes and Practice of Healthcare Providers, Healthcare Regulatory Practitioners and Patients Toward Biosimilars in China: Insights From a Nationwide Survey
por: Hu, Yang, et al.
Publicado: (2022)

Editorial: Biological drugs and biosimilars in autoimmune diseases
por: Wajda, Anna, et al.
Publicado: (2023)

Comparison of BRICS-TM Countries' Biosimilar Regulatory Frameworks With Australia, Canada and Switzerland: Benchmarking Best Practices
por: Rahalkar, Hasumati, et al.
Publicado: (2021)

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)

Factors associated with the uptake of biosimilars for breast cancer treatment from the perspectives of physicians and patients-Evidence from China
por: Wu, Qiyou, et al.
Publicado: (2023)

Factors influencing bioequivalence evaluation of insulin biosimilars based on a structural equation model
por: Shao, Huarui, et al.
Publicado: (2023)

The Role of Biosimilars in Uveitis: Long-Term Real-World Outcomes of the Switch From Original to Biosimilar TNF-Alpha Inhibitors
por: Fabiani, Claudia, et al.
Publicado: (2019)

The Clinical Implications of Nocebo Effects for Biosimilar Therapy
por: Colloca, Luana, et al.
Publicado: (2019)

Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines
por: Rahalkar, Hasumati, et al.
Publicado: (2018)

Diosgenin From Dioscorea Nipponica Rhizoma Against Graves’ Disease—On Network Pharmacology and Experimental Evaluation
por: Xin, Jingxin, et al.
Publicado: (2022)

Nocebo in Biosimilars and Generics in Neurology: A Systematic Review
por: Spanou, Ioanna, et al.
Publicado: (2019)

Pricing and Reimbursement of Biosimilars in Central and Eastern European Countries
por: Kawalec, Paweł, et al.
Publicado: (2017)

Switching Among Biosimilars: A Review of Clinical Evidence
por: Allocati, Eleonora, et al.
Publicado: (2022)

Biosimilar Use and Switching in Belgium: Avenues for Integrated Policymaking
por: Barbier, Liese, et al.
Publicado: (2022)

An international comparative analysis and roadmap to sustainable biosimilar markets
por: Alnaqbi, Khalid A., et al.
Publicado: (2023)

Regulatory Considerations for Biosimilars
por: Nellore, Ranjani
Publicado: (2010)

A Biosimilarity Study Between QX001S and Ustekinumab in Healthy Chinese Male Subjects
por: Gao, Lei, et al.
Publicado: (2021)

Pharmacoeconomic Evaluation of Cancer Biosimilars Worldwide: A Systematic Review
por: Huang, Hui-Yao, et al.
Publicado: (2020)

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

Perceptions About Biosimilar Medicines Among Belgian Patients in the Ambulatory Care
por: Vandenplas, Yannick, et al.
Publicado: (2022)

“Biosimilar, so it looks alike, but what does it mean?” A qualitative study of Danish patients' perceptions of biosimilars
por: Varma, Meera, et al.
Publicado: (2022)

Regulatory considerations in oncologic biosimilar drug development
por: Macdonald, Judith C, et al.
Publicado: (2015)

Efficacy and safety of adalimumab biosimilar (HS016) in inflammatory bowel disease from the real-world study
por: Wang, Fang, et al.
Publicado: (2023)

Efficacy, safety and immunogenicity of etanercept biosimilars versus reference biologics in patients with rheumatoid arthritis: A meta-analysis
por: Hu, Rui, et al.
Publicado: (2023)

Off-Patent Biological and Biosimilar Medicines in Belgium: A Market Landscape Analysis
por: Vandenplas, Yannick, et al.
Publicado: (2021)

Policies to Encourage the Use of Biosimilars in European Countries and Their Potential Impact on Pharmaceutical Expenditure
por: Vogler, Sabine, et al.
Publicado: (2021)

A Randomized Phase 1 Pharmacokinetic Study Comparing the Potential Biosimilar LRG201902 With Liraglutide (Victoza(®)) in Healthy Male Subjects
por: Mai, Gang, et al.
Publicado: (2021)

Biological Therapies in Immune-Mediated Inflammatory Diseases: Can Biosimilars Reduce Access Inequities?
por: Baumgart, Daniel C., et al.
Publicado: (2019)

Intensive Safety Monitoring of Rituximab (Biosimilar Novex(®) and the Innovator) in Pediatric Patients With Complex Diseases
por: Riva, Natalia, et al.
Publicado: (2022)

Changes in Efficacy Indicators for Adalimumab Biosimilar Candidate (HS016) for the Treatment of Active Ankylosing Spondylitis at Various Time Points
por: Su, Jinmei, et al.
Publicado: (2020)

A randomized, double-blind, parallel control study to evaluate the biosimilarity of QL1209 with Perjeta(®) in healthy male subjects
por: Sun, Yuanyuan, et al.
Publicado: (2022)

A Randomized, Double-Blind, Single-Dose Study Comparing the Biosimilarity of HOT-1010 With Bevacizumab (Avastin®) in Chinese Healthy Male Subjects
por: Huang, Kai, et al.
Publicado: (2021)

Evaluating the benefits of TNF-alfa inhibitor biosimilar competition on off-patent and on-patent drug markets: A Southern European analysis
por: Barcina Lacosta, Teresa, et al.
Publicado: (2022)

A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of QL1206 to Denosumab Among Chinese Healthy Subjects
por: Zhang, Hong, et al.
Publicado: (2020)

Smilax china L. Polysaccharide Alleviates Oxidative Stress and Protects From Acetaminophen-Induced Hepatotoxicity via Activating the Nrf2-ARE Pathway
por: Wang, Kaiping, et al.
Publicado: (2022)

Biosimilar Oncology Drugs in Europe: Regulatory and Pharmacovigilance Considerations
por: Francescon, Sara, et al.
Publicado: (2016)

LZM008, a proposed tocilizumab biosimilar: Pharmacokinetics, safety, and immunogenicity profiles compared with ACTEMRA(®) in Chinese healthy male subjects
por: Cao, Guoying, et al.
Publicado: (2023)

Efficacy and Safety of Bevacizumab Biosimilars Compared With Reference Biologics in Advanced Non-small Cell Lung Cancer or Metastatic Colorectal Cancer Patients: A Network Meta-Analysis
por: Xu, Xinyi, et al.
Publicado: (2022)

Comparison of clot lysis activity and biochemical properties of originator tenecteplase (Metalyse(®)) with those of an alleged biosimilar
por: Kliche, Werner, et al.
Publicado: (2014)

Biosimilars in Pediatric Inflammatory Bowel Diseases: A Systematic Review and Real Life-Based Evidence
por: Dipasquale, Valeria, et al.
Publicado: (2022)

Cannot write session to /tmp/vufind_sessions/sess_es2q30hrmjkh7ivjcmermacrni