Results 31 to 40 of about 40,241 (253)

Proceedings of the biosimilars workshop at the International Symposium on Oncology Pharmacy Practice 2019. [PDF]

, 2020
The International Society of Oncology Pharmacy Practitioners organized a workshop to create learning opportunities on biosimilars in pharmacy practice on 10 October 2019.
Chan, Alexandre, Ke, Yu, Tan, Chia Jie
core  

Physicians’ perceptions of the uptake of biosimilars: a systematic review

BMJ Open, 2020
Objectives To examine physicians’ perceptions of the uptake of biosimilars. Design Systematic review. Data sources MedLine Ovid and Scopus databases at the end of 2018.
K. Sarnola, Merja Merikoski, J. Jyrkkä, K. Hämeen-Anttila   +3 more
semanticscholar   +1 more source

Biosimilars: Harmonizing the Approval Guidelines

Biologics, 2022
Biosimilar approval guidelines need rationalization and harmonization to remove the inconsistencies and misconceptions to enable faster, safer, and more cost-effective biosimilars.
Sarfaraz K Niazi
semanticscholar   +1 more source

Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines [PDF]

, 2018
Objective: The aim was to critically evaluate well-established regulatory agencies mAb biosimilar guidelines for development and marketing authorization about quality, efficacy and safety and compare to BRICS-TM regulations to identify challenges ...
Anvisa, Castaneda-Hernandez, CBER, CBER, CBER, CBER, CBER, CBER, CBER, CDSCO, CFDA, Christl, Cofepris, Gautam, Lozda, MCC, Minghetti, Olech, Priori, Rushvi, Schiestl   +20 more
core   +5 more sources

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

Drugs, 2020
Biologics have transformed the treatment of immune-mediated inflammatory diseases such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD).
HoUng Kim, R. Alten, L. Avedano, A. Dignass, F. Gomollón, K. Greveson, J. Halfvarson, P. Irving, J. Jahnsen, P. Lakatos, JongHyuk Lee, S. Makri, B. Parker, L. Peyrin-Biroulet, S. Schreiber, S. Simoens, R. Westhovens, S. Danese, J. Jeong   +18 more
semanticscholar   +1 more source

Biosimilars in Oncology: Latest Trends and Regulatory Status

Pharmaceutics, 2022
Biologic-based medicines are used to treat a variety of diseases and account for around one-quarter of the worldwide pharmaceutical market. The use of biologic medications among cancer patients has resulted in substantial advancements in cancer treatment
D. Joshi, R. Khursheed, Saurabh Gupta, Diksha Wadhwa, T. G. Singh, Sumit Sharma, Sejal Porwal, Swati Gauniyal, Sukriti Vishwas, Sanjay Goyal, G. Gupta, R. Eri, Kylie A. Williams, K. Dua, S. Singh   +14 more
semanticscholar   +1 more source

Management of cancer-associated anemia with erythropoiesis-stimulating agents: ASCO/ASH clinical practice guideline update. [PDF]

, 2019
PURPOSE: To update the American Society of Clinical Oncology (ASCO)/American Society of Hematology (ASH) recommendations for use of erythropoiesis-stimulating agents (ESAs) in patients with cancer.
Bohlius, Julia, Bohlke, Kari, Castelli, Roberto, Djulbegovic, Benjamin, Lazo-Langner, Alejandro, Lustberg, Maryam B, Martino, Massimo, Mountzios, Giannis, Peswani, Namrata, Porter, Laura, Tanaka, Tiffany N., Trifirò, Gianluca, Yang, Hushan   +12 more
core   +3 more sources

Efficacy and Safety of Adalimumab Biosimilars: Current Critical Clinical Data in Rheumatoid Arthritis

Frontiers in Immunology, 2021
Adalimumab, as a TNF inhibitor biologic for the treatment of rheumatoid arthritis, is one of the top-selling drugs worldwide. As its various patents have gradually expired, experiments on its biosimilars are constantly being implemented.
Xiaoqin Lu, Rui Hu, Lin Peng, Mengsi Liu, Zhen Sun   +4 more
semanticscholar   +1 more source

Knowledge, Attitudes and Practice of Healthcare Providers, Healthcare Regulatory Practitioners and Patients Toward Biosimilars in China: Insights From a Nationwide Survey

Frontiers in Pharmacology, 2022
Objective: With increasing numbers of biosimilars entering the market or in the approval pipeline in China, understanding the current awareness and attitudes of biosimilars still remains the first step to promote uptake.
Yang Hu, Zaiwei Song, D. Jiang, L. Zhuo, Yinchu Cheng, Rongsheng Zhao   +5 more
semanticscholar   +1 more source

Biosimilarity assessment of biosimilar therapeutic monoclonal antibodies

Drug Metabolism and Pharmacokinetics, 2019
The concept of biosimilar was established in the early 2000s in EU. Currently, the regulatory framework for biosimilar has also been established in the US, Japan, and other countries. As of 2018, biosimilars for infliximab, adalimumab, rituximab, trastuzumab, and bevacizumab have been approved.
Akiko, Ishii-Watabe, Takashi, Kuwabara
openaire   +2 more sources