Results 211 to 220 of about 790,096 (261)

Consideration of the biosimilar drug lag and loss among Japan, the USA, and the EU

Naunyn-Schmiedeberg's Archives of Pharmacology
Ryosuke Kuribayashi
exaly   +2 more sources

Assessment of structural and functional similarity of biosimilar products: Bevacizumab as a case study.

Journal of chromatography. B, Analytical technologies in the biomedical and life sciences, 2023
The antiangiogenic drug bevacizumab is a blockbuster therapeutic pharmaceutical product that is used to treat many different types of cancer including kidney, colon, rectum, lung, and breast cancer.
Sanghati Bhattacharya, Anurag S. Rathore
semanticscholar   +1 more source

Biosimilarity. Do not confuse biosimilar and biocopy. Example of tenecteplase.

Annales Pharmaceutiques Françaises, 2023
Non-innovator biological products (NIBPs) or 'biocopies' are available in several countries at lower prices than biosimilars. These drugs, sometimes so-called 'biosimilars', may not meet all of the quality criteria expected of clinically equivalent ...
A. Astier, R. Abouqal, L. Abid, Y. Aoudia, S. Ahid   +4 more
semanticscholar   +1 more source

Analytical and functional similarity of biosimilar Elizaria® with eculizumab reference product.

Journal of Pharmaceutical and Biomedical Analysis, 2022
A recombinant humanized monoclonal antibody (mAb) Eculizumab, C5-complement cascade inhibitor, is an important treatment of complement-based diseases recommended by international guidelines. Elizaria® Drug Product (DP), developed by IBC Generium, Russia,
V. Gusarova, M. Degterev, I. Lyagoskin, V. Simonov, M. Smolov, Sergey Taran, R. Shukurov   +6 more
semanticscholar   +1 more source

Chromatographic and electrophoretic assessment of Filgrastim biosimilars in pharmaceutical formulations

Journal of Pharmaceutical and Biomedical Analysis, 2014
An orthogonal testing protocol was developed and validated to assess the quality of Filgrastim biosimilars. Results were compared to those obtained from the innovator product. Initial screening was carried out using reducing and non-reducing gel electrophoresis.
Eman L, Shaltout, Medhat A, Al-Ghobashy, Faten A, Fathalla, Maissa Y, Salem   +3 more
openaire   +2 more sources

Generic Medicines and Biosimilars: Impact on Global Pharmaceutical Policy

2020
Patient access to safe and cost-effective treatment is an important goal for the healthcare system. The development of biosimilar compounds and generic medicines is interesting to the industry and society to reduce healthcare costs, fulfill the needs of healthcare stakeholders and potentially increase accessibility to patients.
Ibrahim, Mohamed Izham Mohamed, Awaisu, Ahmed.   +1 more
openaire   +3 more sources

Quality by Design applications in biosimilar pharmaceutical products

Accreditation and Quality Assurance, 2008
A process is well understood when all critical sources of variability are identified and explained, variability is managed by the process design and monitoring, and product quality attributes are accurately and reliably predicted over the design space.
Ron S. Kenett, Dan A. Kenett
openaire   +1 more source

FYB-201 Biosimilar ranibizumab (Ongavia/Ranivisio/Cimerli) Efficacy and Safety in Clinical Settings – FORCE study

Eye
Purpose: To understand the early experience of ranibizumab biosimilar (FYB 201) that has been approved in the United Kingdom (Ongavia, Teva Pharmaceuticals, Tel Aviv Israel), United States (Cimerli, Sandoz Inc, Princeton, NJ, USA) and Europe (Ranivisio ...
Ashish Sharma, Luke Nicholson, C. Vazquez-Alfageme, Vasuki Sivagnanavel, Riccardo Fausto, M. Soare, Marta Bautista Salamanca, Lorenzo Fabozzi, Chrysanthi Tsika, Olga Cejudo Corbalan, Alejandro Gomez Verdejo, Taku Wakabayashi, Se Joon Woo, Anton M. Kolomeyer, Hana A. Mansour, Bita Momenaei, C. Regillo, B. Kuppermann, Anat Loewenstein, Francesco Bandello, Giuseppe Querques, Tomoko Ueda-Consolvo, Masaaki Ishida, Tomoko Nakamura, Shuichiro Yanagisawa, Atsushi Hayashi, Kotaro Tsuboi, Nilesh Kumar, N. Parachuri, Jay Sheth, Seemantini Ayachit, Chitaranjan Mishra, Debdulal Chakraborty, A. Banker, K. Rezaei, A. Khanani, Peter K. Kaiser, F. Holz, S. Sivaprasad, Ş. Özdek, Kodjikian Laurent, Alper Bilgic, Paolo Lanzetta, Valentina Sarao, Caroline R Baumal, Nancy Holekemp, Taiji Sakamoto, A. Tufail, Nicolas A. Yannuzzi, Jayanth Sridhar, Giulia Corradetti, A. Hilely, D. Boyer, Aleksandra Rachitskaya, T. Peto, Maximilian W. M. Wintergerst, Barbara Parolini, P. Mruthyunjaya, Q. D. Nguyen, D. V., P. Keane, Tarek Hassan, David A. Eichenbaum, Dilraj S. Grewal, Francesc March, Martin S. Spitzer, K. Falavarjani, Martin Zinkernagel, C. Lee, Judy E. Kim   +69 more
semanticscholar   +2 more sources

Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions

The Lancet Oncology, 2020
The EU, the USA, and Japan account for the majority of biological pharmacotherapy use worldwide. Biosimilar regulatory approval pathways were authorised in the EU (2006), in Japan (2009), and in the USA (2015), to facilitate approval of biological drugs ...
C. L. Bennett, M. Schoen, Shamia Hoque, Bartlett J. Witherspoon, D. Aboulafia, Catherine S. Hwang, Paul S. Ray, P. Yarnold, Brian K. Chen, Benjamin L. Schooley, Matthew A. Taylor, M. D. Wyatt, W. Hrushesky, Y. T. Yang   +13 more
semanticscholar   +1 more source

Pharmaceutical advice by phone enhances use of infliximab biosimilars

2018
25.
van Eijk, SC, Arndt, LK, Neitemeier, S
openaire   +2 more sources