Results 171 to 180 of about 681,456 (227)

Gel Electrophoretic Methods for The Analysis of Biosimilar Pharmaceuticals Using The Example of Recombinant Erythropoietin

Bioanalysis, 2013
Due to their versatility and cost-effectiveness, gel electrophoretic methods provide an important set of tools for the analysis of therapeutic proteins. As an increasing number of biosimilar pharmaceuticals are entering the market, techniques are required that allow reliable demonstration of comparability of these products with the reference products ...
Christian Reichel, Mario Thevis
exaly   +4 more sources

Efforts of the Pharmaceuticals and Medical Devices Agency of Japanese regulatory agency in supporting biosimilar development and disseminate information

Naunyn-Schmiedeberg's Archives of Pharmacology
Information on biosimilars was rarely disseminated on the Pharmaceuticals and Medical Devices Agency (PMDA) website of the Japanese Regulatory Agency until the fiscal year (FY) 2022. Therefore, the PMDA website for biosimilars was created in FY 2023.
Ryosuke Kuribayashi, Kuribayashi Ryosuke   +1 more
exaly   +4 more sources

Addressing the health technology assessment of biosimilar pharmaceuticals

Current Medical Research and Opinion, 2010
Abstract The growing number of biosimilars presents challenges to regulatory and health technology assessment (HTA) systems. This paper illustrates these challenges by focusing on biosimilars used in the oncological setting. In particular, discordances between data required by regulatory and HTA authorities potentially deprive patients of effective ...
Alan, Stewart, Philip, Aubrey, Jonathan, Belsey   +2 more
openaire   +3 more sources

Survey on the Role of Comparative Efficacy Studies Required for Biosimilar Monoclonal Antibody Approval in Japan to Justify the Quality Attribute Differences Between Biosimilars and Their Reference Products Based on the Pharmaceuticals and Medical Devices Agency (PMDA) Assessments

Pharmaceutical Medicine
Ryosuke Kuribayashi, Kuribayashi Ryosuke   +1 more
exaly   +2 more sources

Can biosimilar products be interchangeable? Pharmaceutical perspective in the implementation of biosimilars in oncology

Journal of Oncology Pharmacy Practice, 2021
Objective To evaluate the safety in the interchangeability of biosimilar products approved for cancer treatment from a pharmaceutical perspective. Methods A literature review was carried out using the descriptors “Biosimilar ...
José Cleberson Santos Soares, Iago Dillion Lima Cavalcanti, Juliana Lúcia de Albuquerque Vasconcelos   +2 more
openaire   +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, Ivan Lyagoskin, V. Simonov, M. Smolov, Sergey Taran, Rahim 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

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