Biosimilars
Recommendations for the Development and Validation of Neutralizing Antibody Assays in Support of Biosimilar Assessment
Abstract The American Association of Pharmaceutical Scientists (AAPS) biosimilar focus group on nonclinical and clinical assays has developed this manuscript to guide the industry on…
Webinar on Demand: Recent Aspects and Challenges in the Assessment of Immunogenicity
The assessment of immunogenicity of biological protein drugs is a key component in drug development. A basic knowledge in immunology is a prerequisite for understanding…
Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments
Published by The AAPS Journal Abstract For biosimilar drug development, it is critical to demonstrate similar physiochemical characteristics, efficacy, and safety of the biosimilar product…
Measures of biosimilarity in monoclonal antibodies in oncology: the case of bevacizumab
Ebbers HC1, van Meer PJ, Moors EH, Mantel-Teeuwisse AK, Leufkens HG, Schellekens H. Measures of biosimilarity in monoclonal antibodies in oncology: the case of bevacizumab.…
Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development
Abstract Biopharmaceutical products (biologics) are active drug substances produced by living cells or derived from a living organism (bacteria, yeast, animal or human cell lines).…
Biosimilars: what clinicians should know
Weise M et al. Blood. 2012;120:5111-7. Abstract Biosimilar medicinal products (biosimilars) have become a reality in the European Union and will soon be available in the…
Setting the stage for biosimilar monoclonal antibodies
Schneider CK et al. Setting the stage for biosimilar monoclonal antibodies. Nature Biotech. 2012;30:1179-85. Abstract With the first marketing authorization application for a biosimilar monoclonal…