Since the approval of the first monoclonal antibody (mAb) in 1986, a huge effort has been
made to guarantee safety and efficacy of therapeutic mAbs. As of July 2021, 118 mAbs are …

Highlights•Licensing of biosimilars promotes wider patient access to essential
medicines.•Currently, regulators require comparative efficacy trials for complex …

The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held on
27 September to 1 October 2021. Even with a last-minute move from in-person to virtual, an …

Since the first approval of a biosimilar medicinal product in 2006, scientific understanding of
the features and development of biosimilar medicines has accumulated. This review …

Antibody Fc effector function is one of the main mechanisms of action (MoA) for therapeutic
monoclonal antibodies. Measurement of antibody‐dependent cellular cytotoxicity (ADCC) is …

Medical anthropology teaches us of historical disparity in the accessibility of medicines in
the developing world due to their lack of availability and affordability, more particularly of …

Immunoglobulin G (IgG) antibodies possess a conserved N-glycosylation site in the Fc
domain. In FcγRIIIa affinity column chromatography, unglycosylated, hemiglycosylated, and …

Both basic and translational research are continuously evolving, but the principles that
underpin research integrity remain constant. These include rational, hypothesis-driven, and …

To the Editor—The debate concerning biosimilar monoclonal antibodies (mAbs) has
matured over the past 10 years. During the early 2000s, it centered on (i) whether …

Due to the increase in the number of infliximab products, the need for global harmonization
of the bioactivity of this monoclonal antibody was recognized by the World Health …