FDA-approved anti-TNFα biopharmaceuticals are successful in treating a range of
autoimmune diseases. However, not all anti-TNFα products are identical in their patient …

In this study, we demonstrate the utility of ultra-performance liquid chromatography coupled
to mass spectrometry (MS) and ion-mobility spectrometry (IMS) to characterize and compare …

Characterization of therapeutic monoclonal antibodies (mAbs) represents a major challenge
for analytical sciences due to their heterogeneity associated with post-translational …

In April 2016, the Food and Drug Administration approved the first biosimilar monoclonal
antibody (mAb), Inflectra/Remsima (Celltrion), based off the original product Remicade …

ABSTRACT A biosimilar is a biological medicinal product that contains a version of the
active substance of an already authorized original biological medicinal product. Biosimilarity …

Healthcare systems worldwide are struggling to find ways to fund the cost of innovative
treatments such as gene therapies, regenerative medicine, and monoclonal antibodies …

As biosimilars enter the market, comparisons of product quality are needed. Manufacturing
differences may lead to differences in critical quality attributes, which affect efficacy …

Biosimilars are poised to reduce prices and increase patient access to expensive, but highly
effective biologic products. However, questions still remain about the degree of similarity …

Biosimilars are biological products that are highly similar to existing products approved by
health authorities. Demonstration of similarity starts with the comprehensive analysis of the …

A biosimilar is a biological medicinal product that is highly similar to an authorized biological
product in terms of quality, biological activity, safety and efficacy. SB5 was developed by …