Biosimilars

Track evolving approaches in biosimilar development and analysis.

Visual representation of LC-MS workflows for biopharma analysis
eBooksExplore advanced LC-MS workflows for biopharma that improve efficiency and regulatory confidence in next-gen research.
ArticlesA deep dive into the FDA’s evolving 2025 and 2026 draft guidances, which pivot biosimilar approval away from traditional clinical efficacy trials and heavily toward high-resolution analytical comparability and targeted pharmacokinetic studies.
BlogsDifluoroacetic acid (DFA) is discussed as a suitable alternative to TFA and FA in the LC-UV/MS analysis of proteins.
BlogsThree step-by-step protocols to monitor critical quality attributes (CQAs) of monoclonal antibodies were developed using adalimumab as an example.