Biosimilar antibody drug conjugates: considerations of higher order structure and aggregation

Abstract: Undoubtedly the complexity of antibody drug conjugate (ADC) molecules where three components (monoclonal antibody, cytotoxic drug and appropriate linker) are involved poses a challenge for biosimilar development. As with all biomolecule development, both novel and biosimilar, it is important to choose orthogonal analytical techniques to interrogate Quality Attributes, particularly for higher order structure (HOS) […]


Critical immunogenicity differences will be obscured by a common INN for biosimilars

Abstract: Information about variable immunogenicity arising from formulation differences between competing biosimilars is critical for informed judgments by prescribing physicians. Use of a common INN for biosimilars will obfuscate such differences to the detriment of patients. Submitted: 31 October 2013; Revised: 12 November 2013; Accepted: 13 November 2013; Published online first: 26 November 2013 Immunogenicity […]