Findings on Biotechnology Detailed by Investigators at Biogen (A Retrospective Analysis of the Potential Impact of Differences In Aggregates On Clinical Immunogenicity of Biosimilars and Their Reference Products).

A study conducted by Biogen investigated the potential impact of differences in aggregates on the clinical immunogenicity of biosimilars and their reference products. The study found that there were limited differences in the content of high molecular weight species (HMWs) between marketed biosimilars and reference monoclonal antibodies (mAbs). These differences were not associated with differences in reported immunogenicity, as measured by the incidence of antidrug-antibodies (ADAs) and neutralizing ADAs in comparative clinical studies. The study suggests that HMWs may not have a significant impact on the immunogenicity of biosimilars. [Extracted from the article]