NMR based quality evaluation of mAb therapeutics: A proof of concept higher order structure biosimilarity assessment of trastuzumab biosimilars.
Sign Up to like & getrecommendations! Published in 2022 at "Journal of pharmaceutical and biomedical analysis"
DOI: 10.1016/j.jpba.2022.114710
Abstract: Higher-order structural (HOS) biosimilarity assessment is a regulatory requirement for intended biosimilars, and manufacturers are required to demonstrate the biosimilarity of their product in comparison to the reference product concerning both safety and efficacy. NMR… read more here.
Keywords: biosimilarity assessment; biosimilarity; order structure; assessment ... See more keywords
Guest editor’s note: Special issue on biosimilarity assessment
Sign Up to like & getrecommendations! Published in 2017 at "Journal of Biopharmaceutical Statistics"
DOI: 10.1080/10543406.2017.1272396
Abstract: Research on assessing similarity between two biologics has received much attention in recent years, as the biologics patent cliff began in the US drug market in 2012 (Calo-Fernández andMartínez-Hurtado, 2012). The Biologics Price Completion and… read more here.
Keywords: equivalence; product; drug; sample size ... See more keywords
Use of multibiomarker disease activity scores in biosimilarity studies for the treatment of patients with rheumatoid arthritis
Sign Up to like & getrecommendations! Published in 2022 at "RMD Open"
DOI: 10.1136/rmdopen-2022-002423
Abstract: Objectives This exploratory analysis investigated the potential use of the multibiomarker disease activity (MBDA) score to support biosimilarity assessments using data from two randomised controlled trials (RCTs) of biosimilar infliximab (IFX-qbtx) and biosimilar adalimumab (ADL-afzb)… read more here.
Keywords: disease; ifx; disease activity; adl ... See more keywords