Juyong Hong, Yuhwa Lee, Changsoo Lee, Suhyeon Eo, Soyeon Kim, Nayoung Lee, Jongmin Park, Seungkyu Park, Donghyuck Seo, Min Jeong, Youngji Lee, Soojeong Yeon, George Bou-Assaf, Zoran Sosic, Wei Zhang, Orlando Jaquez
A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product. Biosimilarity to the reference product (RP) in terms of quality characteristics, such as physicochemical and biological properties, safety, and efficacy, based on a comprehensive comparability exercise needs to be established. SB2 (Flixabi® and Renflexis®) is a biosimilar to Remicade® (infliximab). The development of SB2 was performed in accordance with relevant guidelines of the International Conference on Harmonisation, the European Medicines Agency, and the United States Food and Drug Administration...
February 2017: MAbs