Schiestl Martin, Li Jing, Abas Arpah, Vallin Antonio, Millband Jennifer, Gao Kai, Joung Jeewon, Pluschkell Stefanie, Go Thomas, Kang Hye-Na
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria.
Shanghai CP-Guojian Pharmaceutical Co., Ltd, China.
Biologicals. 2014 Mar;42(2):128-32. doi: 10.1016/j.biologicals.2013.11.009. Epub 2013 Dec 24.
A determination of biosimilarity is based on a thorough characterization and comparison of the quality profiles of a similar biotherapeutic product and its reference biotherapeutic product. Although the general principles on the role of the quality assessment in a biosimilar evaluation are widely understood and agreed, detailed discussions have not been published yet. We try to bridge this gap by presenting a case study exercise based on fictional but realistic data to highlight key principles of an evaluation to determine the degree of similarity at the quality level. The case study comprises three examples for biosimilar monoclonal antibody candidates. The first describes a highly similar quality profile whereas the second and third show greater differences to the reference biotherapeutic product. The aim is to discuss whether the presented examples can be qualified as similar and which additional studies may be helpful in enabling a final assessment. The case study exercise was performed at the WHO implementation workshop for the WHO guidelines on quality assessment of similar biotherapeutic products held in Xiamen, China, in May 2012. The goal was to illustrate the interpretation of the comparative results at the quality level, the role of the quality assessment in the entire biosimilarity exercise and its influence on the clinical evaluation. This paper reflects the outcome of the exercise and discussion from Xiamen.
生物相似性的判定基于对相似生物治疗产品及其参照生物治疗产品质量概况的全面表征和比较。尽管质量评估在生物相似性评价中的作用的一般原则已得到广泛理解和认同，但尚未发表详细的讨论。我们通过基于虚构但现实的数据进行案例研究练习来弥合这一差距，以突出评估的关键原则，从而在质量层面确定相似程度。该案例研究包含三个生物相似性单克隆抗体候选药物的例子。第一个描述了高度相似的质量概况，而第二个和第三个则显示出与参照生物治疗产品有更大差异。目的是讨论所呈现的例子是否可被认定为相似，以及哪些额外的研究可能有助于进行最终评估。该案例研究练习是在2012年5月于中国厦门举行的世界卫生组织（WHO）关于相似生物治疗产品质量评估指南的实施研讨会上进行的。目的是说明质量层面比较结果的解读、质量评估在整个生物相似性评估中的作用及其对临床评价的影响。本文反映了厦门研讨会的练习和讨论结果。
