a Department of Chemical Engineering , Indian Institute of Technology , Hauz Khas, New Delhi , India.
MAbs. 2018 Jan;10(1):143-158. doi: 10.1080/19420862.2017.1402996. Epub 2017 Dec 7.
Biosimilars are products that are similar in terms of quality, safety, and efficacy to an already licensed reference/ innovator product and are expected to offer improved affordability. The most significant source of reduction in the cost of development of a biosimilar is the reduced clinical examination that it is expected to undergo as compared to the innovator product. However, this clinical relief is predicated on the assumption that there is analytical similarity between the biosimilar and the innovator product. As a result, establishing analytical similarity is arguably the most important step towards successful development of a biosimilar. Here, we present results from an analytical similarity exercise that was performed with five biosimilars of rituximab (Ristova®, Roche), a chimeric mouse/ human monoclonal antibody biotherapeutic, that are available on the Indian market. The results show that, while the biosimilars exhibited similarity with respect to protein structure and function, there were significant differences with respect to size heterogeneity, charge heterogeneity and glycosylation pattern.
生物类似药是指在质量、安全性和疗效方面与已获得许可的参比/创新产品相似的产品,预计能提供更高的可负担性。与创新产品相比,生物类似药的开发成本降低的最大来源是预期进行的临床检查减少。然而,这种临床缓解是基于生物类似药和创新产品之间存在分析相似性的假设。因此,建立分析相似性可以说是成功开发生物类似药的最重要步骤。在这里,我们展示了在印度市场上可用的五种利妥昔单抗(Ristova®,罗氏)生物类似药的分析相似性研究的结果。结果表明,虽然这些生物类似药在蛋白质结构和功能方面表现出相似性,但在大小异质性、电荷异质性和糖基化模式方面存在显著差异。