Formycon AG, Martinsried, Planegg, Germany.
Drugs R D. 2024 Sep;24(3):447-464. doi: 10.1007/s40268-024-00485-3. Epub 2024 Sep 4.
Biological medicinal products improve patients' lives, but access is limited, mainly due to high costs. Patents for many existing biological products are expiring, and generic versions, which are referred to as biosimilars, are produced to serve as an alternative to the reference medicinal product (RMP) cutting down the costs and expanding access. The present paper assesses the analytical similarity between Formycon's FYB206 pembrolizumab biosimilar candidate and Keytruda, an RMP that is approved to treat various types of cancer, with the intention of determining FYB206's suitability to enter clinical biosimilar trials.
Monoclonal antibodies (mAbs) are biological medicinal products that are characterized by a high overall heterogeneity. Due to the complex nature of these molecules, a comprehensive comparative analytical assessment was designed to demonstrate analytical similarity in all clinically relevant quality attributes between RMP and the corresponding biosimilar candidate. This exercise addresses physicochemical, biophysical as well as functional characteristics.
The comparative analytical evaluation results demonstrate that the proposed biosimilar is structurally and functionally highly similar to the RMP, showing only minor differences for some quality attributes that are justified to be noncritical for clinical efficacy and safety.
Based on physicochemical and biological characteristics, FYB206 is suitable to enter the clinical phase.
生物药物改善了患者的生活，但由于成本高，其可及性有限。许多现有生物产品的专利即将到期，而仿制药（即生物类似药）被生产出来作为参考药物（RMP）的替代品，以降低成本并扩大可及性。本文评估了 Formycon 的 FYB206 帕博利珠单抗生物类似药候选药物与 Keytruda（一种已被批准用于治疗多种癌症的 RMP）之间的分析相似性，旨在确定 FYB206 是否适合进入临床生物类似药试验。
单克隆抗体（mAbs）是生物药物，其总体异质性很高。由于这些分子的复杂性质，设计了全面的比较分析评估，以证明 RMP 和相应的生物类似药候选药物在所有临床相关质量属性方面具有分析相似性。这项工作涉及理化、生物物理和功能特性。
比较分析评估结果表明，拟议的生物类似药在结构和功能上与 RMP 高度相似，仅对某些质量属性存在微小差异，这些差异被证明对临床疗效和安全性没有关键性影响。
基于理化和生物学特性，FYB206 适合进入临床阶段。
