Green Philip, Schneider Andreas, Lange Jakob
Chesapeake Pharma LLC, Weehawken, NJ, USA.
Delivery Systems, Ypsomed AG, Burgdorf, Switzerland.
MAbs. 2024 Jan-Dec;16(1):2402713. doi: 10.1080/19420862.2024.2402713. Epub 2024 Sep 15.
Subcutaneous (SC) administration is transforming the delivery of biopharmaceuticals, facilitating care in a variety of healthcare settings, including home self-treatment. Large-volume single SC doses have gained attention for their potential to expand therapeutic applications and improve long-term, patient-centric dosing regimens, often at a reduced SC injection frequency. However, a systematic understanding of dose volumes and frequencies for large-volume (>2.0 mL) SC biopharmaceuticals (LVSCs) is lacking. Accordingly, this study systematically reviewed clinical-stage and approved intravenous (IV) and SC biopharmaceuticals, identifying 182 LVSCs - predominantly monoclonal or bispecific antibodies - which correspond to approximately 15% of all IV and SC biopharmaceuticals. These LVSCs are designed to target cancer and a range of non-cancer chronic disease states, including autoimmune, neurological, and cardiovascular diseases. Results show that anti-cancer LVSCs ( = 75) typically require 5.0 to 20.0 mL doses every three weeks and are administered by healthcare professionals. In contrast, non-cancer LVSCs ( = 107), which are typically self-administered monthly, show more significant dosing variability, with < 5.0 mL being the predominant volume range. Furthermore, the study identified a substantial clinical pipeline of potential LVSCs, many of which are being injected at increasingly lower dosing frequencies, suggesting significant future growth in this area. Most non-cancer LVSCs are currently undergoing clinical trials via the SC route, whereas the majority of the cancer LVSCs are being administered IV and require transition to the SC route. These findings highlight the importance of developing large-volume drug delivery systems and novel formulations to reduce injection volumes. The analysis provides valuable guidance for new product development, as well as for marketing and commercialization strategies in the rapidly evolving LVSC landscape.
皮下注射正在改变生物制药的给药方式，为包括家庭自我治疗在内的各种医疗环境中的护理提供便利。大容量单次皮下注射剂量因其扩大治疗应用范围和改善以患者为中心的长期给药方案的潜力而受到关注，通常可降低皮下注射频率。然而，目前缺乏对大容量（>2.0 mL）皮下生物制药（LVSCs）的剂量体积和频率的系统认识。因此，本研究系统回顾了处于临床阶段以及已获批的静脉注射（IV）和皮下生物制药，识别出182种LVSCs——主要是单克隆或双特异性抗体——约占所有IV和皮下生物制药的15%。这些LVSCs旨在针对癌症和一系列非癌症慢性疾病状态，包括自身免疫性、神经和心血管疾病。结果表明，抗癌LVSCs（n = 75）通常每三周需要5.0至20.0 mL剂量，由医疗专业人员给药。相比之下，非癌症LVSCs（n = 107）通常每月自我给药，其剂量变异性更大，主要体积范围<5.0 mL。此外，该研究还发现了大量潜在LVSCs的临床研发管线，其中许多药物的注射频率越来越低，表明该领域未来将有显著增长。目前大多数非癌症LVSCs正在通过皮下途径进行临床试验，而大多数癌症LVSCs则通过静脉注射给药，需要过渡到皮下途径。这些发现凸显了开发大容量药物输送系统和新型制剂以减少注射体积的重要性。该分析为新产品开发以及快速发展的LVSC领域的营销和商业化策略提供了有价值的指导。
