The current perspective reviews the biopharmaceutical market until end of 2020 and highlights the transforming biopharmaceutical landscape during the recent decade. In particular, the rise of biosimilars and the development of new therapeutic modalities through recent advancement in molecular biology research sustainably change the product scenery. The present manuscript describes opportunities for pharmaceutical technical development, highlighting concepts such as product differentiation to succeed in a competitive product landscape. Product differentiation offers the opportunity for numerous life-cycle options and market exclusivity through incremental improvements in standard of care treatment. In particular, different formulation options and formulation-device combinations are described, focusing on systemic delivery of monoclonal antibody products and patient-centered development. The concept of product differentiation is exemplified in a case study about HER2+ breast cancer therapy, underlining pharmaceutical technical solutions and major improvements for the patient.

当前的观点回顾了 2020 年底之前的生物制药市场，并突出了最近十年生物制药格局的转变。特别是，生物仿制药的兴起和通过分子生物学研究的最新进展开发的新治疗方式可持续地改变了产品的格局。本手稿描述了制药技术发展的机会，强调了产品差异化等概念，以在竞争激烈的产品领域取得成功。通过逐步改进护理标准，产品差异化为众多生命周期选择和市场独占性提供了机会。特别地，描述了不同的配方选项和配方-装置组合，专注于单克隆抗体产品的系统交付和以患者为中心的开发。产品差异化的概念在一个关于 HER2+ 乳腺癌治疗的案例研究中得到了例证，强调了制药技术解决方案和对患者的重大改进。