Drug Ther Bull. 2013 May;51(5):57-60. doi: 10.1136/dtb.2013.5.0181.
All prescribers will be familiar with the issues associated with the use of branded and generic 'chemical' medicines.(1) For biological products (e.g. epoetin, filgrastim), a biosmilar medicine is a new biological product that is similar to a medicine that has already been authorised to be marketed in the EU (the biological reference medicine).(2) Six biosimilar medicinal products are currently marketed in the UK-three versions of filgrastim (▾Nivestim, ▾Tevagrastim and Zarzio),(3-5) two versions of epoetin (Binocrit and Retacrit)(6,7) and one version of somatropin (Omnitrope).(8) Applications for biosimilar versions of follitropin alfa and infliximab are under evaluation by the European Medicine's Agency (EMA) Committee for Medicinal Products for Human Use.(9) In the future there may also be biosimilar versions of insulins, recombinant vaccines, interferons and monoclonal antibodies such as rituximab and trastuzumab.(10) It is estimated that about 50% of the current UK market for biological medicines by spend may be subject to biosimilar competition by 2019. In this article, we will consider the background to developing biosimilar medicines, how and why they differ from traditional generic medicines in their licensing requirements and the issues that may arise as they are introduced to clinical practice.
所有开处方者都熟悉使用品牌和通用“化学”药物相关的问题。（1）对于生物制品（如促红细胞生成素、非格司亭），生物类似药是一种新型生物制品，与已在欧盟获批上市的药品（生物参比药品）相似。（2）目前有六种生物类似药在英国上市——三种非格司亭制剂（▾尼沃思亭、▾特伐格拉司亭和扎尔齐奥），（3 - 5）两种促红细胞生成素制剂（比诺克瑞和瑞他停），（6,7）以及一种生长激素制剂（奥曲肽）。（8）促卵泡素α和英夫利昔单抗生物类似药的申请正在由欧洲药品管理局（EMA）人用药品委员会评估。（9）未来可能还会有胰岛素、重组疫苗、干扰素以及诸如利妥昔单抗和曲妥珠单抗等单克隆抗体的生物类似药。（10）据估计，到2019年，按支出计算，英国目前生物药品市场中约50%可能会面临生物类似药的竞争。在本文中我们将探讨生物类似药研发的背景、它们在许可要求方面与传统仿制药的不同方式及原因，以及在引入临床实践时可能出现的问题。
