O'Callaghan J, Barry S P, Bermingham M, Morris J M, Griffin B T
Regulatory Science Ireland, c/o School of Pharmacy, University College Cork, Cork, Ireland.
School of Pharmacy, University College Cork, Cork, Ireland.
Eur J Clin Pharmacol. 2019 Jan;75(1):1-11. doi: 10.1007/s00228-018-2542-1. Epub 2018 Sep 5.
Competition arising from the increasing availability of biosimilar medicines has resulted in healthcare savings and has provided greater patient access to high cost therapeutics in Europe. The biosimilar market in the USA is relatively new so the full impact of biosimilar availability remains to be seen. Educational initiatives relating to the use of biosimilar medicines are currently being undertaken by regulators, policy makers and industry. The debate on biosimilars has moved on from the appropriateness of the regulatory framework which governs their approval, to the practice of interchangeability. Interchangeability is an important issue for healthcare professionals but different definitions and regulatory frameworks exist in the USA and Europe. In the USA, an interchangeable biological product is a biosimilar which may be substituted by a pharmacist, subject to local State policies. The interchangeability of a biosimilar with its reference medicine will be evaluated by the United States Food and Drug Administration (FDA) in cases where approval as an 'interchangeable product' is sought. In contrast, the European Medicines Agency (EMA) does not assess or make recommendations on interchangeability, therefore, in Europe, interchangeability does not mean substitution but is generally physician-led or driven by national policy. This paper provides an overview of the regulation of biosimilar medicines. Challenges associated with the demonstration of interchangeability and practical considerations relating to switching are also discussed. Finally, we present policies that have been adopted to date in several European countries, the USA and Australia, which aim to promote the use of biosimilar medicines.
生物类似药可用性的不断提高所引发的竞争已带来了医疗保健成本的节省，并使欧洲患者有更多机会使用高成本治疗药物。美国的生物类似药市场相对较新，因此生物类似药可用性的全面影响仍有待观察。监管机构、政策制定者和行业目前正在开展与生物类似药使用相关的教育倡议。关于生物类似药的辩论已从管理其批准的监管框架的适当性，转向了可互换性的实践。可互换性对医疗保健专业人员来说是一个重要问题，但美国和欧洲存在不同的定义和监管框架。在美国，可互换生物制品是一种生物类似药，药剂师可根据当地州政策进行替代。在寻求作为“可互换产品”批准的情况下，美国食品药品监督管理局（FDA）将评估生物类似药与其参照药的可互换性。相比之下，欧洲药品管理局（EMA）不评估可互换性，也不就此提出建议，因此在欧洲，可互换性并不意味着替代，通常由医生主导或由国家政策推动。本文概述了生物类似药的监管情况。还讨论了与证明可互换性相关的挑战以及与换药相关的实际考虑因素。最后，我们介绍了美国、澳大利亚以及几个欧洲国家迄今为促进生物类似药的使用而采取的政策。
