Woroń Jaroslaw, Kocić Ivan
Pol Merkur Lekarski. 2014 Nov;37(221):311-5.
Patent protection on some key biologic drugs is going to expire soon. Therefore, chances are rising for biopharmaceutical manufacturers to develop and market biosimilars (follow-on biologics). These drugs are approved when similarity to reference biological medicine is proven: in terms of quality, safety or efficacy. In September 2013 European Medicines Agency authorized the first biosimilar monoclonal antibody-infliximab. Doubts considering follow-on biologics are related to their safety and efficacy. The majority of them are associated with the new phenomenon for biological products in clinical use and drug approval processes. These are: extrapolation of indications, immunogenicity and interchangeability. The case of interchangeability poses a threat that it would be impossible to determine which drug is responsible for adverse event, even if brand names and batch numbers of reference and biosimilar products are known. Biosimilar product is authorized if it has shown efficacy and safety in some of indications. When approved, its use will be extrapolated on other indications of the reference product. The aim of following article is to describe some current issues on biosimilars safety, approval procedures and legal solutions in Poland.
一些关键生物药物的专利保护即将到期。因此，生物制药制造商开发和销售生物类似药（后续生物制品）的机会正在增加。当证明与参考生物药物在质量、安全性或有效性方面相似时，这些药物会获得批准。2013年9月，欧洲药品管理局批准了首个生物类似单克隆抗体——英夫利昔单抗。对后续生物制品的疑虑涉及其安全性和有效性。其中大多数与生物制品在临床使用和药物审批过程中的新现象有关。这些现象包括：适应症外推、免疫原性和可互换性。可互换性的情况带来了一种威胁，即即使知道参考产品和生物类似产品的品牌名称和批号，也无法确定哪种药物导致了不良事件。如果生物类似产品在某些适应症中显示出疗效和安全性，它将获得批准。获批后，其用途将外推至参考产品的其他适应症。本文的目的是描述波兰目前在生物类似药安全性、审批程序和法律解决方案方面的一些问题。
