Jahnz-Rozyk Karina, Wiesik-Szewczyk Ewa
Pol Merkur Lekarski. 2014 Jul;37(217):5-9.
The introduction of biologic therapies for treatment in many fields of medicine such as rheumatology oncology, dermatology, hematology and allergology, became one of the most important achievements of the modem medicine. The first biological therapeutics have already reached patent expiration date and corresponding biosimilars were approved by EMA (European Medicine Agency) and FDA (Food and Drug Administration). Many more biosimilar products are currently under review for marketing authorization around the world. The approval of products similar, but not identical to already known innovative biologics, due to complexity of structure and manufacturing technology, stirs a lot of discussions regarding safety concerns related to differences in posttranslational processing and in immunogenicity between reference and biosimilar products, and relevance of these differences to the clinical practice. Critical issues involve extrapolation to different clinical indication, automatic substitution and switching. Despite EMA recommendation and advocacy for biosimilars, it is beyond this regulatory authority to establish definitive regulation for each EU member, which it is expected to be country related. The aim of the study was an attempt to define the stance regarding particular aspects of biological treatment conducted in Poland is undertaken.
The Task Force of 13 experts involved in various aspects of biologic therapies in Poland was established. A modified Delphi voting was performed to achieve consensus regarding the most important aspects of biologic treatment in Poland, with particular concern of biosimilars.
Ten final statements were discussed and voted upon. The statements cover general aspects of biosimilars including expected cost-benefit ratios, extrapolation of clinical indications, interchange switching, patient information and requirement of patient consent. The state of post marketing pharmacovigilance of biologics (innovative ones as well as biosimilars) was also discussed.
The Task Force agreed that introduction of biosimilars is an important achievement in the biological therapies, with potential for reduction of treatment cost and increased treatment availability. Experts also agree that the safety of biological treatment should be monitored more carefully in Poland. Other discussed issues sparked more questions. There is no consensus among experts as to the automatic interchangeability of biosimilar and their innovative biopharmaceuticals. However, the switching might be acceptable in clinical practice on the case by case basis. There is an unmet need in Poland to create registry collecting data sufficient for assessment of safety and efficacy of both biosimilars and reference products in accordance with the experience and principles introduced in the European countries.
生物疗法在许多医学领域如风湿病学、肿瘤学、皮肤病学、血液学和变态反应学中的应用，已成为现代医学最重要的成就之一。首批生物治疗药物已到专利到期日，相应的生物类似药已获欧洲药品管理局（EMA）和美国食品药品监督管理局（FDA）批准。目前，还有更多生物类似药产品正在全球范围内接受上市许可审查。由于结构和生产技术复杂，与已知创新生物制剂相似但不完全相同的产品的获批，引发了许多关于参考产品和生物类似药之间翻译后加工及免疫原性差异相关的安全性问题的讨论，以及这些差异与临床实践的相关性。关键问题包括外推至不同临床适应症、自动替换和换药。尽管EMA对生物类似药提出了建议并予以倡导，但为每个欧盟成员国制定明确的法规超出了该监管机构的权限，这预计与国家相关。本研究的目的是试图确定波兰在生物治疗特定方面的立场。
成立了一个由13名参与波兰生物疗法各方面工作的专家组成的特别工作组。进行了一次改良的德尔菲投票，以就波兰生物治疗的最重要方面达成共识，尤其关注生物类似药。
讨论并表决了十条最终声明。这些声明涵盖生物类似药的一般方面，包括预期成本效益比、临床适应症的外推、互换换药、患者信息以及患者同意的要求。还讨论了生物制剂（创新生物制剂以及生物类似药）上市后药物警戒的状况。
特别工作组一致认为，生物类似药的引入是生物疗法中的一项重要成就，具有降低治疗成本和提高治疗可及性的潜力。专家们还一致认为，波兰应更仔细地监测生物治疗的安全性。其他讨论的问题引发了更多疑问。专家们对于生物类似药及其创新生物制药的自动互换性未达成共识。然而，在临床实践中，逐案换药可能是可以接受的。波兰存在未满足的需求，即需要根据欧洲国家引入的经验和原则创建一个登记处，收集足以评估生物类似药和参考产品安全性和有效性的数据。
