关于生物制剂

关于生物制剂

生物制剂已经彻底改变了许多致残和威胁生命的疾病的治疗与预防。生物类似药是专利已过期且独占性已消失的现有生物制剂的后续药品。

生物制剂

生物药品的开发过程十分复杂,因为它们是由生物体、组织或细胞制造或提取而成的。1这些药品为治疗和预防内分泌学、肿瘤学、免疫学、眼科和皮肤病学等领域的许多致残和威胁生命的疾病带来了革命性的变化。1

然而,由于开发和供应这些药物很复杂,生物制剂正在推动医疗成本的上升,这可能会限制病人获得可能拯救生命的治疗。2

与参比制剂一样安全和有效,且更可负担的药品选择,为医疗系统提供了机会,使更多的患者能够获得生物制剂,释放资源以投资于新领域,并缓解医疗预算的压力。

生物类似药

生物类似药是一种生物药品(也称为 "参比制剂")的后续产品,其专利权已经过期,独占性已经丧失3,4

要获准使用,生物类似药必须在质量、安全和疗效方面与参考制剂相匹配,并证明没有临床意义上的差异。这是基于 "整体证据 "的概念,使用先进的分析和临床研究。5,6 在此了解更多关于生物仿制药的发展。

根据各国医疗机构实施的政策和制度,生物仿制药有可能改善患者面临的可及性挑战,为医疗系统节省成本,并为医疗专业人士增加治疗选择。

患者的利益

引入高质量、可负担的生物类似药可以扩大全世界患者获得可能改变生命的药物的机会。7

生物类似药引入竞争,从而推动创新,如加强现有药物和开发新的治疗方法。8

付方的利益

生物类似药引发竞争,提高了生物制剂的可负担性,为医疗系统节省了资金,有助于释放资源,用于改善护理条件和资助下一代药物开发。

据估计,在2021年至2025年期间,生物类似药可在全球范围内累计节省2800亿欧元的成本。9

医护人员的利益

生物类似药的引入推动了竞争,从而增加了治疗选择和增值服务,以支持病患护理和医疗社区建设。

2021年至2029年期间,将有超过120种生物药品失去独占性——是过去十年中失去专利的生物药品数量的两倍。10

  1. European Medicines Agency and European Commission. Biosimilars in the EU: information guide for healthcare professionals. 2019. Available from: Biosimilars in the EU - Information guide for healthcare professionals (europa.eu) [Accessed October 2021].
  2. Dutta, B., et al. Identifying Key Benefits in European Off-Patent Biologics and Biosimilar Markets: It is Not Only About Price! BioDrugs (2019)
  3. Weise M, et al. Biosimilars: what clinicians should know. Blood 2012;120:5111-7
  4. Kay J. A ‘wind of change’ to biosimilars: the NOR-SWITCH trial and its extension. J Intern Med. 2019;285:693-5.
  5. European Commission. Consensus Information Paper 2013. What you need to know about Biosimilar Medicinal Products. Available from: biosimilars_report_en.pdf (medicinesforeurope.com) [Accessed October 2021]
  6. Food and Drug Administration. Information on Biosimilars. Available from: Slide 1 (fda.gov) [Accessed October 2021]
  7. National Institute for Health and Care Excellence. NICE recommends several treatment options to help thousands with moderate rheumatoid arthritis. June 2021.Available from: NICE recommends several treatment options to help thousands with moderate rheumatoid arthritis | News and features | News | NICE [Accessed October 2021]
  8. Vulto AG, et al. The Efficacy, Safety, and Immunogenicity of Switching Between Reference Biopharmaceuticals and Biosimilars: A Systematic Review. Clin Pharmacol Ther. 2020 Oct; 108(4): 734-755
  9. Yahoo! Finance. Global Medicine Spending to Reach $1.6 trillion in 2025 Excluding Spending on COVID-19 Vaccines, According to IQVIA Institute for Human Data Science Study. Available from: Global Medicine Spending to Reach $1.6 Trillion in 2025 Excluding Spending on COVID-19 Vaccines, According to IQVIA Institute for Human Data Science Study (yahoo.com) [Accessed October 2021]
  10. IQVIA Institute for Human Data Science. The Impact of Biosimilar Competition in Europe. Available from: https://www.iqvia.com/-/media/iqvia/pdfs/emea/the-impact-of-biosimilar-competition-in-europe-iqvia.pdf [Accessed October 2021]

Source URL: https://www.sandoz.com.cn/our-work/biopharmaceuticals/about-biologics

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