Windisch J
Sandoz Biopharmaceuticals (a Novartis company), Biochemiestr. 10, 6250, Kundl, Österreich.
Z Rheumatol. 2015 Oct;74(8):672-81. doi: 10.1007/s00393-014-1486-9.
Due to the expiry of patents for biological pharmaceuticals, in forthcoming years there will be an increase in the approval of biosimilars by the international health authorities. This will bring potential savings in the range of 11.8-33.4 billion euros in the European Union (EU) in the year 2020.
The aims are an understanding of the natural variability of biological substances and the clinical relevance of the diverse product attributes, proof of comparability (similarity) as a self-contained concept in the development and approval of biosimilars and importance of extrapolation to other indications when comparability is demonstrated by comprehensive analytical and functional studies.
This study involved an assessment of the regulations of the European licensing authority, the European Medicines Agency (EMA), with respect to the approval of biosimilars, analytical, physicochemical and biological procedures for determination of comparability and the permissible deviation from the reference product
Approved biological pharmaceuticals have a natural intrinsic variability, e.g. with respect to glycosylation. Furthermore, different batches in the manufacturing process can be different or the manufacturing process itself can be subject to change. Biosimilars are subject to specific and strict approval criteria with the aim of restricting the product attributes to lie within the variability range of the original biologics, can only show deviations from the original preparations within very narrow limits and must show proven safety, quality and effectiveness comparable to them.
The development and approval concept of biosimilars has been proven for nearly 10 years. Strict requirements by the EMA guarantee the highest quality standards, which have led to significant savings in the healthcare system and an expansion of access to biological pharmaceuticals in many countries and for many patients.
由于生物制药专利到期，未来几年国际卫生当局批准的生物类似药将会增加。这将在2020年为欧盟带来118亿至334亿欧元的潜在节省。
目标是了解生物物质的自然变异性以及不同产品属性的临床相关性，证明可比性（相似性）作为生物类似药研发和批准中的一个独立概念，以及在通过全面分析和功能研究证明可比性时外推至其他适应症的重要性。
本研究涉及评估欧洲药品管理局（EMA）关于生物类似药批准的法规、用于确定可比性的分析、物理化学和生物学程序以及与参比产品允许的偏差。
已批准的生物制药具有自然的内在变异性，例如在糖基化方面。此外，生产过程中的不同批次可能不同，或者生产过程本身可能会发生变化。生物类似药要遵循特定且严格的批准标准，目的是将产品属性限制在原始生物制品的变异性范围内，只能在非常狭窄的限度内显示与原始制剂的偏差，并且必须显示出与它们相当的已证实的安全性、质量和有效性。
生物类似药的研发和批准概念已被验证近10年。EMA的严格要求保证了最高质量标准，这已在医疗保健系统中带来显著节省，并在许多国家和为许多患者扩大了获得生物制药的机会。
