生物疗法已经改变了高负担治疗。随着生物药物的专利和独占期接近尾声,生物仿制药的开发和授权是有可能的。这些产品拥有可比的安全水平,质量,以及对其前体参考产品的有效性。生物仿制药,虽然与参考产品相似,不是相同的副本,不应被视为原件的通用替代品。它们的开发和评估涉及严格的逐步过程,包括分析,功能,以及非临床评估和临床试验。对生物仿制药进行的临床研究旨在建立相似的疗效,安全,和免疫原性,而不是证明临床益处,与参考产品一样。然而,尽管目前关于生物仿制药的知识已经大大增加,关于它们的免疫原性仍然存在一些争议和误解,外推,互换性,替换,和命名法。生物仿制药的发展刺激了市场竞争,有助于医疗保健的可持续性,并允许更多的患者进入。然而,最大限度地提高生物仿制药的效益需要监管机构和开发商之间的合作,以确保患者能够从获得这些新的治疗替代品中迅速受益,同时保持高标准的质量,安全,和功效。认识到充分理解生物仿制药的内在复杂性,必须注重现实的方法,例如促进医疗保健提供者和患者之间的开放沟通,鼓励知情决策,最小化风险。这篇综述解决了生物仿制药的监管和制造要求,并为临床医生提供了有关知情处方的相关见解。
Biological therapies have transformed high-burden treatments. As the patent and exclusivity period for biological medicines draws to a close, there is a possibility for the development and authorization of
biosimilars. These products boast comparable levels of safety, quality, and effectiveness to their precursor reference products.
Biosimilars, although similar to reference products, are not identical copies and should not be considered generic substitutes for the original. Their development and evaluation involve a rigorous step-by-step process that includes analytical, functional, and nonclinical evaluations and clinical trials. Clinical studies conducted for
biosimilars aim to establish similar efficacy, safety, and immunogenicity, rather than demonstrating a clinical benefit, as with the reference product. However, although the current knowledge regarding biosimilars has significantly increased, several controversies and misconceptions still exist regarding their immunogenicity, extrapolation, interchangeability, substitution, and nomenclature. The development of biosimilars stimulates market competition, contributes toward healthcare sustainability, and allows for greater patient access. However, maximizing the benefits of
biosimilars requires cooperation between regulators and developers to ensure that patients can benefit quickly from access to these new therapeutic alternatives while maintaining high standards of quality, safety, and efficacy. Recognizing the inherent complexities of comprehending
biosimilars fully, it is essential to focus on realistic approaches, such as fostering open communication between healthcare providers and patients, encouraging informed decision-making, and minimizing risks. This review addresses the regulatory and manufacturing requirements for biosimilars and provides clinicians with relevant insights for informed prescribing.