Developing Biosimilars: Challenges and Opportunities.

IF 4.5 Q2 PHARMACOLOGY & PHARMACY
Pharmaceutical Medicine Pub Date : 2025-09-01 Epub Date: 2025-07-30 DOI:10.1007/s40290-025-00578-7
Shubhadeep Sinha, Ruby Raphael
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引用次数: 0

Abstract

The global pharmaceutical landscape is undergoing a profound shift with the rise of biosimilars-biologic medical products that are highly similar to original biologics but manufactured by different companies. Biological therapies encompass a range of therapies, including hormones such as insulin and growth hormone, vaccines, erythropoietin (EPO), monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), and bispecific antibodies (BsAbs), etc. As patents for many blockbuster biologic drugs expire, biosimilars provide an opportunity to improve patient access to life-saving treatments while potentially lowering healthcare costs, especially in regions with high unmet medical needs. However, the development and integration of biosimilars into mainstream healthcare comes with various challenges, including regulatory approval processes, ensuring quality, potency, efficacy, immunogenicity, safety, and overcoming market resistance. In this article, we will explore the development of biosimilars in-depth, their approval pathways, benefits, and the hurdles in achieving widespread adoption.

发展生物仿制药:挑战与机遇。
随着生物仿制药的兴起,全球制药业正在经历一场深刻的变化。生物仿制药是指与原始生物制剂高度相似但由不同公司生产的生物医疗产品。生物疗法包括一系列的疗法,包括胰岛素和生长激素等激素、疫苗、促红细胞生成素(EPO)、单克隆抗体(mab)、抗体-药物偶联物(adc)和双特异性抗体(bsab)等。随着许多重磅生物药物的专利到期,生物仿制药为改善患者获得挽救生命的治疗提供了机会,同时有可能降低医疗成本,特别是在医疗需求未得到满足的地区。然而,将生物仿制药开发和整合到主流医疗保健中面临着各种挑战,包括监管审批流程、确保质量、效力、功效、免疫原性、安全性以及克服市场阻力。在本文中,我们将深入探讨生物仿制药的发展、它们的批准途径、益处以及实现广泛采用的障碍。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Pharmaceutical Medicine
Pharmaceutical Medicine PHARMACOLOGY & PHARMACY-
CiteScore
5.10
自引率
4.00%
发文量
36
期刊介绍: Pharmaceutical Medicine is a specialist discipline concerned with medical aspects of the discovery, development, evaluation, registration, regulation, monitoring, marketing, distribution and pricing of medicines, drug-device and drug-diagnostic combinations. The Journal disseminates information to support the community of professionals working in these highly inter-related functions. Key areas include translational medicine, clinical trial design, pharmacovigilance, clinical toxicology, drug regulation, clinical pharmacology, biostatistics and pharmacoeconomics. The Journal includes:Overviews of contentious or emerging issues.Comprehensive narrative reviews that provide an authoritative source of information on topical issues.Systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by PRISMA statement.Original research articles reporting the results of well-designed studies with a strong link to wider areas of clinical research.Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pharmaceutical Medicine may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.All manuscripts are subject to peer review by international experts. Letters to the Editor are welcomed and will be considered for publication.
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