{"title":"Developing Biosimilars: Challenges and Opportunities.","authors":"Shubhadeep Sinha, Ruby Raphael","doi":"10.1007/s40290-025-00578-7","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"341-352"},"PeriodicalIF":4.5000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmaceutical Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1007/s40290-025-00578-7","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/7/30 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
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.
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.