{"title":"新兴的自有品牌市场准入渠道将有助于还是阻碍生物仿制药市场准入?","authors":"Stanton R Mehr","doi":"10.18553/jmcp.2025.31.8.824","DOIUrl":null,"url":null,"abstract":"<p><p>Until April 2024, adalimumab biosimilar uptake remained stagnant at 2% to 3%; the 3 largest pharmacy benefit managers (PBMs), which control 80% of prescriptions dispensed in the United States, maintained the reference product on formulary. That month, a major PBM changed its adalimumab formulary coverage policy, preferring 2 private-label biosimilars and 1 branded biosimilar, while excluding the reference product. The private-label biosimilar approach has since been adopted by the other 2 major PBMs, offering promise for biosimilar uptake, but seemingly only under the terms of the private-label arrangements. These arrangements may pose additional transparency issues for payers and plan sponsors, as well as barriers to biosimilar competition. The concerns raised by the emergence of the private-label channel apply not only to the adalimumab category but to ustekinumab and future biosimilars covered under the pharmacy benefit. Stakeholders concerned with biosimilar sustainability should monitor this situation as it continues to unfold for its effects on competition, conflicts of interest, and future biosimilar development.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 8","pages":"824-827"},"PeriodicalIF":2.9000,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288720/pdf/","citationCount":"0","resultStr":"{\"title\":\"Will the emerging private-label market access channel help or hinder biosimilar market access?\",\"authors\":\"Stanton R Mehr\",\"doi\":\"10.18553/jmcp.2025.31.8.824\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Until April 2024, adalimumab biosimilar uptake remained stagnant at 2% to 3%; the 3 largest pharmacy benefit managers (PBMs), which control 80% of prescriptions dispensed in the United States, maintained the reference product on formulary. That month, a major PBM changed its adalimumab formulary coverage policy, preferring 2 private-label biosimilars and 1 branded biosimilar, while excluding the reference product. The private-label biosimilar approach has since been adopted by the other 2 major PBMs, offering promise for biosimilar uptake, but seemingly only under the terms of the private-label arrangements. These arrangements may pose additional transparency issues for payers and plan sponsors, as well as barriers to biosimilar competition. The concerns raised by the emergence of the private-label channel apply not only to the adalimumab category but to ustekinumab and future biosimilars covered under the pharmacy benefit. Stakeholders concerned with biosimilar sustainability should monitor this situation as it continues to unfold for its effects on competition, conflicts of interest, and future biosimilar development.</p>\",\"PeriodicalId\":16170,\"journal\":{\"name\":\"Journal of managed care & specialty pharmacy\",\"volume\":\"31 8\",\"pages\":\"824-827\"},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2025-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288720/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of managed care & specialty pharmacy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.18553/jmcp.2025.31.8.824\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"HEALTH CARE SCIENCES & SERVICES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of managed care & specialty pharmacy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.18553/jmcp.2025.31.8.824","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
Will the emerging private-label market access channel help or hinder biosimilar market access?
Until April 2024, adalimumab biosimilar uptake remained stagnant at 2% to 3%; the 3 largest pharmacy benefit managers (PBMs), which control 80% of prescriptions dispensed in the United States, maintained the reference product on formulary. That month, a major PBM changed its adalimumab formulary coverage policy, preferring 2 private-label biosimilars and 1 branded biosimilar, while excluding the reference product. The private-label biosimilar approach has since been adopted by the other 2 major PBMs, offering promise for biosimilar uptake, but seemingly only under the terms of the private-label arrangements. These arrangements may pose additional transparency issues for payers and plan sponsors, as well as barriers to biosimilar competition. The concerns raised by the emergence of the private-label channel apply not only to the adalimumab category but to ustekinumab and future biosimilars covered under the pharmacy benefit. Stakeholders concerned with biosimilar sustainability should monitor this situation as it continues to unfold for its effects on competition, conflicts of interest, and future biosimilar development.
期刊介绍:
JMCP welcomes research studies conducted outside of the United States that are relevant to our readership. Our audience is primarily concerned with designing policies of formulary coverage, health benefit design, and pharmaceutical programs that are based on evidence from large populations of people. Studies of pharmacist interventions conducted outside the United States that have already been extensively studied within the United States and studies of small sample sizes in non-managed care environments outside of the United States (e.g., hospitals or community pharmacies) are generally of low interest to our readership. However, studies of health outcomes and costs assessed in large populations that provide evidence for formulary coverage, health benefit design, and pharmaceutical programs are of high interest to JMCP’s readership.