Department of Pharmacy, Northwestern Medicine, Chicago, IL, USA.
Department of Pharmacy, University of Chicago Medicine, Chicago, IL, USA.
Am J Health Syst Pharm. 2023 Sep 7;80(18):1223-1233. doi: 10.1093/ajhp/zxad120.
The impact of the market entry of adalimumab biosimilars on clinical practices and specialty pharmacies is explained. A roadmap is also provided for how pharmacists can successfully navigate this landscape.
Biosimilars have previously been introduced as a mechanism to help curb biologic expenditures, with biosimilars undergoing an abbreviated regulatory approval process that focuses on biosimilarity and generating product competition. Adalimumab is currently the leading product in the biologics market, generating approximately $20 to $30 billion in sales worldwide consecutively from 2019 to 2021. Many adalimumab biosimilars are slated to enter the market in 2023 and become available for patient use. However, compared to other biosimilars, adalimumab biosimilars have several unique considerations, such as interchangeability and concentration, that will impact pharmacy practices and workflows. Because pharmacists embedded in clinical practices and specialty pharmacies will be significantly involved in the processes relating to adalimumab biosimilar implementation, adoption, and use, a primer on understanding the various adalimumab biosimilar products available and considerations surrounding these products with regard to workflow and patient use is critical. Several resources are also provided to help pharmacists successfully navigate the adalimumab biosimilar landscape.
The biosimilar landscape continues to evolve, and 2023 will see the launch of several adalimumab biosimilar products, which vary with regard to formulation, concentration, and interchangeability status. Pharmacists are well positioned to educate providers and patients about this landscape and help implement an efficient workflow to support adalimumab biosimilar adoption and use.
解释阿达木单抗生物类似药进入市场对临床实践和专科药房的影响。还提供了一份路线图,说明药剂师如何成功应对这一局面。
生物类似药以前是作为一种帮助控制生物制剂支出的机制引入的,生物类似药的监管审批程序较为简化,重点是生物类似性和产品竞争。阿达木单抗目前是生物制品市场的领先产品,2019 年至 2021 年连续三年在全球的销售额约为 200 亿至 300 亿美元。许多阿达木单抗生物类似药计划于 2023 年进入市场,可供患者使用。然而,与其他生物类似药相比,阿达木单抗生物类似药有几个独特的考虑因素,如可互换性和浓度,这将影响药房的实践和工作流程。由于临床实践和专科药房中的药剂师将在与阿达木单抗生物类似药实施、采用和使用相关的过程中发挥重要作用,因此了解可用的各种阿达木单抗生物类似药产品以及与这些产品相关的工作流程和患者使用方面的注意事项至关重要。还提供了一些资源,以帮助药剂师成功应对阿达木单抗生物类似药领域。
生物类似药领域继续发展,2023 年将推出几种阿达木单抗生物类似药产品,这些产品在制剂、浓度和可互换性方面存在差异。药剂师在教育提供者和患者了解这一领域并帮助实施高效的工作流程以支持阿达木单抗生物类似药的采用和使用方面具有独特的优势。