College of Pharmacy, University of South Carolina, Columbia, SC, USA; WJB Dorn VA Medical Center, Columbia, SC, USA; Department of Comparative Medicine and Evidence Based Medicine, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.
Saint Louis University School of Medicine, Saint Louis, MO, USA; John Cochran VA Medical Center, Saint Louis, MO, USA.
Lancet Oncol. 2020 Dec;21(12):e575-e588. doi: 10.1016/S1470-2045(20)30485-X.
The EU, the USA, and Japan account for the majority of biological pharmacotherapy use worldwide. Biosimilar regulatory approval pathways were authorised in the EU (2006), in Japan (2009), and in the USA (2015), to facilitate approval of biological drugs that are highly similar to reference products and to encourage market competition. Between 2007 and 2020, 33 biosimilars for oncology were approved by the European Medicines Agency (EMA), 16 by the US Food and Drug Administration (FDA), and ten by the Japan Pharmaceuticals and Medical Devices Agency (PMDA). Some of these approved applications were initially rejected because of manufacturing concerns (four of 36 [11%] with the EMA, seven of 16 [44%] with the FDA, none of ten for the PMDA). Median times from initial regulatory submission before approval of oncology biosimilars were 1·5 years (EMA), 1·3 years (FDA), and 0·9 years (PMDA). Pharmacists can substitute biosimilars for reference biologics in some EU countries, but not in the USA or Japan. US regulation prohibits substitution, unless the biosimilar has been approved as interchangeable, a designation not yet achieved for any biosimilar in the USA. Japan does not permit biosimilar substitution, as prescribers must include the product name on each prescription and that specific product must be given to the patient. Policy Reviews published in 2014 and 2016 in The Lancet Oncology focused on premarket and postmarket policies for oncology biosimilars before most of these drugs received regulatory approval. In this Policy Review from the Southern Network on Adverse Reactions, we identify factors preventing the effective launch of oncology biosimilars. Introduction to the market has been more challenging with therapeutic than for supportive care oncology biosimilars. Addressing region-specific competition barriers and educational needs would improve the regulatory approval process and market launches for these biologics, therefore expanding patient access to these products in the EU, the USA, and Japan.
欧盟、美国和日本占据了全球生物制药治疗方法的大部分使用份额。生物类似药监管审批途径在欧盟（2006 年）、日本（2009 年）和美国（2015 年）得到授权，以促进对与参比产品高度相似的生物药物的审批，并鼓励市场竞争。2007 年至 2020 年期间，欧洲药品管理局（EMA）批准了 33 种肿瘤学生物类似药，美国食品和药物管理局（FDA）批准了 16 种，日本药品和医疗器械管理局（PMDA）批准了 10 种。其中一些已批准的申请最初因制造方面的担忧而被否决（EMA 有 36 种中的 4 种[11%]，FDA 有 16 种中的 7 种[44%]，PMDA 没有）。从首次提交监管申请到批准肿瘤学生物类似药的中位数时间为 1.5 年（EMA）、1.3 年（FDA）和 0.9 年（PMDA）。在一些欧盟国家，药剂师可以用生物类似药替代参比生物制剂，但在美国或日本不行。美国法规禁止替代，除非生物类似药被批准为可互换，而在美国，还没有任何一种生物类似药获得这一指定。日本不允许生物类似药替代，因为医生必须在每张处方上注明产品名称，并且必须给患者使用该特定产品。《柳叶刀肿瘤学》于 2014 年和 2016 年发表的政策评论集中关注了大多数这类药物获得监管批准之前，肿瘤学生物类似药的上市前和上市后政策。在南方不良反应网络的这篇政策评论中，我们确定了阻碍肿瘤学生物类似药有效推出的因素。与支持性肿瘤学生物类似药相比，治疗性生物类似药进入市场更具挑战性。解决特定地区的竞争障碍和教育需求将改善这些生物制剂的监管审批流程和市场推出，从而扩大欧盟、美国和日本患者获得这些产品的机会。
