Insulin Glargine(Mylan Nv)

The proposed legislation, which was reintroduced on June 4 by Sen. Mike Lee aims to remove the distinction between biosimilars and interchangeable biosimilars. As biosimilars struggle to live up to their promise of cutting costs and improving access to biologic medicines for U.S. patients, more than 39 advocacy groups are championing recent bipartisan efforts to cut through the bureaucracy that they believe has kept adoption at bay.The Association for Accessible Medicines (AAM) and the Biosimilars Council, alongside a clutch of advocacy organizations and healthcare provider groups like Public Citizen, the Academy of Managed Care Pharmacy and the Blue Cross Blue Shield Association, have voiced their support for the Biosimilar Red Tape Elimination Act in a letter sent (PDF) Tuesday to leaders of the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP).The proposed legislation, which was reintroduced on June 4 by Sen. Mike Lee, aims to remove the distinction between biosimilars and interchangeable biosimilars. The bipartisan bill was co-sponsored by Sens. Rand Paul, Maggie Hassan and Ben Ray Luján.“Interchangeability is a designation that doesn’t exist anywhere else in the world and there is no clinically meaningful difference between biosimilar and interchangeable biosimilar medicines,” John Murphy III, president and CEO of AAM, said in a release detailing the HELP committee letter. “The number of groups who’ve joined us in support of this bill shows how impactful cleaning up this confusion will be for patients.”Biosimilars are effectively just generic versions of biologic drugs, and a biosimilar that boasts an interchangeability tag can be substituted for the reference drug right at the pharmacy counter without additional doctor signoff.That said, the implementation of interchangeability in the U.S. market—which kicked off with the approval of Biocon and Viatris’ interchangeable insulin biosimilar Semglee in 2021—could be muddling treatment decisions and hampering uptake of the lower-cost medicines in the process, the Biosimilars Council, AAM and their co-signers wrote in the letter.By eliminating what the letter argues is an arbitrary distinction, the Biosimilar Red Tape Elimination Act would increase access to biosimilar drugs and reduce overall healthcare costs from branded biologics, the co-signers argued.Still, some groups within the industry are less eager to loosen restrictions around biosimilars. The Biosimilar Red Tape Elimination Act marks a "concerning departure" from the standards currently in place, Andrew Powaleny, spokesperson for the pharmaceutical industry trade group PhRMA, said in an emailed statement. "The bill would do away with important safeguards that protect patient safety without addressing the anticompetitive behavior by pharmacy benefit managers that block access to biosimilars and allow them to profit from medicines at the expense of patients," he argued. Biosimilars first hit the market in the U.S. in 2015 and have since generated savings of more than $36 billion in their use across more than 2.6 billion days of patient therapy, all while demonstrating no clinically meaningful differences in patient safety or health outcomes versus their reference drugs, according to AAM and the Biosimilars Council.Nevertheless, biosimilars have consistently struggled to gain traction in the U.S. when compared to the European market, despite the long-held expectation that they could lower costs and improve biologics access for American patients by increasing market competition, according to an article published last year in the American Journal of Managed Care (AJMC).The FDA was already well aware of the problem in 2019 when it released a report highlighting that U.S. biosimilar market share was lagging significantly behind trends seen in Europe. At the time, the regulator pinpointed several factors that may have contributed to sluggish biosimilar uptake, including reimbursement hurdles and a lack of interchangeability data.Aside from economic constraints, multiple industry watchers have pointed to the toll that interchangeability designations and other perception problems around biosimilars could be taking on their adoption in the U.S. By suggesting that only certain biosimilars are interchangeable with their reference drugs, the designation could imply—to both patients and doctors—that non-interchangeable biosimilars “might not meet safety or efficacy standards,” AJMC affiliate The Center for Biosimilars pointed out in an article on biosimilar use in oncology last summer.“The FDA has made clear that this arbitrary designation creates confusion, and that scientifically, biosimilars and interchangeables are not distinguishable,” Giuseppe Randazzo, SVP of sciences and regulatory affairs at the Biosimilars Council and AAM, said in Tuesday’s press release.AAM and the Biosimilars Council’s letter—which also included signatures from groups like Kaiser Permanente, the Allergy and Asthma Network and pharmacy benefit manager Prime Therapeutics—was addressed to Sens. Bill Cassidy, M.D., and Bernie Sanders, who serve as chair and ranking member of the Senate Health Committee, respectively, plus representatives Brett Guthrie and Frank Pallone. Sen. Lee originally introduced his biosimilar legislation in November 2022 in a bid to eliminate FDA requirements for switching studies—wherein patients alternate between a biosimilar and its reference biologic—to obtain interchangeable status and effectively make all approved biosimilar drugs interchangeable.“Our regulatory environment is making it too difficult and expensive for biosimilars to make it to the market,” Lee said at the time. “It’s the patients who suffer from a lack of competition and high drug prices.”Editor's note: This story has been updated with a statement from PhRMA. 

*本内容仅供医疗卫生专业人士阅读参考前言您的血糖管理跟上了吗？2型糖尿病（T2DM）患者的稳态控糖之旅犹如翻越万里长城，沿途布满了重重难关与挑战，每一步都考验着决心与智慧......FRC控糖小队再启新程！本期是“宁启新程·控糖有道——2025长城病例闯关赛”第五期，由上海交通大学医学院附属同仁医院黄珊教授担任守关人，由上海交通大学医学院附属同仁医院杜娟医生担任领队，带领FRC控糖小队来到了控糖挑战第五关倒马关......（照例，文末互动哦~）他们能否闯关成功？Some days later根据FRC控糖小队的降糖方案，降糖效果到底如何呢？那么，FRC控糖小队在杜医生的带领下能否顺利通关，拿到通关令牌？一起来看看守关人黄珊教授怎么说~守关人本关卡极具挑战性，患者血糖失控、体重增加，还伴有多种心肾合并症，治疗难度颇高。而FRC控糖小队凭借精准的甘精利司联合方案，不仅有效平稳地控制了血糖，更实现了CKM综合征的改善以及胰岛功能的部分恢复，全方位的治疗效果令人叹服！心血管-肾脏-代谢综合征（CKM）是近年学界提出的新概念，强调对CKM综合征的综合管理，实现糖心肾的综合获益[3]。研究显示，早期使用胰岛素治疗使患者血糖达标，可显著降低冠状动脉粥样硬化性心脏病（CHD）、心力衰竭（HF）住院及卒中风险[4]。而且，与序贯疗法相比，早期联合疗法可提升治疗效果，推动患者长期血糖达标，实现“Treat to success”[5]。在此背景下，国内外指南也越来越强调，不同作用机制药物早期联合治疗的重要性[1-2]，特别是在《中国糖尿病防治指南（2024版）》中[1]首次将基础胰岛素/GLP-1RA固定比例复方制剂（FRC）作为胰岛素治疗的起始推荐。甘精利司作为FRC的突出代表，一针双效、兼顾FPG与PPG控制，尤其是对PPG的控制具有显著优势，在早期控糖中发挥重要作用。机制层面：甘精利司由甘精胰岛素和利司那肽组合而成，其中甘精胰岛素：通过减少糖异生，减少肝糖的过度生成，从而降低FPG；利司那肽：通过葡萄糖依赖性促进胰岛素释放、抑制胰高血糖素分泌、延缓胃排空，强效控制PPG漂移[6]。疗效层面：LixiLan-O-AP[7]研究纳入以中国人群为主的亚太地区成人受试者，经口服降糖药（OADs）治疗血糖控制不佳添加甘精利司治疗，HbA1c降幅高达1.9%，HbA1c达标率近80%，显著优于添加甘精胰岛素或利司那肽治疗组。SoliD磐石研究[8]完全纳入OADs治疗血糖控制不佳的中国T2DM患者，与德谷门冬相比，甘精利司自基线至24周的HbA1c降幅达到了非劣效与优效，两组差值-0.2%，具有统计学意义；在FPG降幅相当的情况下，甘精利司三餐后平均血糖较德谷门冬进一步下降25%。此外，甘精利司较德谷门冬总体低血糖事件率减少29%，并实现-1.5 kg的体重获益。因此，OADs疗效不佳时，早期使用FRC药物可高效控糖达标，减少体重增加与低血糖，兼顾临床结局，强化心肾保护，提升依从性，保障治疗持久有效，实现T2DM综合优化管理。最后，恭喜大家顺利通过本关授予稳态控糖之旅“倒马关”通关令牌！前路平型关，血糖暗流涌动望与宁同行，稳扎稳打破难关“倒马关”闯关互动扫描二维码进入签到并答题（连续集齐6期通关令牌，即可赢取学术好礼）参考文献：（上下滑动查看更多）[1]中华医学会糖尿病学分会. 中国糖尿病防治指南（2024版）. 中华糖尿病杂志，2025，17(01):16-139. DOI:10.3760/cma.j.cn115791-20241203-00705.[2]ADA. Diabetes Care 2024;47(Supplement_1):S1–S321.[3]Ndumele CE, Neeland IJ, Tuttle KR, et al. A Synopsis of the Evidence for the Science and Clinical Management of Cardiovascular-Kidney-Metabolic (CKM) Syndrome: A Scientific Statement From the American Heart Association. Circulation. 2023 Nov 14;148(20):1636-1664. doi: 10.1161/CIR.0000000000001186. Epub 2023 Oct 9. PMID: 37807920.[4]Luo S, Zheng X, Bao W,  et al. Real-world effectiveness of early insulin therapy on the incidence of cardiovascular events in newly diagnosed type 2 diabetes. Signal Transduct Target Ther. 2024 Jun 6;9(1):154. doi: 10.1038/s41392-024-01854-9. PMID: 38844816; PMCID: PMC11156919.[5]Del Prato S, Felton AM, Munro N, et al. Improving glucose management: ten steps to get more patients with type 2 diabetes to glycaemic goal. Int J Clin Pract. 2005 Nov;59(11):1345-55. doi: 10.1111/j.1742-1241.2005.00674.x. PMID: 16236091.[6]Hinnen D, Strong J. iGlarLixi: A New Once-Daily Fixed-Ratio Combination of Basal Insulin Glargine and Lixisenatide for the Management of Type 2 Diabetes. Diabetes Spectr. 2018 May;31(2):145-154. doi: 10.2337/ds17-0014. PMID: 29773934; PMCID: PMC5951239.[7]Yang W, Dong X, Li Q, et al. Efficacy and safety benefits of iGlarLixi versus insulin glargine 100 U/mL or lixisenatide in Asian Pacific people with suboptimally controlled type 2 diabetes on oral agents: The LixiLan-O-AP randomized controlled trial. Diabetes Obes Metab. 2022 Aug;24(8):1522-1533. doi: 10.1111/dom.14722. Epub 2022 May 12. PMID: 35441412.[8]Liu M, Gu W, Chen L, et al. The efficacy and safety of iGlarLixi versus IDegAsp in Chinese people with type 2 diabetes suboptimally controlled with oral antidiabetic drugs: The Soli-D randomized controlled trial. Diabetes Obes Metab. 2024 Sep;26(9):3791-3800. doi: 10.1111/dom.15724. Epub 2024 Jun 22. PMID: 38922731.专家简介黄珊 教授上海交通大学医学院附属同仁医院上海交通大学医学院附属同仁医院内分泌科主任 医学博士、主任医师、研究生导师上海市长宁区领军人才、内分泌硕博创新人才基地负责人上海市医学会内分泌学会、医师协会会委员上海市内分泌学会肾上腺学组副组长上海市中西医结合内分泌代谢分会常委白求恩精神研究会内分泌代谢肾上腺学会常委              中国初级保健基金会内分泌代谢专委会委员上海市糖尿病康复学会委员上海市科普作家学会委员、评审专家上海交通大学医学院优秀导师、“三八”红旗手杜娟 医生上海交通大学医学院附属同仁医院上海交通大学医学院附属同仁医院内分泌科医学博士、主治医师  上海中西医结合分会糖尿病及并发症专委会青年委员白求恩精神研究会内分泌和糖尿病学会青年委员参与国家自然科学基金、市级课题共5项承担上海市同仁医院院级课题3项承担“同仁新星”人才项目以第一或共一作者发表SCI及核心期刊论文10余篇参编协和《代谢性骨病》声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。MAT-CN-2511341最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《国际糖尿病》编辑部）版权声明版权属《国际糖尿病》所有。欢迎个人转发分享。其他任何媒体、网站未经授权，禁止转载。