A Phase 4, Double Blind, Single Center, Randomized, Cross-Over Study of Continuous Subcutaneous Insulin Infusion (CSII) Pump Functionality in Subjects With Type 1 Diabetes Comparing Pretreatment vs. No Pretreatment With Recombinant Human Hyaluronidase (rHuPH20)

The goal of this study is to determine if Hylenex recombinant leads to changes in the insulin time-action profiles and glucose responses when preadministered in the setting of continuous subcutaneous insulin infusion (CSII) compared to CSII without Hylenex recombinant (sham injection).

开始日期2013-10-03

申办/合作机构

Halozyme Therapeutics, Inc.

NCT01275131

/ Completed临床1期

Randomized, Double-Blind, Pharmacokinetic (PK) and Glucodynamic (GD) Crossover Study of Continuous Subcutaneous Insulin Infusion (CSII) of Rapid Acting Insulin Analogs With and Without Recombinant Human Hyaluronidase (rHuPH20)

The purpose of this study is to determine if recombinant human hyaluronidase PH20 (rHuPH20) will change the exposure and action of approved insulin analogs when given by continuous subcutaneous insulin infusion (CSII) in participants with Type 1 diabetes mellitus (T1DM).
This study is divided into Stage 1, 2, and 3. Stage 3 was started chronologically before Stage 2 and, prior to performing Stage 2, the Sponsor made the decision to terminate Stage 2. Stage 2 was not initiated due to a strategic business decision and termination was not based on safety or efficacy concerns. No participants were enrolled in Stage 2.

开始日期2011-01-01

申办/合作机构

Halozyme Therapeutics, Inc.

NCT01194245

/ Completed临床2期

A Phase II, Randomized, Double Blind, 2-Way Crossover Safety and Efficacy Study of Subcutaneously Injected Prandial Insulins: Lispro-PH20 or Aspart-PH20 Compared to Insulin Lispro (Humalog®) in Patients With Type 1 Diabetes

The purpose of the study is to compare Humalog (Insulin lispro)-recombinant human hyaluronidase (rHuPH20) or Novolog (Insulin aspart)-rHuPH20 to Humalog (Insulin lispro) for the treatment of Type 1 Diabetes Mellitus (T1DM) in basal-bolus therapy.

开始日期2010-08-01

申办/合作机构

Halozyme Therapeutics, Inc.

100 项与 Insulins(Halozyme) 相关的临床结果

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100 项与 Insulins(Halozyme) 相关的转化医学

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100 项与 Insulins(Halozyme) 相关的专利（医药）

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项与 Insulins(Halozyme) 相关的文献（医药）

2025-12-01·JOURNAL OF AFFECTIVE DISORDERS

Updated insights on memory disorder associated risk of medication: A real-world pharmacovigilance analysis

Article

作者: Chen, Quanshun ; Zhu, Hong ; Mao, Mingyang ; Yu, Qing ; Wang, Mei ; Yang, Yi ; Wan, Tao ; Zhao, Jie

OBJECTIVE:

This study aims to use the Food and Drug Administration Adverse Event Reporting System (FAERS) to identify medications linked to memory disorders and to offer updated insights into medication-induced memory disorders.

METHODS:

We analyzed adverse event (AE) reports related to memory disorders in the FAERS database from 2004 to 2023 and compiled a list of potential medications along with their associated AEs. The disproportionality analysis was employed to assess the potential associations between medications and memory disorder events.

RESULTS:

The study identified 194,754 memory-related AEs in the FAERS database, revealing a higher prevalence in females (62.11 %) compared to males (32.76 %). A comprehensive medication list was summarized, comprising 374 potential medications that may contribute to memory disorders. The top 50 medications linked to memory impairment, amnesia, and dementia have been compiled and categorized accordingly. Overall, immunosuppressants represented the medication category with the highest incidence of AEs, followed by immunostimulants, other analgesics and antipyretics, antiepileptics, insulins, antidepressants, angiotensin II receptor blockers, antipsychotics, and lipid-modifying agents. The median time-to-onset (TTO) of memory-related AEs was 59 days (interquartile range [IQR] 1-503), with most medications exhibiting early failure types as determined by the Weibull shape parameter (WSP) analysis. The medications most frequently linked to memory disorders in minors were montelukast, atomoxetine, methylphenidate, lamotrigine, zanamivir, and somatropin.

CONCLUSIONS:

This study presents a comprehensive overview of medications that induce memory disorder from a pharmacovigilance perspective, may offering certain references for clinical practice. However, further research is required necessary to elucidate these associations.

2025-10-01·LANCET

The future of type 1 diabetes therapy

Review

作者: Ziegler, Anette-Gabriele ; Kay, Thomas W H ; Cengiz, Eda

The treatment of type 1 diabetes is entering a transformative era. Teplizumab, the first immunotherapy treatment to delay the onset of clinical type 1 diabetes, has been approved by the US Food and Drug Administration. Other immune-based therapies show promise in preserving β-cell function. Public health screening using islet autoantibodies is expanding, enabling earlier diagnosis, reducing diabetic ketoacidosis, and allowing timely introduction of disease-modifying treatments before the need for insulin therapy. β-cell replacement is shifting from traditional transplantation of organ donor islets and the pancreas to stem cell-derived β cells. Bioengineering methods, such as encapsulation, and gene editing to create hypoimmune cells could reduce the need for immunosuppression that has hampered β-cell replacement, and patient-derived stem cells open doors to personalised therapies. Although these innovations have been made available to a small number of patients, scaling them to widespread use remains a challenge. Meanwhile, glucose regulation is improving through the use of automated insulin delivery systems that combine glucose monitoring with insulin pumps. New-generation insulins (those that are ultrarapid, ultralong, and glucose-responsive) improve outcomes by minimising blood sugar fluctuations. Together, these breakthroughs offer renewed hope for improving long-term management and quality of life for people living with type 1 diabetes.

2025-09-01·EClinicalMedicine

Quality of antidiabetic medicines in 13 sub-Saharan African countries: a cross-sectional survey

Article

作者: Jouven, Xavier ; Mipinda, Jean Bruno ; Toure, Ibrahim Ali ; Empana, J P ; Perier, Marie Cécile ; Kake, Amadou ; Takombe, Jean Laurent ; Cavagna, Pauline ; Diop, I Bara ; Boitard, Christian ; Secretan, Philippe Henri ; Do, Bernard ; Balde, Naby Moussa ; Mbaye, Maimouna Ndour ; Antignac, Marie ; Sy, Ely Cheikh Ibrahima ; Lubenga, Yves ; Dalaba, Maxwell ; N'Guetta, Roland ; Isselmou Boukhary Ould, El Bou ; Sobngwi, Eugène ; Cisse, Pr Badara ; Dia, Mouhamadoul Mounir ; Ikama, Meo Stephane

Background:

The burden of diabetes is rising dramatically in low- and middle-income countries. The menace of substandard and falsified drugs constitutes a major hazard that compromises healthcare. The DIABDAF study aimed to assess the quality of routinely used antidiabetic drugs including oral drugs and insulins in sub-Saharan Africa.

Methods:

Drugs were collected in 13 sub-Saharan African cities in licensed and unlicensed places of sales between February 2020 and March 2023. Chemical analyses were conducted blindly in a public laboratory following recommended good laboratory practices. Drug quality was classified based on the ratio of measured to expected active ingredient dosage: 95-105% as good (A), 85-94·99% or 105·01-115% as low (B), and below 85% or above 115% as very low (C). Impurity levels were assessed using thresholds from the United States and European Pharmacopoeias monographs.

Findings:

A convenient samples of 4951 antidiabetic drugs were collected from 13 sub-Saharan African countries (Seven middle-income and six low-income countries). Out of the 1673 (of 4951 collected) drug samples randomly tested, 28·0% (n: 468, 95% CI [22·3-33·0]) failed to meet standards related to the expected content of active ingredients (B: 27·2% 95% CI [21·5-32·0]; C: 0·8% 95% CI [0·2-3·5]), with more samples showing underdosage (19·31% 95% CI [14·8-24·3]) than overdosage (8·67% 95% CI [5·3-12·5]). Impurity levels were excessive in 9·68% (n: 162, 95% CI [6·0-14·8]) of samples. Overall, 32·8% (n: 548, 95% CI [26·5-38·1]) were deemed to be of poor quality according to active ingredient content or impurity level. In multivariate logistic regression, factors associated with worse quality were drugs, expired status, and country of purchase.

Interpretation:

In this multinational study assessing the quality of antidiabetic drugs in sub-Saharan Africa, we found a significant proportion of poor-quality drugs. National health authorities must take action to ensure access to safe, high-quality medications for diabetic patients.

Funding:

DIABDAF study was exclusively supported by French public grant (INSERM, AVIESAN, AP-HP, and University of Paris Cité).

项与 Insulins(Halozyme) 相关的新闻（医药）

2025-10-16

·PRNewswire

Biocon Biologics and Civica Expand Partnership and Launch Private-Label Insulin Glargine to Broaden U.S. Diabetes Treatment Options

Additional treatment options for the 38.4 million U.S. patients living with diabetes BRIDGEWATER, N.J. and BENGALURU, India, Oct. 16, 2025 /PRNewswire/ -- Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), today announced expansion of its strategic collaboration with Civica, Inc. (Civica) to include a new Insulin Glargine medicine that will benefit patients in the United States by increasing supply of high-quality affordable insulins. The multi-year transformational agreement between Biocon Biologics and Civica creates an exclusive distributorship arrangement where Biocon Biologics will manufacture and supply Insulin Glargine medicine to Civica, and Civica will commercialize under Biocon Biologics' existing marketing approval (a private label agreement). Civica will distribute, promote, and sell the medicine in the United States under a separate Civica label and trade dress, and in California, the product will carry the CalRx brand. Biocon Biologics will continue to directly commercialize Biocon Biologics' own Insulin Glargine-yfgn medicine, which was approved by the U.S. Food and Drug Administration (FDA) in July 2021 as the first interchangeable biosimilar. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd, said : " Biocon Biologics is committed to expanding access to affordable, high-quality insulins in the U.S. and globally. By extending our collaboration with Civica, Inc. to include Insulin Glargine, we are building on our differentiated approach to serving and enhancing patient access—by retaining our direct commercialization and through this strategic partnership. This collaboration enables us to reach underserved populations through new channels in direct alignment with our mission. " No technology transfer is involved in the agreement and Biocon Biologics will continue to own the intellectual property and marketing authorization associated with Insulin Glargine. Additional terms of the agreement are not disclosed. This agreement expands the relationship between the two organizations that previously announced that Biocon Biologics will provide Civica with Insulin Aspart drug substance to manufacture in the United States. Ned McCoy, President and Chief Executive Officer, Civica, Inc., said: "We are pleased to expand our partnership with Biocon Biologics, which helps us achieve a significant milestone in our insulin initiative. Today's announcement allows us to realize our goal of bringing insulin to people who need it at a transparent low price." Insulin glargine-yfgn injection is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of use: Insulin glargine-yfgn is not recommended for the treatment of diabetic ketoacidosis. There are 38.4 million people with diabetes in the United States, approximately 11.6 percent of the total population, with nearly a quarter being undiagnosed. An additional 97.6 million Americans have been identified as prediabetic.1 Biocon Biologics is a global leader in biosimilars and insulin production and is the fourth largest insulins company in the world, providing over 9.2 billion doses of insulin globally with a broad portfolio comprising basal, mixed and rapid acting insulins. Important Safety Information: Insulin Glargine-yfgn is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin glargine products or any of the excipients in Insulin Glargine-yfgn. Warnings and Precautions: Insulin pens, needles, or syringes must never be shared between patients. Do NOT reuse needles. Monitor blood glucose in all patients treated with insulin. Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Make any changes to a patient's insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia. Advise patients to rotate the injection site to unaffected areas and closely monitor for hypoglycemia. Hypoglycemia is the most common adverse reaction associated with insulins, including insulin glargine products. Severe hypoglycemia can cause seizures, may be life threatening, or cause death. Hypoglycemia can impair concentration and reaction time. Accidental mix-ups between insulin products have been reported. To avoid medication errors between Insulin Glargine-yfgn and other insulins, instruct patients to always check the insulin label before each injection. Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Insulin Glargine-yfgn, treat and monitor until symptoms and signs resolve. All insulin products, including Insulin Glargine-yfgn, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia, if indicated. Fluid retention, which may lead to or exacerbate heart failure can occur with concomitant use of thiazolidinediones (TZDs) with insulin. These patients should be observed for signs and symptoms of heart failure. If heart failure develops, dosage reduction or discontinuation of the TZD must be considered. Do not dilute or mix Insulin Glargine-yfgn with any other insulin or solution. If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner. Do not administer Insulin Glargine-yfgn via an insulin pump or intravenously because hypoglycemia can occur. A reduction in the Insulin Glargine-yfgn dose may be required in patients with renal or hepatic impairment. Refer to full Prescribing Information for insulin glargine-yfgn injection for more information. 1 U.S. Department of Health & Human Services, Centers for Disease Control and Prevention. "National Diabetes Statistics Report." Accessed: January 28, 2025. Last Reviewed: May 15, 2024. About Biocon Biologics Limited: Biocon Biologics Limited, a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its 'lab to market' capabilities to serve over 6.0 million patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. Biocon Biologics has commercialized 10 biosimilars from its portfolio which are addressing the patients' needs in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, ophthalmology, bone health and other non-communicable diseases. The Company has many 'firsts' to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). The meaningful progress on ESG parameters has been recognized with the Company's inclusion in the S&P Global Sustainability Yearbook in 2025. Website: ; Follow us on X (formerly Twitter): @BioconBiologics and LinkedIn: Biocon Biologics for company updates. Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: ; Follow-us on X (formerly Twitter) @bioconlimited and LinkedIn: Biocon for company updates. About Civica, Inc.: Civica is a non-profit generic pharmaceutical company established in 2018 to address drug shortages. It was founded by a group of U.S. health systems and philanthropies who, after more than a decade of chronic shortages, recognized that the market was not self-correcting and that a different approach is required. Civica works to deliver a safe, stable, and affordable supply of essential medicines to U.S. patients. Civica has built a sterile injectable manufacturing plant in Petersburg, Virginia capable of producing prefilled pens and vials of insulin. Website: Follow us on X (formerly Twitter) @civicarx and LinkedIn: CivicaRx for company updates. Forward-Looking Statements: Biocon This press release may include statements of future expectations and other forward-looking statements based on management's current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release. BIOCON BIOLOGICS and the Biocon Biologics Logo are registered trademarks of Biocon Biologics Limited. CIVICA and the CIVICA Logo are registered trademarks of Civica, Inc. All other trademarks are the property of their respective owners. SOURCE Biocon Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准引进/卖出

2025-07-22

·国际糖尿病idiabetes

1+1＞2！GLP-1RA联合基础胰岛素，为T2DM患者提供更优治疗选择

点击“蓝字”关注我们编者按随着2型糖尿病（T2DM）治疗策略的不断演进，早期联合治疗已经成为临床管理的重要趋势[1]。GLP-1受体激动剂（GLP-1RA）与基础胰岛素的联合使用，凭借其显著的血糖控制、体重管理以及其他获益，已被证明为一种高效且安全的治疗选择[2]。近期，荟萃分析[3]和真实世界数据[4-5]进一步支持了这一方案的优势，特别是在优化基础胰岛素的选择上，二代基础胰岛素显示出更优的疗效。我们特邀广州医科大学附属第一医院陈小燕教授分享相关研究成果，探讨这一治疗策略最新进展，为临床实践提供宝贵的循证依据。1+1＞2！GLP-1RA联合基础胰岛素为T2DM患者提供更有效选择随着临床研究的持续深入，GLP-1RA与基础胰岛素的联合治疗已逐渐成为T2DM管理中的重要治疗策略。最近，Clinical Nutrition ESPEN发表的一项系统评价与荟萃分析[3]，深入探讨了司美格鲁肽联合基础胰岛素治疗T2DM患者的疗效与安全性。该研究进一步证实，GLP-1RA与基础胰岛素的联合应用能够实现“1+1＞2”的显著疗效，展现出综合治疗的优势，为T2DM患者提供了更为有效的治疗选择。这项荟萃分析共纳入了7项随机对照试验（RCT），共2354名患者。其中司美格鲁肽组1248例，对照组1106例。所有研究均采用平行组设计，其中1项为开放标签试验。样本量范围为60~1578例，干预持续时间为3~12个月。结果显示，与安慰剂或其他治疗方法相比，司美格鲁肽与基础胰岛素联合使用可显著降低糖化血红蛋白（HbA1c）[均值差（MD）：-1.17%，P<0.00001]、体重（MD -5.99 kg，P<0.00001）和空腹血糖（FPG）（MD -1.08%，P<0.00001）。此外，联合治疗还可优化血脂代谢[包括显著降低总胆固醇（TC）、甘油三酯（TG）、低密度脂蛋白（LDL），以及显著增加高密度脂蛋白（HDL）]、减少胰岛素用量。与此同时，不增加低血糖的发生风险（RR 1.36，P=0.26）。综上，该荟萃分析表明，GLP-1RA与基础胰岛素的联合治疗在血糖控制和体重减轻方面表现出显著改善，且未增加低血糖的风险。研究结果支持在T2DM患者中使用司美格鲁肽与基础胰岛素的联合治疗。择“优”联用！二代基础胰岛素是GLP-1RA控糖不佳时的更优选择在越来越多的循证证据支持下，《胰高糖素样肽-1受体激动剂联合胰岛素治疗2型糖尿病专家共识（2025版）》[6]指出，对于口服降糖药治疗血糖控制不佳的T2DM患者可起始基础胰岛素和GLP-1RA联合治疗；同时当患者通过改变生活方式、口服降糖药和 GLP-1RA无法使血糖控制达标时，需要开始使用胰岛素，这是病情发展所需。2025版《ADA糖尿病诊疗标准》[2]同样指出，当采用GLP-1RA治疗无法达到血糖目标时，需及时添加基础胰岛素治疗。真实世界研究RESTORE-G[4-5]显示，与一代基础胰岛素相比，二代基础胰岛素联合GLP-1RA治疗效果更优。RESTORE-G研究是一项真实世界、干预性、回顾性、队列研究，纳入2011至2021年期间接受GLP-1RA±口服降糖药物治疗的T2DM患者，患者改变治疗方案，起始一代基础胰岛素或二代基础胰岛素治疗，研究设计和分组情况见下图。图. RESTORE-G研究的设计情况图. RESTORE-G研究的分组情况结果显示：GLP-1RA控制不佳后，无论是联合还是转换治疗，与一代基础胰岛素相比，二代基础胰岛素均可实现更好的血糖控制。在联合治疗中，与一代基础胰岛素相比，二代基础胰岛素均可进一步降低HbA1c（估计均值差：-0.32%，P=0.04）和FPG（-1.15 mmol/L，P=0.007）。图. GLP-1 RA控制不佳的患者，联合二代基础胰岛素可实现更好的血糖控制在转换治疗中，与一代基础胰岛素相比，二代基础胰岛素同样可进一步降低HbA1c（估计均值差：-0.22%，P=0.03）和FPG（-0.56 mmol/L，P=0.03），并且体重增加更少（-0.67 kg，P=0.04）。图. GLP-1 RA控制不佳的患者，转为二代基础胰岛素可实现更好的血糖控制与固定比例组合德谷利拉相比，GLP-1RA自由联合甘精胰岛素U300对于FPG改善更显著（-1.4 mmol/L，P=0.0003），而HbA1c改善与体重变化相似。这与自由联合方案更加灵活，不同成分滴定更充分有关。图. 与固定比例组合德谷利拉相比，GLP-1RA自由联合甘精胰岛素U300治疗，FPG改善更显著综上，该真实世界研究表明，对于GLP-1RA治疗控制不佳的T2DM患者，联合或转换基础胰岛素，尤其是二代基础胰岛素是有价值的选择。总结GLP-1RA联合基础胰岛素已被证明是一种有效的T2DM治疗方案，能够显著改善血糖控制、体重管理和血脂水平，且不增加低血糖的风险。最新的系统评价与荟萃分析显示，司美格鲁肽与基础胰岛素联合使用在多个疗效指标上优于单独使用其他治疗方案。在基础胰岛素的选择上，二代基础胰岛素具有显著优势。真实世界RESTORE-G研究表明，与一代基础胰岛素相比，联合或转换二代基础胰岛素能更有效降低HbA1c和FPG。这些研究结果表明，GLP-1RA与基础胰岛素的联合治疗，尤其是与二代基础胰岛素联用，为T2DM患者提供了更为优效的治疗方案。专家简介陈小燕教授广州医科大学附属第一医院三级主任医师、医学博士、硕士生导师、博士后合作导师广州医科大学附属第一医院内分泌科科主任南山学院内分泌模块教研室负责人第三届“羊城好医生”、“岭南名医”广州市医学会内分泌分会副主委广东省保健协会糖尿病分会主委中国民族卫生协会糖尿病分会常委广东省营养学会公共营养专委会副主委广东省保健协会甲状腺保健分会副主委广东省健康管理学会代谢与内分泌分会副主委广东省精准医学应用学会更年期健康分会副主委广东省医学会内分泌分会常委广东省药理学会内分泌代谢药理专委会副主委中国老年医学学会骨质疏松分会妇产科学专委会委员参考文献：（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]American Diabetes Association Professional Practice Committee. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2025. Diabetes Care. 2025 Jan 1;48(1 Suppl 1):S181-S206. doi: 10.2337/dc25-S009. PMID: 39651989; PMCID: PMC11635045.[3]Chen B, Tao L, Tian M, et al. Efficacy and safety of combination of semaglutide and basal insulin in patients with of type 2 diabetes mellitus: A systematic review and meta-analysis. Clin Nutr ESPEN. 2025 Apr;66:564-572. doi: 10.1016/j.clnesp.2025.01.056. Epub 2025 Jan 30. PMID: 39892787.[4]Napoli R, Nicolucci A, Larosa M, et al. Treatment intensification following glucagon-like peptide-1 receptor agonists in type 2 diabetes: Comparative effectiveness analyses between different basal insulins. RESTORE-G real-world study. Diabetes Obes Metab. 2024 Sep;26(9):3576-3586. doi: 10.1111/dom.15697. Epub 2024 Jun 10. PMID: 38853712.[5]Candido R, Nicolucci A, Larosa M, et al. Treatment intensification following glucagon-like peptide-1 receptor agonist in type 2 diabetes: Comparative effectiveness analyses between free vs. fixed combination of GLP-1 RA and basal insulin. RESTORE-G real-world study. Nutr Metab Cardiovasc Dis. 2024 Aug;34(8):1846-1853. doi: 10.1016/j.numecd.2024.03.023. Epub 2024 Mar 23. PMID: 38693036.[6]中国研究型医院学会糖尿病学专业委员会.胰高糖素样肽-1受体激动剂联合胰岛素治疗2型糖尿病专家共识(2025版)[J].中华糖尿病杂志, 2025, 17(04):421-430.DOI:10.3760/cma.j.cn115791-20241213-00729.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。4M号: MAT-CN-2512248 版本: 1.0 审批日期: 2025年7月最新《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。

临床结果临床2期

2025-06-05

·ETPharma

Inside India’s Biosimilar Challenge: Regulatory Hurdles, Rare Diseases, and the Road Ahead

By Vishal Kumar Singh Mumbai: India’s biosimilar ecosystem is expanding fast, but navigating the regulatory maze remains a major hurdle—especially for stakeholders trying to bring affordable innovation to market. At the panel discussion titled "Easing Biosimilar Trials: The Role of Regional Cooperation," under the second edition of ETPharma Clinical Research and Excellence Conference (CREC) moderated by Viraj Suvarna, Independent Healthcare Consultant, industry leaders explored how regulatory clarity, cross-border collaboration, and trust-building could unlock biosimilars ’ potential especially for chronic and rare diseases. The panel featured Dr. Khokan Debnath, Senior GM of Clinical Operations, Regulatory Affairs, and Pharmacovigilance Compliance , QA (India & ROW), Wockhardt Ltd and Dr. Dipanjana Datta, Genetic Counselor and State Coordinator for the Organization for Rare Diseases India, whose frontline experiences with rare disease challenges added a critical patient-centric lens. India’s updated biosimilar guidelines propose waivers for animal studies and, in select cases, Phase III clinical trials when robust structural and functional similarity is demonstrated. While this aligns with global trends toward reducing redundancy, panelists emphasized unresolved ambiguities. Aligning Policy with Practice: India’s Regulatory Landscape Opening the session, Dr. Viraj Suvarna invited Dr. Khokan Debnath to share his views on the revised biosimilar guidelines issued by the Central Drugs Standard Control Organization ( CDSCO ). Dr. Debnath noted the inclusion of modern scientific tools, like in vitro and orthogonal similarity studies, which now have the potential to replace in vivo trials. However, he flagged serious concerns about procedural clarity. “Suppose I give my dossier on day one—whether on day 30 they will say that your dossier is complete and you will get a waiver, or whether questions will keep coming—that remains unclear,” he said, pointing out the absence of timelines and predictability that could delay patient access. Beyond timelines, he called for regulatory nuance in differentiating simple and complex biosimilars. Drawing on examples like insulin, he noted that “we cannot really do an immunity study on insulins,” emphasizing the difficulty of applying generic trial protocols across diverse biologics . The call was not just for policy updates—but for better interpretation and implementation by industry and regulators alike. To improve efficiency, Dr. Debnath recommended a “deemed approval” system—where applications proceed automatically if left unanswered within a defined period—and a feedback mechanism with stage-wise guidance from DCGI. He concluded by bringing the focus back to the patient. “We need to come up with a solution which is compatible with patients , something they can use on a regular basis and not lose compliance,” he said. Gaps in the Draft: Clarity, Biomarkers, and Surveillance Dr. Deepanjana Datta added to the discourse by spotlighting two specific gaps in the current framework: insufficient guidance on trial waivers and inadequate provisions for post-approval surveillance. Dr. Datta echoed concerns around the ambiguity in defining residual uncertainty and selecting robust biomarkers—critical elements for determining whether a Phase III trial waiver is justified. She emphasized that while the guidelines reference these criteria, they fall short of offering clear direction on how such studies should be structured or evaluated. Her concern centered on the absence of definitions for core scientific parameters—making it difficult for manufacturers to align their studies with regulatory expectations. Dr. Datta also raised concerns about the lack of clarity in the draft guidelines regarding pharmacovigilance protocols and standards for establishing interchangeability with reference biologics. She pointed out that the framework does not sufficiently address how comparability with the original product should be demonstrated. Yet, she expressed hope that future iterations of the draft would bring more precision, helping shape a robust, transparent biosimilar ecosystem. Scientific Rigor vs Speed: Finding the Balance Dr. Viraj Suvarna acknowledged the intent behind regulatory updates while underscoring the need for scientific rigour. “The first step of that triangle, right at the bottom, is the biggest, which is the structural and functional characterization. If that you do well… then only the next steps come in,” he explained, reiterating the foundation of biosimilar evaluation. While he supported efforts to speed up approvals, he cautioned against bypassing clinical validation. “People want to do away with clinical trials so that you can come faster to market… but we’re dealing with a biologic. Even that biosimilar is a biologic,” he said. He also highlighted sourcing issues: “Are you purchasing that original reference biologic from the innovator, or are you purchasing it from elsewhere? That is also important.” Rare Diseases and Equity: Bridging Access Gaps The conversation then shifted to rare diseases, with Dr. Suvarna asking how biosimilars could make treatments more accessible in high-cost conditions like hemophilia and Pompe disease. Dr. Datta was candid. “The cost, whatever therapies we have, are huge,” she said. “Either the government is bleeding, or the family of the patients are bleeding.” She acknowledged R&D costs but pointed to existing biosimilars for molecules like rituximab that had made a real difference in patient access. Still, she flagged the ongoing reluctance among clinicians. “Are clinicians comfortable prescribing biosimilars? They are not,” she observed. She proposed involving patient advocacy groups to build trust and promote adoption. Interestingly, she saw biosimilars not as competition, but as catalysts for innovation. “If biosimilars come in, then it’s an innovation which will be disruptive… but will also pave more ways for innovation,” she said. Market Challenges: ROI, Logistics, and Awareness Dr. Debnath brought attention to the unique constraints of developing biosimilars for rare diseases. “For a pharma company, also making a biosimilar for rare disease is a challenge… they don't see a market,” he noted. Lack of government support and perceived low ROI often discourages investment in this area. To address this, he stressed global logistics and collaboration. “We have to make the pharma companies aware that there's a market available… biosimilars increase competition,” he said, asserting that competition from biosimilars forces innovators to lower prices—benefitting patients. Toward Regulatory Harmony: Cross-Border Approvals Dr. Suvarna proposed regional harmonization as a possible solution. “Can we have some kind of regulatory harmonization… so it’s much faster to market?” he asked. Dr. Debnath stated that, “I have very good examples where trials of insulins are being used in Malaysia or Philippines,” he said. He emphasized that robust safety systems are increasingly valued over replication of local trials. Trust and Data: Building Acceptance Among Patients and Clinicians Dr. Suvarna raised another crucial issue: adoption. Despite growing availability, only a small fraction of doctors prescribe biosimilars. “What about the inclusion of patient-reported outcomes and experiences?” he asked. Dr. Datta highlighted how advocacy groups could fill this trust gap. “If we have data on patient outcomes or experiences, that is a very positive point,” she said, adding that patient advocacy and support groups are often better positioned to track long-term data and report adverse events—roles clinicians may struggle to fulfill consistently. Dr. Debnath echoed the need to build both “confidence for the doctors and trust for the patients.” He emphasized the importance of post-marketing studies and continuous real-world data collection to demonstrate a sustained commitment to safety, efficacy, and patient well-being. Final Points: Identification, Interchangeability, and Education Dr. Suvarna closed with two technical aspects. he emphasized that every biologic and biosimilar has a four-letter unique suffix, which should be reported along with the brand name, so that it is clear whether an event is associated with a particular biosimilar, or another biosimilar. Second, he discussed interchangeability studies, citing FDA’s “three-switch” requirement. This, he explained, is essential to show that patients can switch between reference and biosimilar products safely. Panelists agreed that India’s biosimilar ecosystem holds immense promise—but realizing it will require regulatory clarity, patient trust, and industry-wide collaboration. With the right structures in place, biosimilars could truly democratize access to complex therapies—across price points, across geographies, and across generations. By Online Bureau ,

临床3期

100 项与 Insulins(Halozyme) 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
-	Insulins(Halozyme)	A10AB05	DB01306

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
1型糖尿病	临床2期	美国	Halozyme Therapeutics, Inc.	2010-08-01
2型糖尿病	临床2期	美国	Halozyme Therapeutics, Inc.	2009-07-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03662334 (HALO-117-406, CTgov)	临床4期	1型糖尿病	14	Sham injection	窪廠選鑰艱顧淵鬱膚壓(齋繭鏇製鑰壓遞鏇鏇願) = 遞鏇製遞夢製壓繭構築衊積憲範憲醖糧簾範膚 (鏇製願窪鬱鏇鏇憲鏇願, 鹽襯餘鹹衊夢獵範廠壓 ~ 壓鹽簾鬱淵顧醖憲齋觸) 更多	-	2019-02-01
NCT00883558 (CTgov)	临床2期	1型糖尿病	48	recombinant human insulin (INSULIN-PH20 NP)	襯鹹廠鏇遞淵糧淵繭鏇(範餘糧網簾製繭膚淵糧) = 觸壓壓衊廠餘鏇壓憲遞簾窪憲醖築獵簾遞餘鹽 (簾獵襯構憲廠蓋鑰簾遞, 36.040) 更多	-	2014-09-08
				Insulin Lispro (Insulin Lispro)	襯鹹廠鏇遞淵糧淵繭鏇(範餘糧網簾製繭膚淵糧) = 鹹選窪夢齋鬱顧夢艱衊簾窪憲醖築獵簾遞餘鹽 (簾獵襯構憲廠蓋鑰簾遞, 35.113) 更多
NCT00774800 (CTgov)	临床2期	1型糖尿病	22	rHuPH20+Humalog (Humalog + rHuPH20)	鹹構壓鑰繭壓積餘鏇鑰(獵構壓窪築觸鹹窪鬱遞) = 淵鹹顧願觸鏇醖繭選蓋糧鑰壓範艱獵顧衊壓獵 (獵糧艱蓋鑰網積淵艱積, 4996.79) 更多	-	2014-09-05
				Humalog (Humalog Alone)	鹹構壓鑰繭壓積餘鏇鑰(獵構壓窪築觸鹹窪鬱遞) = 窪餘選蓋鹹鹹顧積網窪糧鑰壓範艱獵顧衊壓獵 (獵糧艱蓋鑰網積淵艱積, 3670.03) 更多
NCT01194245 (CTgov)	临床2期	1型糖尿病	135	recombinant human hyaluronidase PH20+insulin aspart+insulin lispro (Analog-PH20)	製鏇觸製鬱觸壓遞顧壓(鏇餘壓衊觸願襯蓋願廠) = 襯蓋憲簾憲鹹廠鹹遞繭簾願淵齋糧鏇積餘鬱選 (醖築衊餘鹹窪憲淵壓糧, 0.415) 更多	-	2014-08-19
				Insulin Lispro (Insulin Lispro)	製鏇觸製鬱觸壓遞顧壓(鏇餘壓衊觸願襯蓋願廠) = 選選構窪構繭襯窪襯餘簾願淵齋糧鏇積餘鬱選 (醖築衊餘鹹窪憲淵壓糧, 0.440) 更多
NCT00916357 (CTgov)	临床2期	2型糖尿病	23	Humalog (Humalog Alone)	襯獵顧糧蓋淵憲糧醖構(繭顧網鬱淵淵廠觸鏇鹽) = 憲艱鬱蓋餘願壓襯窪鑰糧餘廠夢憲觸鏇網壓鹹 (窪鑰艱廠膚夢窪獵糧簾, 32.28) 更多	-	2014-08-18
				rHuPH20+Humalog (Humalog + rHuPH20)	襯獵顧糧蓋淵憲糧醖構(繭顧網鬱淵淵廠觸鏇鹽) = 網膚廠衊鹹願範齋觸繭糧餘廠夢憲觸鏇網壓鹹 (窪鑰艱廠膚夢窪獵糧簾, 28.08) 更多
NCT01275131 (CTgov)	临床1期	1型糖尿病	45	Insulin Aspart (Stage 1: Insulin Aspart Alone)	窪顧鏇廠襯醖鏇觸齋選(夢憲鹹築憲糧窪構築繭) = 獵膚夢壓齋膚淵選艱壓網艱窪顧壓觸築衊醖鬱 (築網顧鹽淵蓋衊獵網築, 6.37) 更多	-	2014-07-25
				Insulin Aspart-rHuPH20 (Stage 1: Insulin Aspart-rHuPH20)	窪顧鏇廠襯醖鏇觸齋選(夢憲鹹築憲糧窪構築繭) = 願蓋艱夢鹽積鏇簾選鑰網艱窪顧壓觸築衊醖鬱 (築網顧鹽淵蓋衊獵網築, 9.48) 更多
NCT00705536 (CTgov)	临床1期	糖尿病	26	Humalog (Stage 1: Humalog Alone)	觸構淵鏇廠鹽獵構廠構(醖構淵膚鬱構膚壓廠醖) = 顧膚選遞築艱憲鑰網廠襯糧壓窪網範觸願築蓋 (願鏇積積醖積鑰鏇鹽衊, 35.9) 更多	-	2014-07-14
				rHuPH20+Humalog (Stage 1: Humalog + rHuPH20)	觸構淵鏇廠鹽獵構廠構(醖構淵膚鬱構膚壓廠醖) = 製壓遞鹽夢獵淵鬱鬱構襯糧壓窪網範觸願築蓋 (願鏇積積醖積鑰鏇鹽衊, 7.99) 更多
NCT00979875 (CTgov)	临床1期	-	14	Glulisine (Glulisine Alone)	餘鑰餘夢夢餘鑰鹽範網(範範簾製鬱構鹹齋簾鬱) = 顧鏇觸鏇鑰齋網鬱鬱淵壓築繭繭糧糧艱艱繭網 (餘製壓遞鑰鏇遞餘壓遞, 4085.00) 更多	-	2014-07-14
				Glulisine+rHuPH20 (Glulisine + rHuPH20)	餘鑰餘夢夢餘鑰鹽範網(範範簾製鬱構鹹齋簾鬱) = 範鹹網壓築壓鑰夢鏇觸壓築繭繭糧糧艱艱繭網 (餘製壓遞鑰鏇遞餘壓遞, 6657.73) 更多
NCT00916357 (Pubmed \| Diabetes Technol Ther)	临床2期	2型糖尿病	21	Insulin Lispro with Hyaluronidase	積鹹窪網襯廠積鹹觸夢(簾鬱憲襯蓋糧鑰選鹹壓) = 蓋憲糧襯觸鏇壓衊願鹹積鏇糧鏇壓餘製膚窪構 (觸衊齋襯餘廠觸觸憲淵 ) 更多	积极	2012-03-01