Safety and efficacy of GP40061 compared with originator insulin glargine (Lantus
            <sup>®</sup>
            ): a randomized open-label clinical trial

Karonova, Tatiana; Мосикян, А. А.; Mayorov, Alexander Yur'evich; Макаренко, И. Е.; Zyangirova, S. T.; Afonkina, Olena A; Беликова, Татьяна Михайловна; Zalevskaya, Alsu Gafurovna; Khokhlov, A. L.; Drai, Roman V

doi:10.2217/cer-2019-0136

Cited by 6 publications

(6 citation statements)

References 5 publications

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“…In addition, the safety results of Yamada et al and our study in hypoglycemia and severe hypoglycemia are 0.99 (95% CI 0.96 to 1.03) versus 0.96 (95% CI 0.85 to 1.09) and 1.09 (95% CI 0.80 to 1.47) versus 1.06 (95% CI 0.85 to 1.31), respectively. This study includes newly RCTs [ 25 , 28 – 30 ], pooled more comprehensive evidence in both long−/short acting insulin biologics, reports consistent outcomes than the previous study. However, our study grouped the studies with corrections combined with hypoglycemic drugs, and the results of the study were found to be similar (change of HbA1C at weeks 26, the MD were 0.03; 95% CI − 0.02 to 0.07, p = 0.28).…”

Section: Discussionmentioning

confidence: 83%

Efficacy and immunogenicity of insulin biosimilar compared to their reference products: a systematic review and meta-analysis

Yang

Tang

et al. 2022

BMC Endocr Disord

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Background To ascertain the efficacy, safety, and immunogenicity from existing evidence via conducting a meta-analysis of randomized controlled trials between biosimilar and originator insulins. Methods The PubMed, Cochrane Library, EMBASE, and ClinicalTrails.gov were searched to identify head-to-head randomized controlled trials (RCTs) that directly compare the efficacy and safety of biosimilar insulin and its originator. Efficacy was assessed by change of HbA1C, fasting plasma glucose (laboratory or self-monitoring of blood glucose (SMBG)), and change all mean of 7 points- or 8 points- SMBG. Safety was assessed by change in proportion hypoglycemia and serious hypoglycemia. The occurrence of anti-insulin antibodies (AIAs) was also evaluated. Results Fourteen RCTs with 6188 patients from different countries were included. Data were pooled using a random-effects model and were expressed as the mean difference (MD), odds ratio (OR), and 95% confidence interval (CI). In efficacy, Insulin biosimilar products showed similar in change of HbA1C at weeks 26 and 52, the MD were 0.03 (95% CI − 0.02 to 0.07, p = 0.28), and 0.05 (95% CI − 0.05 to 0.15, p = 0.36), respectively. The proportion of HbA1C less than 7% at endpoint, the OR were 1.04 (95% CI 0.89 to 1.20, p = 0.64). The change of fasting plasma glucose (laboratory or SMBG) mmol/L in 24–52 weeks and change all mean of 7 points−/8 points- SMBG mmol/L in 24–52 weeks, the MD were 0.02 (95% CI − 0.20 to 0.24, p = 0.87) and − 0.34 (95% CI − 1.35 to 0.67, p = 0.51), respectively. In occurrence of hypoglycemia (≥ 1 events) and severe hypoglycemia, the OR were 0.96 (95% CI 0.85 to 1.09, p = 0.52) and 1.06 (95% CI 0.85 to 1.31, p = 0.62). The AIA was 1.02 (95% CI 0.90 to 1.16, p = 0.76). Analysis stratified by type of diabetes and duration of insulin. There was no significant difference between the biosimilar and their reference group in a different type of diabetes and different duration of insulin. Conclusions Insulin biosimilar showed comparable characteristics with the reference drug in terms of efficacy, safety, immunogenicity, through comprehensive and specific conventional meta-analysis.

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Section: Discussionmentioning

confidence: 83%

Efficacy and immunogenicity of insulin biosimilar compared to their reference products: a systematic review and meta-analysis

Yang

Tang

et al. 2022

BMC Endocr Disord

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“…The question remains whether or not such a study includes all relevant patient groups for a sufficient period of time. A recent study performed in Russia with a BioIns of insulin glargine showed no differences in the immune response (or glycemic control) (24). Also, an in vitro evaluation of the immunogenic properties of a BioIns of insulin lispro showed no differences to both U.S.-and EUapproved Humalog based on a side-by-side biological similarity assessment (25).…”

Section: Immunogenicitymentioning

confidence: 93%

“…Participants from INSTRIDE 1 who completed 52 weeks of reference insulin glargine treatment were randomized 1:1 to the reference sequence (n = 63; insulin glargine for 36 weeks) or to the treatment-switching sequence (n = 64; MYL-1501D [weeks 0-12], insulin glargine [weeks [12][13][14][15][16][17][18][19][20][21][22][23][24], MYL-1501D [weeks [24][25][26][27][28][29][30][31][32][33][34][35][36]). The primary efficacy endpoint used to show equivalence between the two treatment sequences was a change in HbA1c from baseline to week 36.…”

Section: Methodsmentioning

confidence: 99%

New Insulins, Biosimilars, and Insulin Therapy

Danne

Heinemann²,

Bolinder

2021

Diabetes Technology & Therapeutics

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“…Средняя концентрация АИА к концу исследования составила 4,32 ± 7,12 ИЕД/л в группе инсулина РинГлар ® и 5,33 ± 12,11 ИЕД/л без достоверной динамики по сравнению с исходными результатами. Снижение HbA1c в группе РинГлар ® составило -0,66%, в группе оригинального инсулина гларгина -0,77%, разница была недостоверной (р = 0,326) [29].…”

Section: Endocrinologyunclassified

Evolution of insulin therapy in the light of innovative technologies of the 21<sup>st</sup> century

Demidova,

Titova

2024

Medicinskij sovet

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The advent of insulin biosimilars has ushered in a new era in the treatment of diabetes mellitus, promising increased accessibility and affordability of this life-saving medication. This comprehensive review explores the evolving landscape of insulin biosimilars, focusing on their therapeutic equivalence, regulatory considerations, and clinical implications. Biosimilars are biological drugs produced using innovative technologies that replicate the structure and action of the reference drug in a very close way and are not inferior in effectiveness and other characteristics to the original, but are more affordable in pricing. Assessing their therapeutic equivalence requires a multifaceted approach including physicochemical and biological characterization, preclinical studies, and performance testing. The introduction of biosimilar drugs into clinical practice is gradually gaining importance for global health, especially in the treatment of oncological, autoimmune, endocrine diseases and, in particular, diabetes. The process of their registration and introduction into patient treatment practice has already been standardized in developed countries, international documents necessary for implementation have been issued, and convincing and clear confirmation of the positive results obtained during preclinical and clinical studies proving the bioequivalence and interchangeability of the biosimilar and the reference drug is required. The clinical implications of insulin biosimilars are of paramount importance, impacting patient outcomes, healthcare costs, and overall diabetes management. This review synthesizes existing evidence on the efficacy, safety, and immunogenicity of insulin biosimilars, providing insights into their potential role in diabetes therapy. Insulin biosimilars represent a promising avenue for expanding access to insulin therapy while addressing the economic burden of diabetes care. This review underscores the importance of continued research, robust regulatory oversight, and informed clinical decision-making to maximize the benefits of insulin biosimilars for patients and healthcare systems worldwide.

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Safety and efficacy of GP40061 compared with originator insulin glargine (Lantus ^® ): a randomized open-label clinical trial

Cited by 6 publications

References 5 publications

Efficacy and immunogenicity of insulin biosimilar compared to their reference products: a systematic review and meta-analysis

Efficacy and immunogenicity of insulin biosimilar compared to their reference products: a systematic review and meta-analysis

New Insulins, Biosimilars, and Insulin Therapy

Evolution of insulin therapy in the light of innovative technologies of the 21<sup>st</sup> century

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Safety and efficacy of GP40061 compared with originator insulin glargine (Lantus ® ): a randomized open-label clinical trial

Cited by 6 publications

References 5 publications

Efficacy and immunogenicity of insulin biosimilar compared to their reference products: a systematic review and meta-analysis

Efficacy and immunogenicity of insulin biosimilar compared to their reference products: a systematic review and meta-analysis

New Insulins, Biosimilars, and Insulin Therapy

Evolution of insulin therapy in the light of innovative technologies of the 21<sup>st</sup> century

Contact Info

Product

Resources

About

Safety and efficacy of GP40061 compared with originator insulin glargine (Lantus ^® ): a randomized open-label clinical trial