Comparative Study of the Pharmacokinetics and Pharmacodynamics of Rinsulin® R, Solution for Injection, 100 IU/ml (GEROPHARM LLC) and Humulin® Regular, Solution for Injection, 100 IU/ml (Eli Lilly) in Euglycemic Hyperinsulinemic Clamp Method

Pharmacokinetics and pharmacodynamics of Rinsulin® R, injection solution, 100 IU / ml (GEROPHARM LLC, Russia) and Humulin® Regular, injection solution, 100 IU / ml (Lilly France ", France) using the euglycemic hyperinsulinemic clamp method.

开始日期2018-02-19

申办/合作机构

Geropharm LLC

NCT04501250 / CompletedN/A

A Double-blinded, Randomized, Comparative, Crossover Pharmacokinetics Study of Rinsulin® NPH, Suspension for Subcutaneous Administration, 100 IU/ml (GEROPHARM LLC, Russia) and Humulin® NPH, Suspension for Subcutaneous Administration, 100 IU/ml (Lilly France, France) Using Method of Euglycemic Hyperinsulinemic Clamp on Healthy Volunteers

Сomparative pharmacokinetic study of Rinsulin® NPH, suspension for subcutaneous administration, 100 IU/ml (GEROPHARM LLC, Russia) and Humulin® NPH, suspension for subcutaneous administration, 100 IU/ml (Lilly France, France) using the euglycemic hyperinsulinemic clamp.

开始日期2017-10-23

申办/合作机构

Geropharm LLC

NCT04498884 / CompletedN/A

Double-blinded, Randomized, Comparative, Crossover Study of the Pharmacokinetics of Rinsulin® Mix 30/70, Suspension for Subcutaneous Administration, 100 IU / ml (OJSC GEROPHARM-Bio, Russia) and Humulin® M3, Suspension for Subcutaneous Administration, 100 IU / ml (Lilly France, France) Using the Method of Euglycemic Hyperinsulinemic Clamp on Healthy Volunteers

Pharmacokinetics and pharmacodynamics study of 2 formulations of insulin mixtures Rinsulin® Mix 30/70, Suspension for Subcutaneous Administration, 100 IU / ml (OJSC GEROPHARM-Bio, Russia) versus Humulin® M3, Suspension for Subcutaneous Administration, 100 IU / ml (Lilly France, France).

开始日期2017-07-18

申办/合作机构

Geropharm LLC

100 项与人胰岛素生物类似药（Geropharm）相关的临床结果

登录后查看更多信息

100 项与人胰岛素生物类似药（Geropharm）相关的转化医学

登录后查看更多信息

100 项与人胰岛素生物类似药（Geropharm）相关的专利（医药）

登录后查看更多信息

项与人胰岛素生物类似药（Geropharm）相关的文献（医药）

2022-09-01·DIABETES OBESITY & METABOLISM2区 · 医学

Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar Insulin 70/30 with US‐licensed HUMULIN® 70/30 formulation in healthy subjects: Results from the RHINE‐3 (Recombinant Human INsulinEquivalence‐3) study

2区 · 医学

Article

作者: Athalye, Sandeep N. ; Loganathan, Subramanian ; Lakshmi, Gopu Chandrasekharan ; Murugesan, Sundara Moorthi Nainar ; Panda, Jayanti ; Plum‐Mörschel, Leona ; Singh, Gursharan ; Sharma, Nirant ; Klein, Oliver ; Marwah, Ashwani

Abstract:

Aim:

To establish the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of proposed biosimilar insulin 70/30 (Biocon's Insulin‐70/30) and HUMULIN® 70/30 (HUMULIN‐70/30; Eli Lilly and Company, IN).

Materials and Methods:

In this phase 1, automated euglycaemic glucose clamp study, 78 healthy subjects were randomized (1:1) to receive a single dose of 0.4 IU/kg of Biocon's Insulin‐70/30 and HUMULIN‐70/30. Plasma insulin concentrations and glucose infusion rates (GIRs) were assessed over 24 hours. Primary PK endpoints were area under the insulin concentration‐time curve from 0 to 24 hours ‐ AUCins.0−24h ‐ and maximum insulin concentration ‐ Cins.max. Primary PD endpoints were area under the GIR time curve from 0 to 24 hours ‐ AUCGIR.0−24h ‐ and maximum GIR ‐ GIRmax.

Results:

Equivalence was shown between Biocon's Insulin‐70/30 and HUMULIN‐70/30 for the primary PK/PD endpoints. The 90% confidence intervals of the treatment ratios were entirely within the acceptance range of 80.00%‐125.00%. The secondary PK/PD profiles were also comparable. There were no clinically relevant differences in the safety profiles of the two treatments and no serious adverse events were reported.

Conclusion:

PK/PD equivalence was demonstrated between Biocon's Insulin‐70/30 and HUMULIN‐70/30 in healthy subjects. Treatment with Biocon's Insulin‐70/30 and HUMULIN‐70/30 was well tolerated.

2020-11-09·Cochrane Database of Systematic Reviews

(Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus.

Review

作者: Jeitler, Klaus ; Siebenhofer, Andrea ; Horvath, Karl ; Berghold, Andrea ; Semlitsch, Thomas ; Engler, Jennifer

BACKGROUND:

Evidence that antihyperglycaemic therapy is beneficial for people with type 2 diabetes mellitus is conflicting. While the United Kingdom Prospective Diabetes Study (UKPDS) found tighter glycaemic control to be positive, other studies, such as the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, found the effects of an intensive therapy to lower blood glucose to near normal levels to be more harmful than beneficial. Study results also showed different effects for different antihyperglycaemic drugs, regardless of the achieved blood glucose levels. In consequence, firm conclusions on the effect of interventions on patient-relevant outcomes cannot be drawn from the effect of these interventions on blood glucose concentration alone. In theory, the use of newer insulin analogues may result in fewer macrovascular and microvascular events.

OBJECTIVES:

To compare the effects of long-term treatment with (ultra-)long-acting insulin analogues (insulin glargine U100 and U300, insulin detemir and insulin degludec) with NPH (neutral protamine Hagedorn) insulin (human isophane insulin) in adults with type 2 diabetes mellitus.

SEARCH METHODS:

For this Cochrane Review update, we searched CENTRAL, MEDLINE, Embase, ICTRP Search Portal and ClinicalTrials.gov. The date of the last search was 5 November 2019, except Embase which was last searched 26 January 2017. We applied no language restrictions.

SELECTION CRITERIA:

We included randomised controlled trials (RCTs) comparing the effects of treatment with (ultra-)long-acting insulin analogues to NPH in adults with type 2 diabetes mellitus.

DATA COLLECTION AND ANALYSIS:

Two review authors independently selected trials, assessed risk of bias, extracted data and evaluated the overall certainty of the evidence using GRADE. Trials were pooled using random-effects meta-analyses.

MAIN RESULTS:

We identified 24 RCTs. Of these, 16 trials compared insulin glargine to NPH insulin and eight trials compared insulin detemir to NPH insulin. In these trials, 3419 people with type 2 diabetes mellitus were randomised to insulin glargine and 1321 people to insulin detemir. The duration of the included trials ranged from 24 weeks to five years. For studies, comparing insulin glargine to NPH insulin, target values ranged from 4.0 mmol/L to 7.8 mmol/L (72 mg/dL to 140 mg/dL) for fasting blood glucose (FBG), from 4.4 mmol/L to 6.6 mmol/L (80 mg/dL to 120 mg/dL) for nocturnal blood glucose and less than 10 mmol/L (180 mg/dL) for postprandial blood glucose, when applicable. Blood glucose and glycosylated haemoglobin A1c (HbA1c) target values for studies comparing insulin detemir to NPH insulin ranged from 4.0 mmol/L to 7.0 mmol/L (72 mg/dL to 126 mg/dL) for FBG, less than 6.7 mmol/L (120 mg/dL) to less than 10 mmol/L (180 mg/dL) for postprandial blood glucose, 4.0 mmol/L to 7.0 mmol/L (72 mg/dL to 126 mg/dL) for nocturnal blood glucose and 5.8% to less than 6.4% HbA1c, when applicable. All trials had an unclear or high risk of bias for several risk of bias domains. Overall, insulin glargine and insulin detemir resulted in fewer participants experiencing hypoglycaemia when compared with NPH insulin. Changes in HbA1c were comparable for long-acting insulin analogues and NPH insulin. Insulin glargine compared to NPH insulin had a risk ratio (RR) for severe hypoglycaemia of 0.68 (95% confidence interval (CI) 0.46 to 1.01; P = 0.06; absolute risk reduction (ARR) -1.2%, 95% CI -2.0 to 0; 14 trials, 6164 participants; very low-certainty evidence). The RR for serious hypoglycaemia was 0.75 (95% CI 0.52 to 1.09; P = 0.13; ARR -0.7%, 95% CI -1.3 to 0.2; 10 trials, 4685 participants; low-certainty evidence). Treatment with insulin glargine reduced the incidence of confirmed hypoglycaemia and confirmed nocturnal hypoglycaemia. Treatment with insulin detemir compared to NPH insulin found an RR for severe hypoglycaemia of 0.45 (95% CI 0.17 to 1.20; P = 0.11; ARR -0.9%, 95% CI -1.4 to 0.4; 5 trials, 1804 participants; very low-certainty evidence). The Peto odds ratio for serious hypoglycaemia was 0.16, 95% CI 0.04 to 0.61; P = 0.007; ARR -0.9%, 95% CI -1.1 to -0.4; 5 trials, 1777 participants; low-certainty evidence). Treatment with detemir also reduced the incidence of confirmed hypoglycaemia and confirmed nocturnal hypoglycaemia. Information on patient-relevant outcomes such as death from any cause, diabetes-related complications, health-related quality of life and socioeconomic effects was insufficient or lacking in almost all included trials. For those outcomes for which some data were available, there were no meaningful differences between treatment with glargine or detemir and treatment with NPH. There was no clear difference between insulin-analogues and NPH insulin in terms of weight gain. The incidence of adverse events was comparable for people treated with glargine or detemir, and people treated with NPH. We found no trials comparing ultra-long-acting insulin glargine U300 or insulin degludec with NPH insulin.

AUTHORS' CONCLUSIONS:

While the effects on HbA1c were comparable, treatment with insulin glargine and insulin detemir resulted in fewer participants experiencing hypoglycaemia when compared with NPH insulin. Treatment with insulin detemir also reduced the incidence of serious hypoglycaemia. However, serious hypoglycaemic events were rare and the absolute risk reducing effect was low. Approximately one in 100 people treated with insulin detemir instead of NPH insulin benefited. In the studies, low blood glucose and HbA1c targets, corresponding to near normal or even non-diabetic blood glucose levels, were set. Therefore, results from the studies are only applicable to people in whom such low blood glucose concentrations are targeted. However, current guidelines recommend less-intensive blood glucose lowering for most people with type 2 diabetes in daily practice (e.g. people with cardiovascular diseases, a long history of type 2 diabetes, who are susceptible to hypoglycaemia or older people). Additionally, low-certainty evidence and trial designs that did not conform with current clinical practice meant it remains unclear if the same effects will be observed in daily clinical practice. Most trials did not report patient-relevant outcomes.

2019-06-01·BMJ global health2区 · 医学

Insulin prices, availability and affordability in 13 low-income and middle-income countries

2区 · 医学

ArticleOA

作者: Ewen, Margaret ; Laing, Richard ; Beran, David ; Joosse, Huibert-Jan

Introduction:

Globally, one in two people needing insulin lack access. High prices and poor availability are thought to be key contributors to poor insulin access. However, few studies have assessed the availability, price and affordability of different insulin types in low-income and middle-income countries in a systematic way.

Methods:

In 2016, 15 insulin price and availability surveys were undertaken (using an adaptation of the WHO/Health Action International medicine price and availability measurement methodology) in Brazil, China (Hubei and Shaanxi Provinces), Ethiopia, Ghana, India (Haryana and Madhya Pradesh States), Indonesia, Jordan, Kenya, Kyrgyzstan, Mali, Pakistan, Russia (Kazan Province) and Uganda. Data were collected in three sectors (public, private pharmacies and private hospitals/clinics) in three regions per survey. Insulin prices were standardised to 10 mL 100 IU/mL in US dollars ($). Data were also collected for four comparator medicines.

Results:

Mean availability was higher for human (55%–80%) versus analogue insulins (55%–63%), but only short-acting human insulin reached 80% availability (public sector). Median government procurement prices were $5 (human insulins) and $33 (long-acting analogues). In all three sectors, median patient prices were $9 for human insulins. Median patient prices for analogues varied between the public sector ($34) and the two private sectors ($44). Vials were cheaper than pens and cartridges. Biosimilars, when available, were mostly cheaper than originators. A low-income person had to work 4 and 7 days to buy 10 mL human and analogue insulin, respectively. For isophane human insulin, only three countries meet the WHO target of 80% availability of affordable essential medicines for non-communicable diseases in any sector.

Conclusion:

Improving insulin availability and affordability needs to be addressed through national and global actions, including prioritising the supply of more affordable human insulin, increasing competition through the use of lower priced quality-assured biosimilars, negotiating lower prices from manufacturers and improving distribution systems.

项与人胰岛素生物类似药（Geropharm）相关的新闻（医药）

2022-09-06

·PRNewswire

Global Recombinant Cell Culture Supplements Market to Reach $1.18 Billion by 2032 at a CAGR of 12.2%

DUBLIN, Sept. 6, 2022 /PRNewswire/ -- The "Global Recombinant Cell Culture Supplements Market: Focus on Pricing Analysis, Product, Application, Expression System, and Region - Analysis and Forecast, 2022-2032" report has been added to ResearchAndMarkets.com's offering. The global recombinant cell culture supplements market was estimated at $308.6 million in 2021 and is expected to reach $1,188.6 million by 2032, growing at a CAGR value of 12.24% during the forecast period 2022-2032. The growth in the global recombinant cell culture supplements market is expected to be driven by the rising demand for cell culture supplements, increasing investment in life sciences research and development, as well as growing advantages of recombinant supplements over traditional animal-derived supplements. Market Lifecycle Stage The global recombinant cell culture market is increasing at a rapid pace. The growing need for animal-free supplements in cell culture applications is aiding the growth of the recombinant cell culture supplements market. Recombinant cell culture supplements play a crucial role in enhancing cell viability, maintaining a healthy culture, and customizing the cell culture in accordance with the needs of the individual. Increasing demand for immunotherapy and stem cell and regenerative medicine research is one of the major opportunities in the recombinant cell culture supplements market. Several cell culture companies, and biopharmaceutical companies are working collaboratively on drug development and using recombinant cell culture supplements as a therapeutic means for applications in biological drugs. Furthermore, the market witnessed major mergers and acquisitions in the past four years. For instance, recently, in March 2022, Thermo Fisher Scientific Inc. acquired PeproTech, Inc., a company that specializes in the development and manufacturing of recombinant proteins, in a deal of $1.85 billion. Impact Many biopharmaceutical products are being developed by utilizing the cell culture technique. The study of cell physiology and biochemistry is made possible through laboratory cell culture, which also opens up research avenues that are challenging to pursue in vivo. Controlling variables such as the culture media, culture conditions, population density, and growth rate makes it simple to assess the effects of medications or other substances on cultured cells. Additionally, it allows analyzing the function of various genes and offers enormous potential in the field of genetics. It enables the assessment of harmful and carcinogenic chemicals on cells in the fields of oncology and virology and the comprehension of how different medications, viruses, and physical or chemical carcinogens interact. Furthermore, the recombinant cell culture has various applications, such as research on vaccines, stem cells, gene therapy, and genetic engineering, as well as the creation of protein therapies manufacturing of genetically edited proteins such as monoclonal antibodies, insulin, and hormones. Market Dynamics Market Drivers Increasing Demand for Recombinant Cell Culture Supplements Due to their Advantages Increased Funding and Investment in Research and Development for Biopharmaceutical Products in Life Sciences Sector Growing Number of Mergers and Acquisitions for Expanding Recombinant Cell Culture Supplements Portfolio Push from Regulatory Bodies to Utilize Animal-Free Media Supplements in Cell Culture Process Market Restraints Challenging Manufacturing Process of Recombinant Proteins Technical Complexities Associated with Recombinant Cell Culture Supplements Market Opportunities Increasing Need for Immunotherapies and Stem Cell and Regenerative Medicines Increasing Preference for Serum-Free Media Market Segmentation by Product Recombinant Albumin (rAlbumin) Recombinant Insulin (rInsulin) Recombinant Epidermal Growth Factor (rEGF) Recombinant Interleukin Growth Factor (rILGF) Recombinant Transferrin (rTransferrin) Recombinant Trypsin (rTrypsin) Recombinant Insulin-like Growth Factor (rIGF) Recombinant Stem Cell Factor (rSCF) Recombinant Aprotinin (rAprotinin) Recombinant Lysozyme (rLysozyme) Others by Application Stem Cell and Regenerative Medicine Bio-Production Academic and Research Application by Expression System Mammalian E. Coli Yeast Others by Region North America Europe Asia-Pacific Latin America Rest-of-the-World Demand - Drivers and Limitations Following are the demand drivers for the global recombinant cell culture supplements market: Increasing Demand for Recombinant Cell Culture Supplements Due to their Advantages Increased Funding and Investment in Research and Development for Biopharmaceutical Products in Life Sciences Sector Growing Number of Mergers and Acquisitions for Expanding Recombinant Cell Culture Supplements Portfolio Push from Regulatory Bodies to Utilize Animal-Free Media Supplements in Cell Culture Process The market is expected to face some limitations too due to the following challenges: Challenging Manufacturing Process of Recombinant Proteins Technical Complexities Associated with Recombinant Cell Culture Supplements Key Topics Covered: 1 Market Overview 2 Product, $ Mn, 2021-2032 3 Application, $Mn, 2021-2032 4 Expression System, $Mn, 2021-2032 5 Region, $Mn, 2021-2032 6 Competitive Landscape 7 Company Profiles Companies Mentioned Abcam plc. BBI Solutions Corning Incorporated FUJIFILM Irvine Scientific, Inc. Gemini Bioproducts, LLC HiMedia Laboratories InVitria Kingfisher Biotech, Inc. Lonza Group AG Merck KGaA Novus Biologicals, LLC R&D Systems, Inc. Sartorius AG Sino Biological Inc. STEMCELL Technologies Inc. Thermo Fisher Scientific Inc. For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1904 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

基因疗法抗体疫苗免疫疗法并购

100 项与人胰岛素生物类似药（Geropharm）相关的药物交易

登录后查看更多信息