A Randomised, Double-blind, Three-period, Partially Replicated Crossover, Euglycaemic Glucose Clamp Study in Healthy Volunteers to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity of Biocon's Human Insulin R U-500 and Humulin® R U-500 (RHINE-4: Recombinant Human INsulin Equivalence-4)

Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated design, crossover trial in healthy subjects

开始日期2022-05-30

申办/合作机构

Biocon Ltd.

[+1]

CTRI/2010/091/000627 / Completed临床3期

A Randomized, Active Controlled, Parallel Group, Multicentre, Two-Phase, Open-Label Study Comparing the Safety and Immunogenicity of Insugen R and Insugen N with Actrapid and Insulatard in Patients with Type 1 Diabetes Mellitus

开始日期2010-10-08

申办/合作机构

Biocon SA

EUCTR2010-018354-12-DE / Not yet recruitingN/A

开始日期2010-07-19

申办/合作机构-

100 项与 Recombinant human insulin(Biocon Ltd.) 相关的临床结果

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100 项与 Recombinant human insulin(Biocon Ltd.) 相关的转化医学

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100 项与 Recombinant human insulin(Biocon Ltd.) 相关的专利（医药）

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项与 Recombinant human insulin(Biocon Ltd.) 相关的文献（医药）

2018-11-01·Journal of diabetes investigation3区 · 医学

Cross‐sectional survey of biosimilar insulin utilization in Asia: The Joint Asia Diabetes Evaluation Program

3区 · 医学

ArticleOA

作者: Tsang, Chiu Chi ; Fu, Amy W C ; Kesavadev, Jothydev ; Lau, Eric ; Sobrepena, Leorino ; Yu, Weinan ; Kwan, Christine ; So, Wing Yee ; Tran, Quang Khanh ; Gani, Linsey ; Ho, Yoon Kun ; Mirasol, Roberto ; Phatak, Sanjeev Ratnakar ; Jia, Weiping ; Sheu, Wayne ; Mukhopadhyay, Monojitketan ; Aravind, Sosale ; Janakiraman, Hari ; Luk, Andrea ; Ozaki, Risa ; Jha, Sujeet ; Nguyen, Thy Khue ; Chan, Juliana C N ; Kumar, Kanakatte Mylariah Prasanna

Abstract:

Aims/Introduction:

Biosimilar insulin can reduce treatment costs, although the extent of its use is largely unknown. We examined biosimilar insulin use and its associations with the quality of glycemic control using the Joint Asia Diabetes Evaluation register.

Materials and Methods:

We carried out a cross‐sectional analysis in 81,531 patients with type 1 and type 2 diabetes enrolled into the Joint Asia Diabetes Evaluation Program from 2007 to 2014. All insulin related terms are extracted from the Joint Asia Diabetes Evaluation portal, and compared clinical profiles between biosimilar and originator insulin users. Multivariate analysis was performed to assess the association of biosimilar insulin compared with originator insulin with dosage, glycated hemoglobin and hypoglycemia events.

Results:

Amongst 81,531 patients, 20.5% (n = 16,738) were insulin‐treated. In four countries with high use of biosimilar insulin, 4.7% (n = 719) of insulin users (n = 10,197) were treated with biosimilar insulin (India n = 507, 70.3%; the Philippines n = 90, 12.5%; China n = 62, 8.6%; Vietnam n = 60, 8.3%). Biosimilar insulin users were younger and had higher body mass index, glycated hemoglobin, insulin dosage and more frequent hypoglycemia than originator insulin users. These associations were non‐significant after adjustment for confounders. Only age, college education, diabetes education, lipid control, physical activity and history of cardiovascular complications were independently associated with these quality measures.

Conclusions:

Biosimilar insulin use is not uncommon in Asia. Data exclusion due to incomplete capturing of brand names suggests possibly higher use. The multiple determinants of the quality of glycemic control call for establishment of prospective cohorts and diabetes registers to monitor the safety and efficacy of different brands of biosimilar insulin and their impacts on clinical outcomes.

2001-01-01·Drug development and industrial pharmacy4区 · 医学

Effects of Low-Viscosity Sodium Hyaluronate Preparation on the Pulmonary Absorption of rh-Insulin in Rats

4区 · 医学

Article

作者: Masawo Kakemi ; Kazuhiro Morimoto ; Kunihiko Metsugi ; Kazunori Iwanaga ; Hideyuki Katsumata

PURPOSE:

A low-viscosity formulation for pulmonary delivery of rh-insulin as model peptide drugs was developed using a solution of sodium hyaluronate.

METHOD:

The effects of different concentrations and pH values of low-viscosity solutions of hyaluronate on the pulmonary absorption of rh-insulin were examined after intratracheal administration in rats. The permeation of fluorescein isothiocyanate (FITC)-dextran (molecular weight 4300; FD-4) and insulin through excised rat trachea in vitro were also examined.

RESULTS:

The hyaluronate (2140 kDa) solutions (0.1% and 0.2% w/v) at pH 7.0 significantly enhanced the pharmacological availability (PAB) of insulin compared to the aqueous solution of insulin at pH 7.0. The absorption-enhancing effect at a concentration of 0.1% w/v hyaluronate was greater than that at a concentration of 0.2% w/v hyaluronate. Furthermore, the greatest absorption-enhancing effect was obtained, regardless of the molecular weight of hyaluronate, when the concentration of hyaluronate was adjusted to 0.47 microM. Absorption-enhancing effects were consistent with the effect of a 0.1 w/v hyaluronate preparation at pH 4.0 and 7.0 on the permeation of FITC-dextran and insulin through excised rat trachea in vitro.

CONCLUSION:

Low-viscosity hyaluronate preparation was shown to be a useful vehicle for pulmonary delivery of peptide drugs.

项与 Recombinant human insulin(Biocon Ltd.) 相关的新闻（医药）

2022-09-02

·Endpoints

While Biocon continues to be one of the major players in the generics and biosimilars markets, several of the company’s manufacturing sites have ended up on the FDA’s radar. In a letter submitted to the stock exchange of India, Biocon stated that the FDA inspected three manufacturing facilities in the city of Bengaluru, India, and Johor, Malaysia. According to the letter, the inspections started with the Bengaluru site on Aug. 11 and concluded in Malaysia on Aug. 31. Biocon’s letter said that the inspections were due to three preapproval inspections for several biosimilars including bevacizumab, which is used to treat several forms of cancer, along with rh-insulin and insulin aspart, and a capacity expansion inspection for trastuzumab, another cancer treatment. Biocon said that the Form 483s had noted 11 observations each for the sites in Bengaluru along with six observations in Malaysia. The company said that the FDA’s observations are mainly related to improving microbial control, enhancing quality oversight, using more software and computer tools, facility upgrades and needing to implement other risk assessment tools. The company plans to submit an action plan to the FDA in the correct time frame. “We do not expect the outcome of these inspections to impact the current supply of our products,” a company spokesperson said in a statement . This is not the first time Biocon, and the FDA have crossed paths. Last year a Form 483 showed several issues that included an unqualified distribution system, inadequate aseptic monitoring and leaky drains, among other issues at one of its subsidiaries in Malaysia. In April, Biocon netted an insulin supply deal with the government of Malaysia, with the contract being valued at $90 million. The 483 also comes as Biocon shelled out $3.3 billion earlier this year to buy out Viatris’ biosimilars business, giving the company a new revenue stream in the process. However, Biocon is not alone in receiving scrutiny from the FDA. This year several major Indian manufacturers such as Aurobindo , Sun Pharma , Cipla and Cadila have all been hit with 483s for various infractions at manufacturing sites in the subcontinent.

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