Insulin Glargine: Overview
Insulin glargine, marketed under the names Lantus among others, is a long-acting insulin, used in the management of type I and type II diabetes. It is typically the recommended long acting insulin in the United Kingdom. It is used once a day as an injection just under the skin. Insulin glargine is produced by recombinant DNA technology using a non-pathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from endogenous human insulin by the replacement of an asparagine residue at position A21 of the A-chain with glycine and addition of two arginines to the C-terminus (positions B31 and 32) of the B-chain. The resulting protein is soluble at pH 4 and forms microprecipitates at physiological pH 7.4 allowing for the slow release of small amounts of insulin glargine, giving the drug a long duration of action and no pronounced peak concentration.
Insulin Glargine Biosimilars: Drugs Chapters
This segment of the Insulin Glargine report encloses its detailed analysis of various drugs in different stages of clinical development, including marketed, phase III, II, I and preclinical. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.
Insulin Glargine Biosimilars Marketed Drugs
- Semglee: Mylan/Biocon
Semglee contains insulin glargine. This is a modified insulin, very similar to human insulin. Semglee is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and above. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar.
- Abasaglar: Eli Lilly
Insulin glargine biosimilar (Abasaglar) is licensed for the treatment of diabetes mellitus in adults, young people and children over 2 years. Abasaglar is a basal insulin for once daily use and is bioequivalent to insulin glargine (Lantus). Basaglar is not approved for use by anyone younger than 6 years old, and should not be used to treat type 2 diabetes in a child of any age.
Further product details are provided in the report. Request here @ Insulin Glargine Therapies
Insulin Glargine Biosimilars Emerging Drugs
- Insulin RinGlar: Geropharm
Insulin RinGlar is being developed by Geropharm for the treatment of Type 1 diabetes mellitus. This is the fifth insulin in the company portfolio, which will complete the Geropharm line of human recombinant insulins and analogues. RinGlar will become the first insulin glargine, which will be produced in Russia on a full cycle basis – from substance to the finished dosage form.
Further product details are provided in the report.
Insulin Glargine: Therapeutic Assessment
This segment of the report provides insights about the different Insulin Glargine biosimilars segregated based on following parameters that define the scope of the report, such as:
- Major Players in Insulin Glargine
There are approx. 10+ key companies which are developing the therapies for Insulin Glargine.
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Report Highlights
- The companies and academics are working to assess challenges and seek opportunities that could influence Insulin Glargine R&D. The therapies under development are focused on novel approaches to treat/improve Insulin Glargine.
- In June 2020, Mylan and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Semglee (insulin glargine injection), in vial and pre-filled pen presentations, to control high blood sugar in adults with type 2 diabetes and adult and pediatric patients with type 1 diabetes. Semglee has an identical amino acid sequence to Sanofi’s Lantus and is approved for the same indications.
- In July 2019, there was an official signing ceremony for the partnership agreement between GEROPHARM and NatiVita (Belarus) that stipulates a transfer of the Russian insulin production technology to the Belarussian party. This partnership between the companies is a strategy and facilitates strengthening bilateral relationship between the Russian Federation and the Republic of Belarus. Implementation of the project will make it possible to adjust highly technological production of insulins in Belarus within a short-term period of time and provide the citizens with modern, effective and affordable drugs.
- In July 2019, GEROPHARM received marketing authorization for long-action insulin analog – glargine under RinGlar invented name. The drug in two dosage forms – 3 ml cartridges and pre-filled disposable insulin pens RinAstra II – will take part in the state procurement procedure in the autumn of 2019.
TABLE OF CONTENTS
1. Key Insights
2. Insulin Glargine Biosimilars: Snapshot
3. Executive Summary
3.1. Overview
3.2. The Basics of Biologics.
3.3. Biosimilars are not the Same as Generic Drugs
3.4. Economics of Biosimilars – the Promise of Lower Prices, but at What Cost?
3.5. What Patients Need to Know About Biosimilars
4. Regulatory Outlook For Biosimilars
4.1. North America
4.1.1. US
4.1.2. Canada
4.2. Europe
4.3. Asia Pacific
4.3.1. China
4.3.2. India
4.3.3. Japan
4.3.4. South Korea
4.3.5. Australia
4.4. Rest Of The World
4.4.1. Brazil
4.4.2. Mexico
4.4.3. Argentina
4.4.4. Saudi Arabia
*More Countries would be added in the final report
5. Insulin Glargine (Reference Product: Lantus)
5.1. Drug Profile
5.2. Product Overview
5.3. Regulatory Approvals and Launch
5.4. Indications
5.5. Mechanism of Action
5.6. Dosage and Administration
5.7. Dosage and Strengths
5.8. Dose Modification
5.9. Route of Synthesis
5.10. Pharmacology
5.11. Pharmacodynamics
5.12. Pharmacokinetics
5.13. Adverse Reactions
5.14. Product Snapshot
5.15. Development Milestones
6. Research and Development
6.1. Clinical Trials Information
6.2. Safety and Efficacy
7. Lantus Biosimilar: Emerging Opportunities
8. Insulin Glargine: Biosimilars Assessment
8.1. Assessment by Product Type
8.2. Assessment by Route of Administration
8.3. Assessment by Molecule type
8.4. Sales Assessment
9. Insulin Glargine Biosimilars Profiles: By Company
9.1.1. Mylan
9.1.1.1. Semglee: Mylan
9.1.1.1.1. Product Information
9.1.1.1.2. Research and Development
9.1.1.1.3. Other Development Activities
9.1.1.1.4. General Description Table
9.1.2. Polus BioPharm
9.1.2.1. PDP808: Polus BioPharm
9.1.2.1.1. Product Information
9.1.2.1.2. Research and Development
9.1.2.1.3. Other Development Activities
9.1.2.1.4. General Description Table
9.1.3. Biocon
9.1.3.1. Glaricon: Biocon
9.1.3.1.1. Product Information
9.1.3.1.2. Research and Development
9.1.3.1.3. Other Development Activities
9.1.3.1.4. General Description Table
9.1.4. Wockhardt
9.1.4.1. Glaritus: Wockhardt
9.1.4.1.1. Product Information
9.1.4.1.2. Research and Development
9.1.4.1.3. Other Development Activities
9.1.4.1.4. General Description Table
*More Companies and products would be added in the final report
10. Insulin Glargine Biosimilars: Comparative Landscape: By Company
11. Insulin Glargine Biosimilars: Competitive Landscape
11.1.1. Overview
11.1.2. Market Share Analysis
11.1.3. Competitive Scenario
11.1.3.1. Product Launches and approval
11.1.3.2. Partnerships, Collaborations and Agreements
11.1.3.3. Acquisitions
11.1.3.4. Expansions
11.1.3.5. Patent Expiration of Biologics
*More information would be added in the final report
12. Market Drivers
13. Market Barriers
14. SWOT Analysis
15. Appendix
15.1. Research Methodology
15.1.1. Coverage
15.1.2. Secondary Research
16. Bibliography
17. DelveInsight Capabilities
18. Disclaimer
19. About DelveInsight
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