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.
DelveInsight’s, “Insulin Glargine Biosimilar Insight” report provides comprehensive insights about 10+ companies and 10+ marketed and pipeline drugs in Insulin Glargine Biosimilars landscape. It covers the marketed and pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
- 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. Request @ Insulin Glargine Biosimilars Drugs
- In June 2020, Mylan and Biocon Ltd. 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.
How many key players are involved in Insulin Glargine Biosimilars development?
Mylan, Polus BioPharm, Biocon, Wockhardt, Boehringer Ingelheim, Eli Lilly and Company, LG Chem, Harvest Moon Pharmaceuticals, GEROPHARM, Merck, Paras Biopharmaceuticals, GC Pharma, and others are some of the key players that are involved in Insulin Glargine Biosimilars development.
Table of contents
1. Key Insights
2. Insulin Glargine Biosimilars: Snapshot
3. Executive Summary
4. Regulatory Outlook For Biosimilars
4.1. North America
4.3. Asia Pacific
4.3.4. South Korea
4.4. Rest Of The World
4.4.4. Saudi Arabia
*More Countries would be added in the final report
5. Insulin Glargine (Reference Product: Lantus)
6. Research and Development
7. Lantus Biosimilar: Emerging Opportunities
8. Insulin Glargine: Biosimilars Assessment
9. Insulin Glargine Biosimilars Profiles: By Company
126.96.36.199. Semglee: Mylan
9.1.2. Polus BioPharm
188.8.131.52. PDP808: Polus BioPharm
184.108.40.206. Glaricon: Biocon
220.127.116.11. Glaritus: Wockhardt
10. Insulin Glargine Biosimilars: Comparative Landscape: By Company
11. Insulin Glargine Biosimilars: Competitive Landscape
12. Market Drivers
13. Market Barriers
14. SWOT Analysis
17. DelveInsight Capabilities
19. About DelveInsight
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