Lantus (Insulin Glargine) Biosimilar Clinical Trial & Opportunity Insight

Publish Date:- Oct-2016       No Of Pages (35)

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“Lantus (Insulin Glargine) Biosimilar Clinical Trial & Opportunity Insight” report by PNS Pharma gives comprehensive clinical insight on 37 biosimilar version of Lantus drug in clinical pipeline.  Currently 5 biosimilar version of Lantus are commercially available in India, Japan, Kenya, Czech Republic, Estonia, Germany, China, Slovakia, United Kingdom for the treatment of Type 1 & 2 diabetes mellitus. The patent on Lantus expired in 2014.

Lantus is the brand name for Insulin Glargine, a man made form of hormone generally produced in the human body, used in the treatment of diabetes mellitus in children and adults. The long lasting process of insulin works to lower down the levels of glucose (sugar) in blood. Lantus is also used to treat type 2 & type 1 diabetes in adults and children having more than 6 years of age. The drug usually starts working after several hours of injection and keeps performing for 18-26 hours or more without any pronounced peak.

Lantus is a package consisting of a sterile solution of insulin glargine containing zinc, m-cresol, glycerol 85%, polysorbate and water for injection as inactive ingredients. Each milliliter of Lantus contains 100 Units (3.6378mg) of insulin glargine. The pH of Lantus is adjusted by addition of hydrochloric acid and sodium hydroxide. It has a pH value of approximately 4 making it completely soluble. It is produced by recombinant DNA technology using a non-pathogenic laboratory strain of Escherichia coli (K12) acting as production organism. Chemical representation of insulin glargine present in Lantus is 21A-Gly-30Ba-L-Arg-3030b-L-Arg-human insulin and empirical formula as C267H404N72O78S6 and a molecular weight of 6063.

The key function of Lantus consisting insulin is to regulate blood sugar levels is performed by stimulating peripheral glucose uptake by skeletal muscle and fat and by inhibiting hepatic glucose production. Lantus consists of a substitution of glycine as asparagine at N21 combining with 2 additional arginines to the carboxy terminal of B chain. The arginine amino acids are responsible for shifting the isoelectric point to 5.4 to 6.7, making the molecule more soluble in acidic pH and less soluble in physiological pH. This shift allows a subcutaneous injection of a clear solution.

Lantus treatment demands for daily dosage as injection under the skin into the subcutaneous tissue and not intravenously or by using insulin pumps. The injection is to be taken once in day time followed by 1 injection each day at the same time. The dosage is adjusted according to individual’s physical activity, severe conditions of illness and changes in food intake. It is injected into abdominal area, thigh and deltoid. The place to inject can be replaced within the region to reduce the risk of side effects.

Common side effects of Lantus include anxiety, blurred vision, chills, cold sweats, coma, dizziness, pale skin, drowsiness, excessive hunger, fast heartbeat, headache, nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, unusual tiredness and behavior similar to being drunk. The list of rare side effects includes fast pulse, skin rash or itching on whole body, sweating and trouble breathing. Other minor side effects are fever, sore throat, stuffy or runny nose and rashes, thickening, itching or pain at injection site.


“Lantus (Insulin Glargine) Biosimilar Clinical Trial & Opportunity Insight” report by PNS Pharma gives comprehensive clinical insight on 37 biosimilar version of Lantus drug in clinical pipeline.  Currently 5 biosimilar version of Lantus are commercially available in India, Japan, Kenya, Czech Republic, Estonia, Germany, China, Slovakia, United Kingdom for the treatment of Type 1 & 2 diabetes mellitus. The patent on Lantus expired in 2014.

Lantus is the brand name for Insulin Glargine, a man made form of hormone generally produced in the human body, used in the treatment of diabetes mellitus in children and adults. The long lasting process of insulin works to lower down the levels of glucose (sugar) in blood. Lantus is also used to treat type 2 & type 1 diabetes in adults and children having more than 6 years of age. The drug usually starts working after several hours of injection and keeps performing for 18-26 hours or more without any pronounced peak.

Lantus is a package consisting of a sterile solution of insulin glargine containing zinc, m-cresol, glycerol 85%, polysorbate and water for injection as inactive ingredients. Each milliliter of Lantus contains 100 Units (3.6378mg) of insulin glargine. The pH of Lantus is adjusted by addition of hydrochloric acid and sodium hydroxide. It has a pH value of approximately 4 making it completely soluble. It is produced by recombinant DNA technology using a non-pathogenic laboratory strain of Escherichia coli (K12) acting as production organism. Chemical representation of insulin glargine present in Lantus is 21A-Gly-30Ba-L-Arg-3030b-L-Arg-human insulin and empirical formula as C267H404N72O78S6 and a molecular weight of 6063.

The key function of Lantus consisting insulin is to regulate blood sugar levels is performed by stimulating peripheral glucose uptake by skeletal muscle and fat and by inhibiting hepatic glucose production. Lantus consists of a substitution of glycine as asparagine at N21 combining with 2 additional arginines to the carboxy terminal of B chain. The arginine amino acids are responsible for shifting the isoelectric point to 5.4 to 6.7, making the molecule more soluble in acidic pH and less soluble in physiological pH. This shift allows a subcutaneous injection of a clear solution.

Lantus treatment demands for daily dosage as injection under the skin into the subcutaneous tissue and not intravenously or by using insulin pumps. The injection is to be taken once in day time followed by 1 injection each day at the same time. The dosage is adjusted according to individual’s physical activity, severe conditions of illness and changes in food intake. It is injected into abdominal area, thigh and deltoid. The place to inject can be replaced within the region to reduce the risk of side effects.

Common side effects of Lantus include anxiety, blurred vision, chills, cold sweats, coma, dizziness, pale skin, drowsiness, excessive hunger, fast heartbeat, headache, nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, unusual tiredness and behavior similar to being drunk. The list of rare side effects includes fast pulse, skin rash or itching on whole body, sweating and trouble breathing. Other minor side effects are fever, sore throat, stuffy or runny nose and rashes, thickening, itching or pain at injection site.

1. Lantus (Insulin glargine) Clinical Insight

  1.1 Clinical Introduction

  1.2 Patent Analysis by Indication

  1.3 Phase of Development

  1.4 Brand Names by Country/Region

 

Lantus Biosimilars Clinical Insight by Company

 

2. Insulin Glargine (Insulin U300)

  2.1 Clinical Insight

  2.2 Development Timeline

  2.3 Patent Analysis

  2.4 Phase of Development

 

3. Insulin Glargine - HEC Pharm

  3.1 Clinical Insight

  3.2 Phase of Development

 

4. Insulin Glargine Biosimilar - Biocon/Mylan

  4.1 Clinical Insight

  4.2 Development Timeline

  4.3 Phase of Development

 

5. Insulin Glargine Biosimilar - Boehringer Ingelheim/Eli Lilly

  5.1 Clinical Insight

  5.2 Development Timeline

  5.3 Patent Analysis

  5.4 Phase of Development

 

6. Insulin Glargine Biosimilar - Gan & Lee Pharmaceuticals

  6.1 Clinical Insight

  6.2 Development Timeline

  6.3 Phase of Development

 

7. Insulin Glargine Biosimilar – GEROPHARM

  7.1 Clinical Insight

  7.2 Phase of Development

 

8. Insulin Glargine Biosimilar - Harvest Moon Pharmaceuticals

  8.1 Clinical Insight

  8.2 Phase of Development

 

9. Insulin Glargine Biosimilar - LG Life Sciences

  9.1 Clinical Insight

  9.2 Phase of Development

 

10. Insulin Glargine Biosimilar - Paras Biopharmaceuticals

  10.1 Clinical Insight

  10.2 Patent Analysis

  10.3 Phase of Development

 

11. Insulin Glargine Biosimilar - Samsung Bioepis/Merck & Co.

  11.1 Clinical Insight

  11.2 Development Timeline

  11.3 Patent Analysis

  11.4 Phase of Development

 

12. Insulin Glargine Biosimilar – Wockhardt

  12.1 Clinical Insight

  12.2 Development Timeline

  12.3 Phase of Development

 

13. Recombinant Insulin Glargine Biosimilar – Biogenomics

  13.1 Clinical Insight

  13.2 Phase of Development


Table 2-1: Insulin U300 Insulin Glargine by Indicaion & Phase

Table 3-1: HEC Pharm Insulin Glargine by Indication & Phase

Table 4-1: Biocon/Mylan Insulin Glargine Biosimilar by Indication & Phase

Table 5-1: Boehringer Ingelheim/Eli Lilly Insulin Glargine Biosimilar by Indication & Phase

Table 6-1: Gan & Lee Pharmaceuticals Insulin Glargine Biosimilar by Indication & Phase

Table 7-1: GEROPHARM Insulin Glargine Biosimilar by Indication & Phase

Table 8-1: Harvest Moon Pharmaceuticals Insulin Glargine Biosimilar by Indication & Phase

Table 9-1: LG Life Sciences Insulin Glargine Biosimilar by Indication & Phase

Table 10-1: Paras Biopharmaceuticals Insulin Glargine Biosimilar by Indication & Phase

Table 11-1: Samsung Bioepis/Merck & Co. Insulin Glargine Biosimilar by Indication & Phase

Table 12-1: Wockhardt Insulin Glargine Biosimilar by Indication & Phase

Table 13-1: Biogenomics Recombinant Insulin Glargine Biosimilar by Indication & Phase