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GLARGINE PRODUCT SUMMARY Insulin Glargine Is Mainly Used for the Treatment of Type 1 Diabetes (Where the Body Does Not Produce Enough Insu- Lin)

GLARGINE PRODUCT SUMMARY Insulin Glargine Is Mainly Used for the Treatment of Type 1 Diabetes (Where the Body Does Not Produce Enough Insu- Lin)

INSULIN GLARGINE PRODUCT SUMMARY glargine is mainly used for the treatment of type 1 diabetes (where the body does not produce enough insu- lin). It is also used to treat type 2 diabetics who need insulin to control their diabetes. Glargine works by replacing the insulin that is normally produced by the body and help move sugar from the blood into other body tissues where it is used for energy. A single subcutaneous injection is administered daily into the thigh or abdominal wall. Paras Products BRAND NAME: Lantus® by Sanofi, France

ACTIVE INGREDIENT: [rDNA origin] Forteo (Recombinant Teriparatide)

DESCRIPTION: Recombinant human insulin analogue Victoza Biosimilar (Recombinant )

TARGET GROUP: Treatment of type 1 (adult and children) & type 2 (adult) diabetes mellitus Novolog Biosimilar ()

PRODUCT PATENT EXPIRY: 2015 Kineret Biosimilar (Anakinra) Recombinant Enterokinase

LANTUS BIOSIMILAR (GLARGINE) Phone : +358 (0) 4427 09462 Skype : Paras.Finland Address: E-mail : [email protected] Paras Biopharmaceuticals Finland Oy Web: www.parasbiopharma.com Kiviharjunlenkki 2 www.parasbiopharma.com Oulu, FI-90220, Finland Global Burden of Diabetes Glargine Action

Of the estimated 382 million diabetics in the world today Insulin glargine is a recombinant long-acting human insulin analogue approved for the treatment of Glargine has the following actions: (2013), the majority are aged between 40 and 59 of which adult and pediatric patients with type 1 diabetes mellitus (a condition which the body does not pro- 80% live in low- and middle-income countries (IDF). China duce insulin and therefore, can not control the amount of sugar in the blood) or adult patients with • Glargine is soluble at acidic pH values. and India alone account for 42.8% of diabetics worldwide. type 2 mellitus. • When injected subcutaneously the acidic solution is By 2035, 1 in 10 adults will have diabetes. This equates to neutralised leading to micro-precipitates. approx 3 new cases every 10 seconds, or 10 million a year. Recombinant glargine is a 53 amino A single daily subcutaneous injection • Glargine is slowly released from these acid containing three disulfide (via an injection pen or syringe) whose precipitates. What is Diabetes? bonds, whose molecular weight is dosage varies depending on the indi- 6063 D. vidual needs of the patient. • Onset of action is just over 1 hour. Diabetes is a chronic disease that occurs when the body • Constant concentration / time profile for can not produce enough insulin or use insulin effectively. 24 hours. Normally, insulin is produced by the pancreas to convert Patents currently exist in the United Glargine differs from human insulin States and several European coun- with modifications at the carboxy-ter- glucoses into energy however, in a diabetic, glucoses are • Once daily dosing as a patient’s basal not absobed properly and remain circulating in the blood tries (France, Germany, Spain and UK) minus at the ends of both the A- and insulin. (hyperglycaemia). which are expected to expire in 2015. B-chains. • Glucose-lowering effect of glargine is There are three types of diabetes: Stored between 2 - 8oC, glargine is administered subcutaneously into the thigh, abdominal wall or approximately the same as human insulin. Dotted circles highlight the modifica- • type 1 diabetes deltoid. Once open, the solution has a shelf-life of 4 weeks. tions of human insulin at the c-terminal • type 2 diabetes ends of both the A- and B-chains to • gestational diabetes obtain glargine.

DIABETES CAUSED 5.1 MILLION DEATHS IN 2013. EVERY 6 SECONDS SOMEONE DIES FROM DIABETES. Global Burden of Diabetes Glargine Action

Of the estimated 382 million diabetics in the world today Insulin glargine is a recombinant long-acting human insulin analogue approved for the treatment of Glargine has the following actions: (2013), the majority are aged between 40 and 59 of which adult and pediatric patients with type 1 diabetes mellitus (a condition which the body does not pro- 80% live in low- and middle-income countries (IDF). China duce insulin and therefore, can not control the amount of sugar in the blood) or adult patients with • Glargine is soluble at acidic pH values. and India alone account for 42.8% of diabetics worldwide. type 2 mellitus. • When injected subcutaneously the acidic solution is By 2035, 1 in 10 adults will have diabetes. This equates to neutralised leading to micro-precipitates. approx 3 new cases every 10 seconds, or 10 million a year. Recombinant glargine is a 53 amino A single daily subcutaneous injection • Glargine is slowly released from these acid peptide containing three disulfide (via an injection pen or syringe) whose precipitates. What is Diabetes? bonds, whose molecular weight is dosage varies depending on the indi- 6063 D. vidual needs of the patient. • Onset of action is just over 1 hour. Diabetes is a chronic disease that occurs when the body • Constant concentration / time profile for can not produce enough insulin or use insulin effectively. 24 hours. Normally, insulin is produced by the pancreas to convert Patents currently exist in the United Glargine differs from human insulin States and several European coun- with modifications at the carboxy-ter- glucoses into energy however, in a diabetic, glucoses are • Once daily dosing as a patient’s basal not absobed properly and remain circulating in the blood tries (France, Germany, Spain and UK) minus at the ends of both the A- and insulin. (hyperglycaemia). which are expected to expire in 2015. B-chains. • Glucose-lowering effect of glargine is There are three types of diabetes: Stored between 2 - 8oC, glargine is administered subcutaneously into the thigh, abdominal wall or approximately the same as human insulin. Dotted circles highlight the modifica- • type 1 diabetes deltoid. Once open, the solution has a shelf-life of 4 weeks. tions of human insulin at the c-terminal • type 2 diabetes ends of both the A- and B-chains to • gestational diabetes obtain glargine.

DIABETES CAUSED 5.1 MILLION DEATHS IN 2013. EVERY 6 SECONDS SOMEONE DIES FROM DIABETES. Global Burden of Diabetes Glargine Action

Of the estimated 382 million diabetics in the world today Insulin glargine is a recombinant long-acting human insulin analogue approved for the treatment of Glargine has the following actions: (2013), the majority are aged between 40 and 59 of which adult and pediatric patients with type 1 diabetes mellitus (a condition which the body does not pro- 80% live in low- and middle-income countries (IDF). China duce insulin and therefore, can not control the amount of sugar in the blood) or adult patients with • Glargine is soluble at acidic pH values. and India alone account for 42.8% of diabetics worldwide. type 2 mellitus. • When injected subcutaneously the acidic solution is By 2035, 1 in 10 adults will have diabetes. This equates to neutralised leading to micro-precipitates. approx 3 new cases every 10 seconds, or 10 million a year. Recombinant glargine is a 53 amino A single daily subcutaneous injection • Glargine is slowly released from these acid peptide containing three disulfide (via an injection pen or syringe) whose precipitates. What is Diabetes? bonds, whose molecular weight is dosage varies depending on the indi- 6063 D. vidual needs of the patient. • Onset of action is just over 1 hour. Diabetes is a chronic disease that occurs when the body • Constant concentration / time profile for can not produce enough insulin or use insulin effectively. 24 hours. Normally, insulin is produced by the pancreas to convert Patents currently exist in the United Glargine differs from human insulin States and several European coun- with modifications at the carboxy-ter- glucoses into energy however, in a diabetic, glucoses are • Once daily dosing as a patient’s basal not absobed properly and remain circulating in the blood tries (France, Germany, Spain and UK) minus at the ends of both the A- and insulin. (hyperglycaemia). which are expected to expire in 2015. B-chains. • Glucose-lowering effect of glargine is There are three types of diabetes: Stored between 2 - 8oC, glargine is administered subcutaneously into the thigh, abdominal wall or approximately the same as human insulin. Dotted circles highlight the modifica- • type 1 diabetes deltoid. Once open, the solution has a shelf-life of 4 weeks. tions of human insulin at the c-terminal • type 2 diabetes ends of both the A- and B-chains to • gestational diabetes obtain glargine.

DIABETES CAUSED 5.1 MILLION DEATHS IN 2013. EVERY 6 SECONDS SOMEONE DIES FROM DIABETES. INSULIN GLARGINE PRODUCT SUMMARY Insulin glargine is mainly used for the treatment of type 1 diabetes (where the body does not produce enough insu- lin). It is also used to treat type 2 diabetics who need insulin to control their diabetes. Glargine works by replacing the insulin that is normally produced by the body and help move sugar from the blood into other body tissues where it is used for energy. A single subcutaneous injection is administered daily into the thigh or abdominal wall. Paras Products BRAND NAME: Lantus® by Sanofi, France

ACTIVE INGREDIENT: Insulin glargine [rDNA origin] Forteo Biosimilar (Recombinant Teriparatide)

DESCRIPTION: Recombinant human insulin analogue Victoza Biosimilar (Recombinant Liraglutide)

TARGET GROUP: Treatment of type 1 (adult and children) & type 2 (adult) diabetes mellitus Novolog Biosimilar (Insulin Aspart)

PRODUCT PATENT EXPIRY: 2015 Kineret Biosimilar (Anakinra) Recombinant Enterokinase

LANTUS BIOSIMILAR (GLARGINE) Phone : +358 (0) 4427 09462 Skype : Paras.Finland Address: E-mail : [email protected] Paras Biopharmaceuticals Finland Oy Web: www.parasbiopharma.com Kiviharjunlenkki 2 www.parasbiopharma.com Oulu, FI-90220, Finland INSULIN GLARGINE PRODUCT SUMMARY Insulin glargine is mainly used for the treatment of type 1 diabetes (where the body does not produce enough insu- lin). It is also used to treat type 2 diabetics who need insulin to control their diabetes. Glargine works by replacing the insulin that is normally produced by the body and help move sugar from the blood into other body tissues where it is used for energy. A single subcutaneous injection is administered daily into the thigh or abdominal wall. Paras Products BRAND NAME: Lantus® by Sanofi, France

ACTIVE INGREDIENT: Insulin glargine [rDNA origin] Forteo Biosimilar (Recombinant Teriparatide)

DESCRIPTION: Recombinant human insulin analogue Victoza Biosimilar (Recombinant Liraglutide)

TARGET GROUP: Treatment of type 1 (adult and children) & type 2 (adult) diabetes mellitus Novolog Biosimilar (Insulin Aspart)

PRODUCT PATENT EXPIRY: 2015 Kineret Biosimilar (Anakinra) Recombinant Enterokinase

LANTUS BIOSIMILAR (GLARGINE) Phone : +358 (0) 4427 09462 Skype : Paras.Finland Address: E-mail : [email protected] Paras Biopharmaceuticals Finland Oy Web: www.parasbiopharma.com Kiviharjunlenkki 2 www.parasbiopharma.com Oulu, FI-90220, Finland