August 2015 Australian Public Assessment Report for Insulin glargine

Attachment 1. Product Information

The Product Information approved for main Abasria at the time this AusPAR was published is at Attachment 1. For the most recent Product Information please refer to the TGA website at .

Attachment 2. Extract from the Clinical Evaluation Report

Therapeutic Goods Administration

PO Box 100 Woden ACT 2606 Australia Email: [e-mail] Phone: [phone] Fax: [phone] https://www.tga.gov.au

1^With a subsequent application, which followed the TGA’s evaluation and approval of this application, the registered names were amended on the Australian Register of Therapeutic Goods (ARTG) to:

• 
  Basaglar KwikPen insulin glargine (rbe) 100 IU/mL solution for injection ARTG 2155552 cartridge and
  
• 
  Basaglar insulin glargine (rbe) 100 IU/mL solution for injection cartridge ARTG 215551.
  

2^ EMEA/CHMP/BMWP/32775/2005_Rev.2 Draft guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues

3^EMEA/CHMP/BMWP/32775/2005 Rev 1. Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues

4^European Medicines Agency. Press release: Marvel Life Sciences Ltd withdraws its marketing authorisation applications for Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel. 16 January 2008. EMEA/2435/2008. London: EMA, 2008

5^ Annex to Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-clinical and Clinical Issues. Guidance on Similar Medicinal Products Containing Recombinant Human Insulin EMEA/CHMP/BMWP/32775/2005

6^Yasaki S. and Dyck PJ. (1990) Duration and severity of hypoglycemia needed to induce neuropathy. Brain Res. 531: 8–15.

Sugimoto K., Baba M., Suda T., Yasujima M. and Yagihashi S. (2003) Peripheral neuropathy and microangiopathy in rats with insulinoma: association with chronic hyperinsulinemia. Diabetes Metab. Res. Rev. 19: 392–400.

Géloën A., Collet A.J., Guay G. and Bukowiecki L.J. (1989) Insulin stimulates in vivo cell proliferation in white adipose tissue. Am. J. Physiol. 256: C190–C196.

Fujikura J., Fujimoto M., Yasue S., Noguchi M., Masuzaki H., Hosoda K., Tachibana T., Sugihara H. and Nakao K. (2005) Insulin-induced lipohypertrophy: report of a case with histopathology. Endocr. J. 52: 623–628.

Blume N., Skouv J., Larsson L.I., Holst J.J. and Madsen O.D. (1995) Potent inhibitory effects of transplantable rat glucagonomas and insulinomas on the respective endogenous islet cells are associated with pancreatic apoptosis. J. Clin. Invest. 96: 2227–2235.

Koranyi L., James D.E., Kraegen E.W. and Permutt M.A. (1992) Feedback inhibition of insulin gene expression by insulin. J. Clin. Invest. 89: 432–436

7^Category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

8^Hemkens LG, Grouven U, Bender R, Günster C, Gutschmidt S, Selke GW, Sawicki PT. Risk of malignancies in patients with diabetes treated with human insulin or insulin analogues: a cohort study. Diabetologia 009; 52:1732–1744.

9^ Schober, E, Schoenle E, Van Dyk J and Wernicke-Panten K, Comparative Trial Between Insulin Glargine and NPH Insulin in Children and Adolescents With Type 1 Diabetes. Letters Diabetes Care, Volume 24, Number 11, 2005 November 2001

10^ Danne T, Philotheou A, Goldman D, Guo X, Ping L, Cali A, Johnston P. A randomized trial comparing the rate of hypoglycemia-assessed using continuous glucose monitoring-in 125 preschool children with Type 1 diabetes treated with insulin glargine or NPH insulin (the PRESCHOOL study). Pediatric Diabetes. 2013;14(8):593-601.

11^ EMEA/CHMP/BMWP/32775/2005_Rev.2

12^ Schober E, Schoenie E, Van Dyk J, Wernicke-Panten K, Pediatric Study Group of Insulin Glargine. Comparative trial between insulin glargine and NPH insulin in children and adolescents with Type 1 diabetes mellitus. J Pediatr Endocrinol Metab. 2002;15(4):369-376.

Alemzadeh R, Berhe T, Wyatt DT. Flexible insulin therapy with glargine insulin improved glycemic control and reduced severe hypoglycemia among preschool-aged children with Type 1 diabetes mellitus. Pediatrics. 2005;115(5):1320-1324.

Danne T, Philotheou A, Goldman D, Guo X, Ping L, Cali A, Johnston P. A randomized trial comparing the rate of hypoglycemia-assessed using continuous glucose monitoring-in 125 preschool children with Type 1 diabetes treated with insulin glargine or NPH insulin (the PRESCHOOL study). Pediatric Diabetes. 2013;14(8):593-601.

NCT00993473 resource page. ClinicalTrials.gov web site. Available at http://clinicaltrials.gov/ct2/show/NCT00993473. Accessed September 10, 2014.