Figures & data
Figure 1 Insulin molecule (hexamer).
Notes: Copyright © 2014 Hilgenfeld R, Seipke G, Berchtold H, Owens DR. Reproduced from Hilgenfeld R, Seipke G, Berchtold H, Owens DR. The evolution of insulin glargine and its continuing contribution to diabetes care. Drugs. 2014 Jun;74(8):911–927.Citation12
Figure 2 Structures of human insulin (A) and the long-acting basal insulin analogs insulin glargine (B), insulin detemir (C), insulin lispro (D), insulin aspart (E), insulin glulisine (F), and insulin degludec (G).
Table 1 Insulin glargine copy manufacturers
Figure 3 Sources of variation between manufacturers and batches of biosimilar products and reference originals.
Notes: Copyright © 2008 Oxford University Press. Adapted by permission of Oxford University Press. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19(3):411–419.
Table 2 Host systems for insulin manufacture
Figure 4 Manufacture of analog insulin using a bacterial host system.
Figure 5 High-molecular-weight proteins (HMWP) in insulin glargine (original Lantus® and copy products) on direct testing (A) and after simulation of in-use period (28 days at +25°C) (B).
Notes: The sample age in months at the time of analysis is indicated above each column (original data on file at Sanofi). X axis represents different product batches. Glaritus®, Wockhardt Ltd, Mumbai, India; Basalin®, Gan and Lee Pharmaceuticals, Beijing, People’s Republic of China; Lantus®, Sanofi, Paris, France.
Abbreviation: USP, United States Pharmacopeia.
Abbreviation: USP, United States Pharmacopeia.
