1. [Practical aspects in the use of biosimilar insulins].
- Author
-
Krämer I, Blüher M, Kuhlmann MK, and Heinemann L
- Subjects
- Biosimilar Pharmaceuticals adverse effects, Diabetes Mellitus diagnostic imaging, Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Monitoring methods, European Union, Evidence-Based Medicine, Humans, Hypoglycemic Agents administration & dosage, Hypoglycemic Agents adverse effects, Insulin adverse effects, Treatment Outcome, Biosimilar Pharmaceuticals administration & dosage, Diabetes Mellitus drug therapy, Drug Approval, Insulin administration & dosage
- Abstract
Following the market authorization of the first insulin biosimilar in 2014, further approvals are to be expected due to patent expiry of several originator insulins. Knowledge of the manufacturing and the characteristics of these pharmaceutical products is important for their rationale and safe use by the physician, the pharmacist and the patient.Biosimilars are not generics, but similar or comparable, yet not identical versions of the originator biopharmaceutical. Marketing authorization in the EU is granted only after passing a stringent procedure. So far, there is no evidence of problems specifically associated with insulin biosimilars. However, shifting a patient from an originator insulin to a biosimilar (or vice versa) should be done with care and under close monitoring. Automatic substitution of biosimilars in the pharmacy is not permitted in Germany. Administration devices also have a significant impact on safe use., (© Georg Thieme Verlag KG Stuttgart · New York.)
- Published
- 2016
- Full Text
- View/download PDF