title: [Practical aspects in the use of biosimilar insulins].
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.
authors.forename: Irene
authors.initials: I
authors.lastname: Krämer
authors.forename: Matthias
authors.initials: M
authors.lastname: Blüher
authors.forename: Martin K
authors.initials: MK
authors.lastname: Kuhlmann
authors.forename: Lutz
authors.initials: L
authors.lastname: Heinemann
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage* / Q000009:adverse effects; D003920:Diabetes Mellitus / Q000000981:diagnostic imaging / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D017277:Drug Approval; D016903:Drug Monitoring / Q000379:methods; D005062:European Union; D019317:Evidence-Based Medicine; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D059451:Biosimilar Pharmaceuticals; D007004:Hypoglycemic Agents; D007328:Insulin