Regulatorische Aspekte zu Biosimilars
| Autor: | C K Schneider, M Weise |
|---|---|
| Rok vydání: | 2015 |
| Předmět: |
medicine.medical_specialty
business.industry media_common.quotation_subject Alternative medicine Biosimilar Biotechnology Biosimilar Pharmaceuticals Rheumatology Government regulation Agency (sociology) medicine media_common.cataloged_instance Engineering ethics Quality (business) Product (category theory) European union business media_common |
| Zdroj: | Zeitschrift für Rheumatologie. 74:695-700 |
| ISSN: | 1435-1250 0340-1855 |
| Popis: | Background Biosimilars are currently a hot topic and there are many unsolved questions, misunderstandings and sometimes considerable uncertainty, especially among clinicians and patients. Regulatory agencies, such as the European Medicines Agency (EMA) issue guidelines for the development and approval of biosimilars, which are based on scientific principles. Objective This article addresses some of the frequently noted misunderstandings and misperceptions. For example, why biosimilars are (or can only be) "similar" but not "identical" compared to the original pharmaceutical product, and aspects, such as the pharmaceutical quality of biosimilars, immunogenicity and the approval process for biosimilars are highlighted. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full text from SpringerLink