Terminology for biosimilars–a confusing minefield
Journal Title: Generics and Biosimilars Initiative Journal - Year 2012, Vol 1, Issue 3
Abstract
Biosimilars are firmly established in the EU as copy biologicals with a clear and effective regulatory route for approval. Unfortunately, inconsistency in nomenclature for biosimilars has caused confusion. This problem of terminology has been the subject of a recent publication. The confusion is not just a potential concern for patient safety and efficacy, but also can lead to misconceptions in published reports. Several examples of this have occurred, some of which are discussed below. The definitions provided should be adopted for clarity in the future.
Authors and Affiliations
Robin Thorpe, Meenu Wadhwa
Keywords
Related Articles
- EP ID EP355646
- DOI 10.5639/gabij.2012.0103-4.023
- Views 110
- Downloads 0
Defining and characterizing non-biological complex drugs (NBCDs) – Is size enough? The case for liposomal doxorubicin generics (‘liposomal nanosimilars’) for injection
‘Non-binding recommendations’ from regulatory bodies are in place for evaluation and production of generic liposomal doxorubicin injection. However, how these nano-sized generics (‘nanosimilars’) should be characterized...
Oncologists urged to embrace biosimilars to help control spiralling costs of cancer care
Oncologists urged to embrace biosimilars to help control spiralling costs of cancer care Oncologists have been urged to embrace biosimilar drug substitution to help control the spiralling costs of cancer care. However, t...
How matrix models can support generic medicine prescribing
This paper describes the design of currently available matrix models and assesses the experience with these models to date. Matrix models provide a valuable tool to facilitate transparent and interactive evidence-based m...
What to look forward to in GaBI Journal, 2013, Issue 2
The first of two Letters to the Editor is from Ms Gaspani and Ms Milani expressing their concerns about the lack of clear regulatory guidelines for approval of liposomal generic formulations. Liposomal products are only...
Biosimilars naming and prescribing policy in Australia
To the Editor: I wanted to bring to your attention the following paper which was published in Volume 2/Year 2013/Issue 3 of the Generics and Biosimilars Initiative Journal. The Perspective paper titled Licensing and pr...