A bioethicist’s view of the use of biosimilars
Journal Title: Generics and Biosimilars Initiative Journal - Year 2012, Vol 1, Issue 3
Abstract
In recognition of the many ethically sensitive issues raised by the production and use of biosimilar medicinal products, the author imagines having to answer the non-multiple choice question ‘From the ethical point of view, what is the most important issue raised by biosimilars?’, and endeavours to explain why the proposed answer is ‘safety’.
Authors and Affiliations
Carlo Petrini
Keywords
Related Articles
- EP ID EP355623
- DOI 10.5639/gabij.2012.0103-4.034
- Views 108
- Downloads 0
What lessons can be learned from the launch of generic clopidogrel?
Introduction and study objectives: Resource pressures will continue to grow. Consequently, health authorities and health insurance agencies need to take full advantage of the availability of generics in order to continue...
Austria increases dialogue in order to involve physicians more with biosimilars
Comment on the GaBI Journal article titled The potential for doctors to contribute to biosimilar guidelines [1] and the GaBI Online article titled Dialogue needed to build confidence in biosimilars [2], both by GaBI Jour...
Latest features in GaBI Journal, 2013, Issue 3
The GaBI Journal again contains manuscripts covering a wide range of pertinent topics. In an Editorial, Dr Gianluigi Casadei reviews Italy’s final position paper on biosimilars including the new price and reimbursement p...
Access to liposomal generic formulations: beyond AmBisome and Doxil/Caelyx
The lack of clear regulatory guidance remains a key bottleneck for securing a second quality-assured source of liposomal amphotericin B (LAmB), the WHO-recommended drug for visceral leishmaniasis. The approval of the fir...
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...