| Title |
EU pharmacovigilance regulatory requirements of anticancer biosimilar monoclonal antibodies
|
|---|---|
| Published in |
International Journal of Clinical Pharmacy, August 2018
|
| DOI | 10.1007/s11096-018-0709-6 |
| Pubmed ID | |
| Authors |
Sara Francescon, Giulia Fornasier, Paolo Baldo |
| Abstract |
An increasing number of innovative oncology monoclonal antibodies (mAbs) have been introduced into the global market, and biosimilar versions have now also been approved in Europe. Being complex to develop and difficult to manufacture, the biosimilar is a drug similar but not identical in physicochemical characteristics, efficacy, and safety to an original biological drug already approved in the European Union, for which marketing exclusivity rights have expired. Generally, the safety monitoring of biosimilars follows the same requirements that apply to all biologicals, even if specific pharmacovigilance measures exist and some of them are still being debated. The manufacturing process, immunogenicity, traceability, and extrapolation of indication are keywords which may impact on the achievement of additional knowledge about the safety of a biosimilar mAb. In this article, we aim to discuss elements that play a central role in the pharmacovigilance legislation of biosimilar mAbs. |
X Demographics
The data shown below were collected from the profiles of 2 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United Kingdom | 1 | 50% |
| Sweden | 1 | 50% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 2 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 50 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 50 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 9 | 18% |
| Student > Master | 9 | 18% |
| Student > Doctoral Student | 4 | 8% |
| Student > Bachelor | 3 | 6% |
| Student > Ph. D. Student | 3 | 6% |
| Other | 6 | 12% |
| Unknown | 16 | 32% |
| Readers by discipline | Count | As % |
|---|---|---|
| Pharmacology, Toxicology and Pharmaceutical Science | 13 | 26% |
| Medicine and Dentistry | 6 | 12% |
| Nursing and Health Professions | 3 | 6% |
| Chemistry | 3 | 6% |
| Agricultural and Biological Sciences | 2 | 4% |
| Other | 7 | 14% |
| Unknown | 16 | 32% |
Attention Score in Context
This research output has an Altmetric Attention Score of 2. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 14 September 2018.
All research outputs
#14,888,076
of 23,099,576 outputs
Outputs from International Journal of Clinical Pharmacy
#770
of 1,109 outputs
Outputs of similar age
#196,496
of 331,391 outputs
Outputs of similar age from International Journal of Clinical Pharmacy
#19
of 28 outputs
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