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Pharmacovigilance of biosimilars and other biologicals within the hospital : current practices and future challenges

Barbara Claus (UGent) , Tieneke Bauters (UGent) and Annemie Somers (UGent)
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Abstract
In the coming decade, many patents for biological pharmaceuticals will expire. Consequently, the market for biosimilars has the potential to grow rapidly. For safety reasons, the more extensive use of a greater variety of biologicals increases the importance of adequate traceability of each administered product and batch. In essence, accurate pharmacovigilance and post-marketing surveillance are needed. This paper summarizes the associated challenges faced by hospitals, and their role in the current and future pharmacovigilance of biosimilars and other biologicals. Recent experience at the Ghent University Hospital in Belgium is described to provide an example of the contribution hospitals can make to the improved pharmacovigilance of biologicals.
Keywords
Biologicals, biosimilars, hospitals, pharmacovigilance, TRACEABILITY, EUROPE

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Citation

Please use this url to cite or link to this publication:

MLA
Claus, Barbara, Tieneke Bauters, and Annemie Somers. “Pharmacovigilance of Biosimilars and Other Biologicals Within the Hospital : Current Practices and Future Challenges.” GABI JOURNAL-GENERICS AND BIOSIMILARS INITIATIVE JOURNAL 6.1 (2017): 24–26. Print.
APA
Claus, B., Bauters, T., & Somers, A. (2017). Pharmacovigilance of biosimilars and other biologicals within the hospital : current practices and future challenges. GABI JOURNAL-GENERICS AND BIOSIMILARS INITIATIVE JOURNAL, 6(1), 24–26.
Chicago author-date
Claus, Barbara, Tieneke Bauters, and Annemie Somers. 2017. “Pharmacovigilance of Biosimilars and Other Biologicals Within the Hospital : Current Practices and Future Challenges.” Gabi Journal-generics and Biosimilars Initiative Journal 6 (1): 24–26.
Chicago author-date (all authors)
Claus, Barbara, Tieneke Bauters, and Annemie Somers. 2017. “Pharmacovigilance of Biosimilars and Other Biologicals Within the Hospital : Current Practices and Future Challenges.” Gabi Journal-generics and Biosimilars Initiative Journal 6 (1): 24–26.
Vancouver
1.
Claus B, Bauters T, Somers A. Pharmacovigilance of biosimilars and other biologicals within the hospital : current practices and future challenges. GABI JOURNAL-GENERICS AND BIOSIMILARS INITIATIVE JOURNAL. 2017;6(1):24–6.
IEEE
[1]
B. Claus, T. Bauters, and A. Somers, “Pharmacovigilance of biosimilars and other biologicals within the hospital : current practices and future challenges,” GABI JOURNAL-GENERICS AND BIOSIMILARS INITIATIVE JOURNAL, vol. 6, no. 1, pp. 24–26, 2017.
@article{8526227,
  abstract     = {In the coming decade, many patents for biological pharmaceuticals will expire. Consequently, the market for biosimilars has the potential to grow rapidly. For safety reasons, the more extensive use of a greater variety of biologicals increases the importance of adequate traceability of each administered product and batch. In essence, accurate pharmacovigilance and post-marketing surveillance are needed. This paper summarizes the associated challenges faced by hospitals, and their role in the current and future pharmacovigilance of biosimilars and other biologicals. Recent experience at the Ghent University Hospital in Belgium is described to provide an example of the contribution hospitals can make to the improved pharmacovigilance of biologicals.},
  author       = {Claus, Barbara and Bauters, Tieneke and Somers, Annemie},
  issn         = {2033-6403},
  journal      = {GABI JOURNAL-GENERICS AND BIOSIMILARS INITIATIVE JOURNAL},
  keywords     = {Biologicals,biosimilars,hospitals,pharmacovigilance,TRACEABILITY,EUROPE},
  language     = {eng},
  number       = {1},
  pages        = {24--26},
  title        = {Pharmacovigilance of biosimilars and other biologicals within the hospital : current practices and future challenges},
  url          = {http://dx.doi.org/10.5639/gabij.2017.0601.005},
  volume       = {6},
  year         = {2017},
}

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