A study of adverse drug reactions reported in Italy has shown no difference between the number and type of side effects reported for biosimilars and their corresponding originators [1].
The benefit–risk profile of biosimilars has been questioned. Therefore, in order to see if there was any increased risk with the use of biosimilars, researchers from the Clinical Pharmacology Unit at the University of Messina, Italy carried out a comparative safety evaluation of biologicals and biosimilars in clinical practice [1].
Using the Italian national spontaneous reporting system database, which is managed by the Italian Medicines Agency (AIFA), Cutroneo and co-authors selected and analyzed adverse drug reaction (ADR) reports that included at least one biological/biosimilar drug during the period 1 January 2001 to 30 June 2013. Biosimilars are currently available in Italy for only three biological products: epoetin alfa, filgrastim and somatropin.
Of the 171,201 ADR reports collected, 9,601 (5.6%) were related to biologicals and 161,600 were reported for all other drugs (the reference group). ADRs for biologicals were more frequently reported by hospital-based physicians (78.7%); while the contribution of these clinicians for non-biological-related ADR reporting was lower (49.0%). On the other hand, general practitioners accounted for 16.9% of non-biological related ADR reports and 2.0% for biologicals.
Among the ADRs reported, 135 reports were related to biosimilars (45.3%) and 160 reports (53.7%) concerned their corresponding originator drugs. Most of the ADR reports related to originators and biosimilars were sent by hospital-based physicians (71.9% for originators, 79.3% for biosimilars), which is in line with the overall results.
Comparison of the nature of the suspected ADRs showed no relevant differences between suspected ADRs reported for biosimilars and originators of the three biologicals with an expired patent (epoetin alfa, filgrastim, somatropin). Most ADRs attributed to biologicals were ‘skin and subcutaneous tissue disorders’. Anticancer monoclonal antibodies were the biologicals most frequently associated with ADRs.
In terms of traceability, 94.8% of biological-related reports included an identifiable product name, whilst only 8.6% indicated the corresponding batch number. Whereas for biologicals with an expired patent the brand-name of the product was present in 98.7% of reports and a batch number in 13.4%. This further highlights the need for the careful documentation of both the brand name and batch number [2].
Conflict of interest
Professor Achille P Caputi has received consulting fees that are not related to the content of this study from the following pharmaceutical companies: Bristol-Myers-Squibb, Otsuka, Novartis, Teva and Novo Nordisk. Paola M Cutroneo, Valentina Isgrò, Alessandra Russo, Valentina Ientile, Laura Sottosanti, Giuseppe Pimpinella, Anita Conforti, Ugo Moretti, and Gianluca Trifirò have no conflicts of interest that are directly relevant to the content of this study.
Editor’s comment
Readers interested to learn more about biosimilars are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:
Biosimilars versus ‘biobetters’ — a regulator’s perspective
Safety assessment of biosimilars in Europe: a regulatory perspective
Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal platform – please send us your submission here.
If you would like to receive a PDF copy* of the Cutroneo et al. paper [1], please send us an email.
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References
1. Cutroneo PM, et al. Safety profile of biological medicines as compared with non-biologicals: an analysis of the italian spontaneous reporting system database. Drug Saf. 2014;37(11):961-70.
2. Laslop A. Biosimilar monoclonal antibodies—challenges and opportunities in Europe. Generics and Biosimilars Initiative Journal (GaBI Journal). 2013;2(3):110-1. doi:10.5639/gabij.2013.0203.034
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