The European Commission held a stakeholder event to discuss biosimilar medicinal products in May 2017. A session on building stakeholder confidence in biosimilar medicines provided an update of the latest available clinical experiences with biosimilar medicines, focusing on switching between biological medicines and interchangeability. Assistant Professor Gianluca Trifirò from the University of Messina, Italy, discussed these issues from the perspective of physicians in Italy.
Submitted: 23 October 2017; Revised: 6 November 2017; Accepted: 7 November 2017; Published online first: 20 November 2017
As both clinical experience and real-world evidence increases, knowledge sharing and identifying best practices can support the appropriate use of biologicals, including biosimilar medicines. Gianluca Trifirò, Assistant Professor of Pharmacology at the University of Messina and a Clinical Pharmacologist in the Unit of Clinical Pharmacology of the Academic Hospital ‘G. Martino’ of Messina, Italy provided an update of the latest available clinical experiences with biosimilar medicines in Italy, focusing on switching between biological medicines and interchangeability. He provided clarity on the European Crohn’s Colitis Organisation (ECCO) position on the use of biosimilars for inflammatory bowel disease (IBD) and discussed the challenges ahead [1, 2].
EC stakeholder event
The European Commission (EC) held a stakeholder event to discuss biosimilar medicinal products in May 2017. A session on building stakeholder confidence in biosimilar medicines at this event provided an update of the latest available clinical experiences with biosimilar medicines, focusing on switching between biological medicines and interchangeability.
Professor Trifirò discussed the issue of stakeholder confidence from the perspective of physicians in Italy. He reported the results of a survey of 816 Italian physicians including their experience with regional or national drug policies and how this has affected their prescribing behaviour.
In addition, Professor Trifirò presented the conclusions of an updated position statement from ECCO on the use of biosimilars for IBD. He concluded his presentation by looking at the future challenges facing biosimilar uptake in Italy and worldwide and how these challenges should be met.
Italian physician survey
Professor Trifirò presented the results of a survey involving 816physicians in Italy  and which was coordinated by Cittadinanzattiva that is a non-profi t organization which is aimed at promoting civic participation and protection of citizens’ rights in Italy. The survey questionnaire was developed in a roundtable with representatives of several Italian scientific societies and patient and physicians organizations. The same roundtable participants distributed the survey questionnaire electronically using the web platform ‘esurveypro’ through a dedicated link through mailing, newsletter, Internet and participation at events and conventions.
The physicians, who worked across a range of specialties, see Table 1, were asked whether the way that they prescribe medicines was influenced by regional or national drug policies.
Physicians were asked whether they had ever prescribed a medicine that they did not consider was the best available option in order to conform to regional or national drug policies, see Figure 1, there was no response for ‘Always’.
ECCO position statement on the use of biosimilars for IBD
Professor Trifirò presented a position statement on the use of biosimilars for IBD released in 2017 by ECCO [1, 2]. The statement is the result of a consensus meeting held on 15 October 2016 and is based on the current regulatory guidance from the European Medicines Agency and evidence about efficacy and safety of biosimilars in IBD patients, see Box 1.
Several challenges for the future of biosimilars were identified. Establishing an effective system of pharmacovigilance will be key. The first challenge highlighted by Professor Trifirò will be to explore comparative long-term safety and effectiveness of first generation biosimilars thanks to data that have been cumulated over time.
Table 1 pending to upload
Figure 1 pending to upload
Box 1 pending to upload
As experience with biosimilars grows, it will be important to evaluate clinical effects of switch between originator and biosimilars and vice versa, and between different originators.
Alongside these challenges, the secondary use of healthcare databases for post-marketing surveillance needs to be considered also for second-gene ration biosimilars in cancer patients.
While promoting the use of low cost biologicals, warned Professor Trifirò, prescribing biologicals wisely remains the highest priority over cost considerations. Every stakeholder (payers, healthcare professionals, patients) needs to be involved in the collection of real-world evidence about biosimilars that has to be integrated with pre-marketing evidence from randomized clinical trials .
Professor Trifirò concluded by noting that, given the growing number of biosimilars to be marketed in the near future across several different therapeutic areas, an international postmarketing surveillance system specifi cally for biosimilars must be established .
The author wishes to thank Dr Bea Perks, GaBI Journal Editor, in preparing this Special Report manuscript.
Competing interests: None.
Provenance and peer review: Not commissioned; internally peer reviewed.
Assistant Professor Gianluca Trifirò1,2, MD, PhD
1Unit of Clinical Pharmacology, Azienda Ospedaliera Universitaria, Farmacologo Clinico, Policlinico ‘G Martino’, Dipartimento di Medicina, Clinica e Sperimentale, 1 Via Consolare Valeria, IT-98125 Messina, Italy
2Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, 1 Via Consolare Valeria, IT-98125 Messina, Italy
References pending to upload
Disclosure of Conflict of Interest Statement is available upon request.
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