Fifty-five per cent of biosimilar opportunities from loss of exclusivity come from just 10% (13) biologicals, which are concentrated in the oncology space, according to a report released by data analysis firm IQVIA [1].
The report, which was carried out at the request of the European Commission, found that this provides large opportunities to make savings and increase access to previously high-cost cancer medications.
Previous IQVIA reports have shown the size of the opportunity available to biosimilar competition in the future peaks around 2027–2028 at €8 billion when PD-1 inhibitors, such as Keytruda (pembrolizumab) and Opdivo (nivolumab), lose their exclusivity [2].
Over the next 10 years, the majority of biologicals losing their exclusivity will be oncology biologicals (29%), followed by biologicals to treat blood and lymphatic conditions (21%), see Figures 1 and 2. Ensuring that physicians working in these areas are aware of biosimilars will be critical to success. However, more importantly, having a sustainable purchasing policy in place that can manage the biosimilars that enter the markets will be critical.
Figure 1: Biologicals expected to lose exclusivity by therapy area
Figure 2: Composition of biologicals expected to lose exclusivity by therapy area
How to manage the fact that most new biosimilars will be in just two areas raises problems. Firstly, how to manage biosimilar introductions in other areas and ensure that biosimilar makers are incentivised to take these smaller opportunities. Secondly, the ‘major molecules’ and the ‘large molecules’ are only 20% of all biologicals losing exclusivity but are twice as many as Europe has experienced since the introduction of biosimilars in 2006 (18 total in 2021).
Conflict of interest
The authors of the report [1] did not provide any conflict-of-interest statement.
Editor’s comment
Readers interested to learn more about loss of exclusivity and biologicals are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
The European framework for intellectual property rights for biological medicines
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References
1. Troein P, Newton M, Scott K, et al. The impact of biosimilar competition in Europe: December 2021. IQVIA.
2. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
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