A report carried out at the request of the European Commission found that the development of access to biologicals in Europe remains challenging [1].
The report, which was carried out by data analysis firm IQVIA, found that the competitive environment in Europe for biosimilars is changing.
When originator biologicals lose patent protection there are increasingly rapid biosimilar penetration rates. In fact, biosimilars launched in the past year have reached 50% penetration of the originator within less than one year. This compares to previous biosimilars, which took more than two years to reach an equivalent position and older biosimilars, which still have lower penetration.
Biosimilar makers are much more prepared for immediate launch upon loss of exclusivity and there are also more biosimilar manufacturers entering the market.
The European biosimilar market has benefited from research by a broad spectrum of companies from across the globe, willing and able to develop complex biologicals. The history of the market has been European dominated, with leading generics’ makers like Sandoz, Ratiopharm and Hexal leading the first wave of biosimilar development, alongside global players like Teva and Cipla. This trend is changing as other regions enter the biosimilar space, resulting in growth internationally and the emergence of new players that are preparing to launch their first biosimilars.
The problem with non-originator products approved outside of the European Union (EU) is that the regulatory and development processes are not directly interchangeable between regions. European Medicines Agency (EMA) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product. While another problem for potential biosimilars makers from outside the EU are the somewhat opaque rebate and discount procedures.
Finally, the high upfront investment and production costs coupled with pricing pressures and limited access are raising the bar for biosimilar developers and may make Europe more dependent on imported medicines.
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 biosimilar competition in Europe are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Biosimilar competition in Europe
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Reference
1. Troein P, Newton M, Scott K, et al. The impact of biosimilar competition in Europe: December 2021. IQVIA.
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