Biosimilars are essential for sustainable healthcare systems across Europe; however, key challenges remain as seen with biosimilars for long-acting insulin analogues

Godman, Brian and Tubić, Biljana and Allocati, Eleonora and Wladysiuk, Magdalene and McTaggart, Stuart and Kurdi, Amanj and Haque, Mainul and MacBride-Stewart, Sean and Kalemeera, Francis and Massele, Amos and Hoxha, Iris and Marković-Peković, Vanda and Petrova, Guenka and Tachkov, Konstantin and Laius, Ott and Harsanyi, András and Inotai, Andras and Jakupi, Arianit and Henkuzens, Svens and Garuolienė, Kristina and Vella Bonanno, Patricia and Rutkowski, Jakub and Mardare, Ileana and Fürst, Jurij and Pontes, Caridad and Zara, Corinne and Turu Pedrola, Marta and Akter, Farhana and Kwon, Hye-Young and Martin, Antony P and Banzi, Rita and Wale, Janney and Gulbinovic, Jolanta (2022) Biosimilars are essential for sustainable healthcare systems across Europe; however, key challenges remain as seen with biosimilars for long-acting insulin analogues. Journal of Applied Pharmaceutical Science, 12 (3). pp. 55-72. ISSN 2231-3354 (https://doi.org/10.7324/JAPS.2022.120306)

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Abstract

Sales of medicines continue to grow world-wide driven in part by increasing expenditures on biological medicines leading to concerns with the long-term sustainability of European healthcare systems. The increasing use of biosimilars at lower costs can potentially address this. However, there can be concerns with their prescribing. There are also concerns with biosimilar insulin glargine including concerns with different devices despite increasing sales of long-acting insulin analogues worldwide. Consequently, a need to appraise the European biosimilar market incorporating measures to enhance their use including potential ways to increase the prescribing of biosimilars of insulin glargine at lower costs. Multiple approaches were used to undertake the study including measures to enhance biosimilar use and their impact across Europe. In addition, undertake cross national research on the utilization and expenditure of long-acting insulin analogues, which includes biosimilars, principally among Central and Eastern European countries. Multiple demand-side measures across countries have enhanced the use of biosimilars. There was variable use of biosimilar insulin glargine 100IU/ml driven by increasing use of patented 300IU/ml formulations and small price differences between the originator and biosimilars in practice. Overall, multiple demand-side initiatives can appreciably increase biosimilar use benefiting all groups. Additional measures are needed to enhance future prescribing of long-acting biosimilar insulin analogues.

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