Biosimilar market penetration has been slower than that of generics but the market share of biosimilars has grown over time, according to the authors of a study on biosimilar use in the European Union (EU).
Biosimilar market penetration has been slower than that of generics but the market share of biosimilars has grown over time, according to the authors of a study on biosimilar use in the European Union (EU). Their research found that following introduction, biosimilar market share has grown an average of 2% per quarter in the retail market and by 3.6% per quarter in the hospital market.
The study also reported heterogeneity in market diffusion across countries, which the authors said is likely due to differences in policy measures. Although approval of biosimilars is centralized in the EU, and biosimilars are considered interchangeable by the European Medicines Agency, decisions on interchangeability and substitution are made by individual countries. Most EU member states do not allow automatic substitution of a biosimilar for its originator, the authors noted.
Despite policy measures in many European countries to limit drug spending, there are “substantial barriers” for biosimilars to compete with their reference products compared to generics, the authors wrote. These barriers include a more complex manufacturing process, “more demanding” requirements for approval, intellectual property rights, limited automatic substitution, limited knowledge about biosimilars on the part of physicians, and a lack of incentives for payers, prescribers, and patients. “Thus, it remains unclear to what extent biosimilars will promote competition in the off-patent biologic market,” they said.
The authors used revenue and sales data from IQVIA on 12 originator biologics including rituximab, trastuzumab, infliximab, and insulin glargine in 25 European markets. These biologics were subject to first biosimilar competition between 2014 and 2020.
On average, the market share of biosimilars at market entry was 7.5% and 7.0% in the retail and hospital markets, and grew to 22.0% and 29.0% after four quarters and 35.0% and 38.0% after 16 quarters. The authors noted large standard deviations which “reflect the heterogeneity across countries and substances.” There was a wide range of market share at first entry for different molecules in different countries, from less than 1.0% for enoxaparin sodium in Germany to over 99.0% for infliximab in Lithuania.
There was a small increase in the average number of biosimilar manufacturers over time, from 1.26 and 1.39 in quarter 1 to 2.43 and 2.84 in quarter 16 in the retail and hospital markets. Biosimilars were priced on average at about 73.0% of the price of the originator at market entry in both retail and hospital markets, which decreased to 55.0% in the retail market and 64.0% in the hospital market after 16 quarters. Over the same time period, the price of originators went from 96.0% and 97.0% to 91.0% and 84.0% in the retail and hospital markets.
Regression analysis showed that quarters since first biosimilar entry and number of biosimilar manufacturers were significantly associated with an increase in biosimilar market share. In the retail market, a package size offered exclusively by the reference product manufacturer was associated with a decrease in biosimilar market share, while the opposite was observed for packages offered exclusively by the biosimilar manufacturer.
In the hospital market, “neither the relative price of the biosimilar nor the relative price of the innovator was significantly associated with biosimilar market share.” In contrast, a higher relative biosimilar price was associated with a decrease in biosimilar market share in the retail market, and a higher relative originator price was associated with an increase in biosimilar market share.
Overall, the authors concluded that market share of biosimilars has improved over time across all European markets, although there is variability between member states likely due to different policy measures. They recommended policymakers work to increase competition and use countries with the highest biosimilar market diffusion rates as examples. In the retail market, they suggested biosimilar manufacturers consider offering exclusive package sizes to increase their market share.
Böhm AK, Steiner IM, Stargardt T. Market diffusion of biosimilars in off-patent biologic drug markets across Europe. Health Policy. 2023;132:104818. doi:10.1016/j.healthpol.2023.104818