The Price and Market Share Evolution of the Original Biologics and Their Biosimilars in Finland

Market Share Evolution of Biosimilars

The biosimilar uptake varied between different active substances (Table 2, Electronic Supplementary Material [ESM]). At the end of the observation period in 2020, the market shares of filgrastim and epoetin biosimilars were 100%, while the market shares of insulin glargine (6%), teriparatide (0%), and enoxaparin (6%) biosimilars were low. The biosimilar market shares for the other seven active substances were in-between.

Table 2 Summary of the uptake and utilization of biosimilars and their price differences to the reference products in Finland during the observation period from 1 January 2009 (somatropin and epoetin) or the first biosimilar market entry (other active substances) to 31 August 2020 [20,21,22,23]

The combined utilization of the reference product and its biosimilars, measured by DDDs, was the highest for insulin glargine, followed by enoxaparin, adalimumab, insulin lispro, and etanercept at the end of the observation period. The sales of the first biosimilars of these five active substances started in the first month when entering the market (Table 2). Biosimilars for other active substances that entered the market during the observation period were not sold during the first month. Six active substances had multiple biosimilars on the market during the observation period. The first biosimilar of the active substance had the largest market share by the end of the observation period, except filgrastim, whose second biosimilar had the largest market share.

Non-biosimilar competitors Toujeo® and Liprolog® had gained remarkable market shares (32% and 49%, respectively) at the end of the observation period (Table 2, ESM). After their introduction to the market, competitors’ uptakes were the same or more efficient than biosimilar uptake of the same active ingredient.

Price Evolution of Biosimilars

Seven of the first biosimilars were 26–31% lower priced than the reference product when the biosimilar was first sold (Table 2, ESM). The first biosimilar of the insulin glargine had the smallest price difference to the reference product (15%), and the first biosimilar of enoxaparin had the largest (42%). For all active substances, apart from enoxaparin, biosimilar prices either remained steady or decreased over the observation period from 1 January, 2009 (somatropin and epoetin) or the first biosimilar market entry (other active substances) to 31 August, 2020. The combined wholesale weighted average price of enoxaparin biosimilars increased by 22%.

Somatropin, insulin glargine, insulin lispro, etanercept, and teriparatide had only one biosimilar on the market during the observation period (Table 2). The prices of these biosimilars had only small changes, except the somatropin biosimilar, whose price decreased by 27% in September 2010 (ESM). Only small changes were observed in the prices of the two biosimilars of follitropin during the observation period. However, the first of two epoetin biosimilars had more price variation (ESM). The price of the epoetin first biosimilar slowly increased but began to decrease in October 2012. After that, the price has slightly decreased or stayed stable. Filgrastim, pegfilgrastim, adalimumab, and enoxaparin had more than two biosimilars on the market. The prices of the filgrastim biosimilars began to differ in 2017 when the prices of the biosimilars either stayed stable or decreased (maximum price decrease 63%). The price of the pegfilgrastim first biosimilar decreased by 14%, and the third biosimilar by 7% over the observation period. The price development of the pegfilgrastim second and fourth biosimilars is unknown because these products were not sold over the observation period, and we could not calculate the wholesale weighted average price. The prices of the first three adalimumab biosimilars decreased by 19–23%, and the fourth biosimilar price stayed stable.

For all active substances for which prices of biosimilars and reference products were known at the end of the observation period, biosimilars were more affordable than reference products. However, the insulin lispro competitor Liprolog® was sold at a lower price than the insulin lispro biosimilar.

Effect of the Biosimilar Market Entry on the Price of the Reference Product

There were only small changes in the price of the somatropin reference product after the biosimilar market entry, except at the beginning of the year 2013 (62 months after the biosimilar market entry) when the price decreased approximately 30% (ESM). The largest price decrease for the epoetin reference product was 12% in October 2009, and after that, the price has slightly increased or stayed stable. The price of the filgrastim reference product seemed to decrease 43 months after the biosimilar market entry in January and February 2013. However, after 2 years, the price increased even to a higher level than before the price decreased. At the end of the observation period, epoetin and filgrastim reference products were no longer reimbursed (Table 2).

The relative changes in the wholesale weighted average prices of the reference products were further analyzed for the eight other active substances (Fig. 1). For enoxaparin, teriparatide, insulin lispro, adalimumab, and etanercept, the price of the reference product remained fairly stable before the biosimilar entered the market. For insulin glargine, pegfilgrastim, and follitropin, the price of the reference product was higher 3 years before the biosimilar market entry compared to the price at the time of the biosimilar market entry.

Fig. 1figure 1

Development of relative prices of reference products for eight active substances. The observation period began 3 years (36 months) before the first biosimilar entered the market and continued for 3 years (36 months) thereafter. The relative prices of the reference products are standardized to be 1 when the first biosimilar entered the market (at 0 months). The price decreases for insulin glargine (− 33 months) and follitropin (− 19 months) reference products occurred in 2013

Compared to the time before biosimilars entered the market, larger changes in prices of the reference products were observed after the biosimilar market entry (Fig. 1). For all active substances, except enoxaparin and insulin lispro, the price of the reference product decreased permanently after the biosimilar entered the market. With enoxaparin, whose observation period was 8 months after biosimilar introduction, no changes in the price of the reference product were observed. The price of the insulin lispro reference product decreased at first, but after 18 months, it increased higher than at the time of biosimilar introduction. At the end of the observation period, the insulin lispro reference product was no longer in the reimbursement scheme (Table 2).

For those active substances whose biosimilars entered the market after 2017, the prices of the reference products fell shortly after the biosimilars entered the market compared with the price decreases for insulin glargine and follitropin (Fig. 1). The insulin glargine reference product price decreased in December 2016 and again in April 2017. The follitropin reference product price decreased between March and June 2017.

Model 2 was a better fit for seven reference products in the statistical analysis. Model 1 was only used for the teriparatide reference product. The changes in the price level of the reference products after the interruption (the price decrease of the reference product or biosimilar market entry) were statistically significant for six reference products (follitropin, insulin glargine, pegfilgrastim, adalimumab, teriparatide and enoxaparin) and statistically insignificant for two reference products (insulin lispro and etanercept) (Table 3). The change in the price level of the etanercept reference product after the interruption was not statistically significant, although the price drop can be seen in Fig. 1. However, without the Newey–West method [29], the change in the price level was a significant result (p < 0.001), and similarly, Model 1 yielded a statistically significant result (p < 0.001) using the Newey–West method. There were statistically significant price trends of the reference products before the interruption of the time series and statistically significant changes in the price trends of the reference products after the interruption of the time series (Table 3).

Table 3 Impact of biosimilar market entry on the reference product price (in Euros) per DDD. Active substances are listed by the date the first biosimilar entered the Finnish market. Results are presented with a 95% confidence interval, and statistically significant p values (p < 0.01) are bolded

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