Very little is comparable between the US and Europe in terms of biosimilar approval, launch, and market penetration, but the latest data from Ronny Gal, PhD and his team at Bernstein Research make it possible to do a snapshot review of the two major markets. The statistics paint an encouraging picture of increasing biosimilar penetration in most categories.
In Europe, biosimilar uptake of major reference products far outpaces that in the US. For example, filgrastim biosimilars have a 94% market penetration overall in Europe through January 2020, according to Bernstein’s global report (compared with 72% in the US). That remains the top penetration of any biosimilar agent. In second place are the biosimilars of epoetin at 83%. These two leaders have been available the longest of the major biosimilar products (since 2008) in Europe.
There are stark differences between the EU and US, and these are not just for agents that have yet to launch in the US (e.g., etanercept and adalimumab biosimilars). Both infliximab and rituximab agents have done exceedingly well in the EU, capturing 71% shares, whereas the US share for infliximab biosimilars are still only at 15% since Inflectra®’s introduction in late 2016. Rituximab biosimilars have only been available in the US since October 2019, and uptake has been slower. It should be noted that the market penetrations for both infliximab and rituximab in Europe are still rising.
In the US, marketshares of pegfilgrastim, trastuzumab, and bevacizumab biosimilars are climbing fast. In Europe, Neulasta® biosimilars have attained 42% of the market, compared with 29% in the US, in approximately the same period of time since launch. Interestingly, market share of Neulasta OnPro® in the US has remained steady at 54%, so nearly all of the biosimilar gains here have come at the expense of the prefilled syringe forms. Bernstein’s report noted that because of the COVID-19 pandemic, OnPro’s marketshare may increase, owing to the national recommendations to shelter in place and reduce physician office visits when possible. The report recorded minimal marketshare for Sandoz’s Ziextenzo®, which had only been marketed in the US since November 2019.
In the case of bevacizumab, the principal drug patents won’t expire until 2022 in Europe, as opposed to 2019 in the US, and so Mvasi® and Zirabev®, both approved in the EU, have not yet launched there.
TABLE: BIOSIMILAR UPTAKE IN THE EU* AND THE US (as of 1/2020)
Data from IQVIA and Bernstein Research analysis.
According to the Dr. Gal’s group, the uptake of late-to-market entrants is consistently challenging. This may have important implications for the US adalimumab marketplace once it opens in 2023 and for etanercept biosimilars, if they become available very soon (and not in 2029, per patent litigation).
The exception to this finding is Coherus’ introduction of Udenyca® (pegfilgrastim). In fact, at a presentation this week at the Academy of Managed Care Pharmacy’s E-Learning Days, Doug Long, characterized Coherus’ launch as one of the “most successful” of 2019.