Uptake of Biosimilars in the EU5 Blunts Share of AbbVie's Humira and Merck's Remicade in the Crohn's Disease and Ulcerative Colitis Markets, While a Black Cloud of Safety Concerns Still Follows Pfizer's Xeljanz

EXTON, Pa., July 16, 2019 /PRNewswire/ -- According to the latest report published as part of Spherix's RealTime Dynamix™: Inflammatory Bowel Disease (EU) service, EU5 gastroenterologists (n=255) report rapid uptake of adalimumab biosimilars for the treatment of both Crohn's disease and ulcerative colitis (UC), with the biosimilar brands accounting for roughly one-tenth of biologic/JAK share for each market. The same diminution can be seen for Merck's Remicade – but to a lesser extent, as infliximab biosimilars have been available for a longer period of time and brand share of this group has remained relatively stable. In both Crohn's and UC, Humira's significant losses were more than offset by adalimumab biosimilar gains; however, the same cannot be said of Remicade, as the total infliximab pie shows signs of decreased use.

Indeed, access for branded originators has worsened in the past six months as more biosimilars enter the market, with Remicade being restricted slightly more heavily than Humira.  When looking at the perceived accessibility of other agents on the market, Pfizer's Xeljanz comes in last for the treatment of UC, though this is expected due to the recent EMA approval and regional access still being finalized. This may be particularly worrisome for the JAK inhibitor brand as safety concerns, which arose in the US, have followed the agent across the pond, and a limited number of EU5 gastroenterologists were able to trial the brand prior to learning of such issues.

Xeljanz scored the EMA nod for the treatment of moderate-to-severe UC in August of 2018 with a recommended loading dose of 10mg BID for at least the first eight weeks. However, in the beginning of this year, Pfizer announced preliminary results of an ongoing post-marketing requirement study investigating the risk of cardiovascular (CV) events in patients with rheumatoid arthritis (RA). Findings indicated that patients on the 10mg BID dose of Xeljanz were statistically more likely to experience pulmonary embolism than those treated with a TNF inhibitor. Additionally, those on the 10mg twice daily dose of Xeljanz were also at an increased risk of overall mortality than those treated with a 5mg BID dose of Xeljanz or those on a TNF inhibitor.

Being a first-in-class agent for the treatment of IBD, JAK inhibitors are a newer, unknown beast, and given the approved dosing for UC is the exact one delivering significant heightened CV risk in RA, it could spell trouble among this group of already cautious practitioners. Gastroenterologists in the EU5 reported that nearly one-fifth of their UC patients are considered at high risk for venous thromboembolic events (VTE), and just about one-quarter agree that the safety news has a large negative impact on their willingness to prescribe Pfizer's drug. In the US, where Spherix has been tracking the IBD market on a quarterly basis since 2016, gastroenterologists are even more concerned, with over one-third reporting the news has a negative impact on their Xeljanz prescribing. In both regions, over three-quarters of surveyed respondents says this news will indeed influence their opinion on Xeljanz's safety.

Although safety concerns and the local access environments may be holding gastroenterologists back from prescribing Pfizer's oral JAK, the introduction of Xeljanz and additional biosimilars has resulted in a decrease of brand share for not only Humira and Remicade, but also Takeda's Entyvio. Similar to what is seen in the US, Entyvio has recorded incremental declines in both UC and Crohn's in the EU5 since Q418. However, in March, Takeda announced data from the VARSITY trial indicating that among moderate-to-severe, active UC patients, Entyvio was superior to Humira regarding the percent of patients achieving clinical remission and mucosal healing after 52 weeks of treatment.

The results of the VARSITY trial appear to have had an immediate impact on prescribing behavior in the US and the EU5; specifically, those aware of the trial in the EU5 had a 10% higher share of new Entyvio prescriptions and a 7% lower Humira share in UC, compared to those unaware. As the trial was only conducted among UC patients and physicians tend to believe Entyvio is a more efficacious option for UC than Crohn's, it is not surprising this news has yet to make a significant impact on prescribing behavior in Crohn's. With the continued decline of Humira and the palpable effects of current market events in IBD, the question will be whether adalimumab and infliximab biosimilars will maintain the TNF-dominant market or if Xeljanz's safety clouds will disperse and Entyvio's head-to-head win over Humira will make the market increasingly competitive.  

About RealTime Dynamix™
RealTime Dynamix™: Inflammatory Bowel Disease (EU) is an independent service providing strategic guidance through rapid and comprehensive twice-yearly reports, which include IBD market trending, launch tracking, and a fresh infusion of unique content with each wave. The report captures responses from ~250 EU5 (France, Italy, Germany, Spain UK) gastroenterologists. A companion service, RealTime Dynamix™: Inflammatory Bowel Disease (US), tracks the evolution of the IBD market in the US through a quarterly report series.

About Spherix Global Insights
Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance so biopharma stakeholders make decisions with confidence. We specialize in immunology, nephrology, and neurology markets.

All company, brand or product names in this document are trademarks of their respective holders.

For more information contact:
Lynn Price, Immunology Franchise Head
Email: [email protected] 
www.spherixglobalinsights.com

SOURCE Spherix Global Insights

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