Alternate Mechanism Biologics And Adalimumab Biosimilar Prescribing Increases At The Expense of AbbVie's Humira In The EU5 Inflammatory Bowel Disease Market, Despite The Significant Impact Of COVID-19 On Gastroenterology Practitioners

Use of alternative mechanism of action therapies, Janssen's Stelara and Takeda's Entyvio, along with adalimumab biosimilars, has increased in the EU5 since last year in ulcerative colitis and Crohn's disease, according to a recently published study by Spherix Global Insights

Exton, PA /PRNewswire/ -- According to the latest report published as part of Spherix's RealTime Dynamix™: Inflammatory Bowel Disease (EU) service, EU5 gastroenterologists (n=255) report notable gains in their prescribing of alternative mechanism of action (AMOA) agents, such as Janssen's Stelara and Takeda's Entyvio, for ulcerative colitis (UC) and Crohn's disease (CD). Both therapies have experienced growth in prescribing in the US and EU markets over the past year, as gastroenterologists migrate away from traditional anti-TNF therapy use.

Specifically, Stelara's UC share has doubled since its European Commission approval in Q3 2019, and the expansion also appears to have positively influenced share of the IL-12/23 inhibitor in CD (which has increased by 20% over the same timeframe). In the latest report, Stelara was well positioned against Entyvio based on its performance in efficacy and mode of administration, but the latter advantage is likely to change with the recently announced approval of the subcutaneous (SC) formulation for Takeda's agent in the EU in May 2020.

Early indications from the Spherix report suggest the approval of the formulation extension in the EU will only enhance physicians' receptivity to Entyvio in both UC and CD. Spherix will closely monitor the launch of Entyvio SC in the EU over the second half of 2020 and will also track the US launch in a parallel service, should the FDA approve the product extension. Indeed, Entyvio SC received a complete response letter from the FDA in late 2019, but Takeda reports that they are in ongoing discussions with the agency about a resubmission for the subcutaneous formulation by the end of 2020.

However, Entyvio doesn't need to solely rely on the new formulation for success. EU5 gastroenterologists report that Entyvio continues to have a perceived safety advantage over several other competitors (including Stelara), which is likely a large contributing force to reported higher satisfaction with Entyvio for use in UC than its closest competitor, Stelara. As such, Takeda will be tasked with building on that momentum with appropriate targeting and messaging in the very challenging COVID-19 environment.

Not to be outdone by the AMOAs in terms of EU growth in UC and CD, adalimumab biosimilars have continued their rise in prescribing over the past year, mostly at the expense of AbbVie's Humira and infliximab biosimilars. Though the rate of growth has slowed slightly since 2019, a significant majority of EU gastroenterologists expect their adalimumab biosimilar prescribing to further increase in the future. Physicians report that the bulk of their biosimilar prescribing for UC and CD occurs as a new start versus any type of switching from a branded TNF to a biosimilar counterpart. The profile of physicians who are more likely to prescribe biosimilars as switching behavior versus a new start was also analyzed as part of the biosimilar prescribing focus. The analysis revealed these physicians are more likely to be academic hospital-based and see branded sales representatives more often, explaining why they prescribed the commercial agent before switching to a biosimilar.

While the AMOAs and adalimumab biosimilars experience growth in the EU, use of AbbVie's Humira in both UC and CD is significantly down over last year. Superior access of the biosimilars and perceived better performance of the AMOAs are primarily responsible for that change.

With regard to Pfizer's Xeljanz, EU5 share did not measurably change since last year, however, a segment of steady prescribers seems to be emerging. Specifically, the average number of Xeljanz patients per prescriber has more than doubled since the prior wave, while the percentage of physicians who prescribe Xeljanz in UC has increased only slightly. Xeljanz is the only oral advanced systemic therapy available for UC in the EU, but the brand is still battling safety concerns related to elevated clotting risks that were identified in 2019. Greater physician familiarity and increased prescribing in third line is what may be driving a segment of EU gastroenterologists to have more Xeljanz patients.

Reported IBD market changes occurred despite the underlying impact of COVID-19 on gastroenterology treatment. The perceived, relative success of Germany in managing the outbreak of COVID-19 is reflected in the latest Spherix study results, as significantly less physicians from that country report a high impact of COVID-19 on their practice compared to other nations in the EU5. When asked about various aspects of the shifting dynamics of COVID-19 on their UC and CD practice, EU5 gastroenterologists across the board strongly agreed that the use of telemedicine will be with their practice well into the future.

With an evolving pipeline for both UC and Crohn's, the EU5 IBD market looks to become even more competitive in the months to come. A significant market change is expected with the potential approval of at least one of several unique oral agents in development, such as selective JAK-1 inhibitors (AbbVie's upadacitinib, Gilead's filgotinib), and S1P inhibitors (BMS' ozanimod and Arena's etrasimod).

Furthermore, there are several next generation biologics that are working towards an arguably more targeted approach and thus improvement over the existing Entyvio and Stelara brands, including, but not limited to, Roche/Genentech's MAdCAM inhibitor, etrolizumab, and IL-23 inhibitors (AbbVie's risankizumab, Eli Lilly's mirikizumab, and Janssen's guselkumab). With the advancement of these agents in development, Spherix experts anticipate substantial changes on the IBD treatment horizon.

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 The Special Report
Spherix will continue to monitor the impact of COVID-19 on gastroenterology practices in the EU in the Q4 report scheduled for release by the end of November 2020. Spherix is also reporting on the impact of COVID-19 in the US with Special Report: Multi-Specialty Impact of COVID-19 (US), an ongoing series of monthly monitoring that evaluates the impact of COVID-19 on physicians and their practices at a more in-depth level.

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 select immunology, nephrology, and neurology markets.

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