Exton, Pennsylvania, Nov. 13, 2023 (GLOBE NEWSWIRE) -- In the past two months, the landscape of available treatments for ulcerative colitis (UC) has undergone a significant expansion, marked by the approval of four new options. This includes the groundbreaking introduction of Lilly's Omvoh (mirikizumab), the inaugural IL-23 inhibitor for UC, Pfizer's Velsipity (etrasimod), a second Sphingosine-1 phosphate (S1P) receptor–modulator, and two subcutaneous formulations of established favorites: Takeda's Entyvio (vedolizumab) and Celltrion's Zymfentra for infliximab. These additions come amidst an already bustling market, teeming with both branded and increasingly competitive biosimilar alternatives.
In a scenario absent these recent launches, data from Spherix Global Insights’ RealTime Dynamix™: Ulcerative Colitis service found prescribers anticipating a relatively stable next six months, attenuated modestly by continuing adoption of new adalimumab biosimilars eroding Humira, and notable market share gains for AbbVie's Rinvoq. However, the influx of innovative agents suggests that upcoming changes are poised to be more substantial and transformative.
Insights gleaned from the Q3 update, incorporating feedback from 101 US gastroenterologists, indicate heightened anticipation for the Entyvio line-extension in comparison to the other recent approvals. This extension enjoys the highest pre-launch familiarity and generates significantly higher interest in gaining approval. Notably, when gastroenterologists were asked about their overall interest in near term approvals, more than half expressed a high level for subcutaneous (SC) Entyvio, followed by approximately one-third for Velsipity and Omvoh, and minimal interest registered for Zymfentra.
Although prescribers display significant enthusiasm for Entyvio SC, its anticipated impact on the broader market is projected to be modest. A strong majority, over eight out of ten gastroenterologists, express their intent to prescribe within the initial six months post-launch, envisioning a considerable portion of their patients making the transition to this new formulation. It's noteworthy that this expected adoption largely involves individuals currently utilizing the IV formulation. Consequently, the overall impact on Entyvio's market share is expected to be marginal, constraining the broader market influence of the SC launch.
Eli Lilly’s Omvoh may prove to have broader market implications, as a first-in-class IL-23 approval. Notably, half of specialists agree that they will have success using IL-23 inhibitors in patients who have failed or become resistant to Janssen’s Stelara, whose IL-12/23 mechanism of action (MOA) is similar to that of Omvoh’s. Furthermore, a sizeable subset of respondents agrees the targeted IL-23 MOA is more efficacious and safer than the IL-12/23 MOA. Pre-launch metrics for the Lilly drug depict a majority of specialists intending to initiate trials within six months of its launch, with a substantial pool of potential candidates. However, unaided insights from over two-thirds of respondents specify that Omvoh candidates are more likely to be those on their second- or later-line of advanced treatment. Projections for the six-month brand share are impressive, predominantly impacting the use of the anti-TNF class, although Stelara is expected to experience a small yet statistically significant decrease as well.
The UC market now has several oral agents that are likely to add to the overall disruption, including Pfizer’s Velsipity, which joins the ranks alongside Xeljanz (JAK inhibitor), BMS’ Zeposia (S1P inhibitor), and AbbVie’s Rinvoq (JAK inhibitor)—the latter being a particularly formidable force in the current market. The emergence of oral agents introduces the potential to delay the adoption of traditional biologics, as a consensus among practitioners suggests that persuading UC patients to initiate oral therapy is more palatable than introducing an injected therapy. Moreover, a substantial portion agrees that, in the treatment of UC, it is acceptable to initiate patients on safer oral therapies, even if slightly less effective, compared to biologic alternatives.
With a focus on Velsipity, the newest oral entrant garners a majority of gastroenterologists’ intentions to prescribe within the first six months of availability, showing candidacy rates of one-in-five UC patients. Projections for the six-month market share of Velsipity indicate it directly aligns with that of its in-class competitor, Zeposia. Intriguingly, it appears to have no discernible impact on the trajectory of the BMS pill. Despite prevailing sentiments favoring oral therapies in the pre-biologic treatment space, over half of respondents, unprompted, identify the ideal Velsipity candidate as someone on their second- or-later advanced systemic treatment.
Spherix will be tracking the first 18 months of Entyvio SC, Velsipity and Omvoh through its Launch Dynamix™ series, providing monthly updates on key performance indicators, benchmarked against other key IBD analogue launches. The service for Velsipity and Omvoh will also include quarterly deep dive reports including qualitative and quantitative analyses, which will capture critical perspectives from prescribers. The overall market, including impact of these entrants, will continuously be monitored via the RealTime Dynamix™ service.
RealTime Dynamix™ is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts.
Launch Dynamix™ is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand.
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