December 01, 2021
Will Use of AbbVie’s Humira and Future Biosimilars in the US Inflammatory Bowel Disease Market Mirror the Current European Treatment Landscape?
By: Eric John
Biosimilars to AbbVie’s Humira (adalimumab) first hit European markets in 2018, providing physicians with a lower-cost alternative to treat patients with a number of autoimmune conditions, including inflammatory bowel disease (IBD). At the time of their introduction, gastroenterologists across the EU (France, Germany, Italy, Spain, and the UK) anticipated the biosimilars would capture one-half of branded Humira share, according to ongoing research included in Spherix’s EU RealTime Dynamix™ service.
Indeed, within six months of biosimilar availability, branded Humira share dropped eight percentage points in ulcerative colitis (UC) and nine points in Crohn’s disease (CD), while the biosimilars rocketed to a 12% share in UC and 13% share in CD.
However, while Humira share in both the UC and CD EU markets has subsequently plummeted over the last three years, adalimumab biosimilars have not fully benefitted from the continuous decline during that time. In fact, EU gastroenterologists surveyed in October 2021 reported a slight decrease in collective share of the adalimumab biosimilars in both UC and CD for the first time since their initial introduction.
When examining actual patient records of those who were previously treated with Humira and its biosimilars but recently switched to a new therapy, Spherix found that switching from both branded and biosimilar adalimumab was most commonly due to secondary efficacy issues – which in part explains the slowdown of biosimilar use when it was expected to continue soaring with the steep decline of branded Humira.
According to Spherix’s recently published 2021 audit included in their RealWorld Dynamix™: Biologic/Small Molecule Switching in IBD (EU) service, secondary efficacy failure is the number one driver of both UC and CD advanced therapy switches in the EU overall. This occurs when a patient begins to experience a reduction in efficacy after a period of time on their current treatment.
When comparing physician-reported data with patient audit data in the EU IBD market, it is evident that the two align. Data from RealWorld Dynamix™ revealed that switch-to share for the adalimumab biosimilars has leveled off in UC and slightly decreased in CD, while branded Humira has continued to decline rather rapidly in both markets.
Where is this excess brand share going to? For the first time since Spherix began tracking the IBD switching market in the EU, AMOA therapies (namely Takeda’s Entyvio, Pfizer’s Xeljanz, and Janssen’s Stelara) captured the majority of advanced therapy switch-to share. This emphasizes the importance of efficacy from more selective therapies over lower-cost TNF alternatives.
Does the current European market landscape in IBD accurately represent future implications for the US market? In Spherix’s parallel RealWorld Dynamix™ audit, capturing biologic/small molecule switching in IBD in the US, AMOA therapy uptake has already taken flight – capturing a majority of UC and CD switches.
Interestingly, unlike the EU market, the power of the AMOAs may grow exponentially before the first Humira biosimilar is even available in January 2023. With the recent approval of BMS’ S1P modulator, Zeposia, for UC and the expected 2022 approvals of AbbVie’s JAK inhibitor, Rinvoq (UC), and their IL-23 inhibitor, Skyrizi (CD), the AMOA therapies may be poised to capture more Humira share (branded and biosimilar) than previously expected and lessen the overall impact of biosimilar entry.
This blog features physician-reported data from Spherix’s RealTime Dynamix™: IBD (EU) Q4 2021 report as well as patient-level data from the 2021 audits included in RealWorld Dynamix™: Biologic/Small Molecule Switching in IBD EU and US services.
RealTime Dynamix™ 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 EU report captures responses from ~250 EU5 (France, Italy, Germany, Spain, and the UK) gastroenterologists each wave.
RealWorld Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits. Insights reveal the “why” behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists’ attitudinal & demographic data to highlight differences between stated and actual treatment patterns.