US Gastroenterologists May Thwart Uptake of New Biosimilars Such as, Pfizer’s Inflectra and Merck/Samsung Bioepis’ Renflexis, by Choosing an Alternative TNF-Inhibitor, Such as AbbVie’s Humira

EXTON, Pa., Aug. 29, 2017 /PRNewswire/ -- According to the Q3 update of RealTime Dynamix™: Inflammatory Bowel Disease (IBD), US gastroenterologists (n=103) report a significant decline in the percent of their UC patients treated with Remicade (branded infliximab) since 2016.  Not only is the decline attributed to adoption of infliximab biosimilars, but use of Humira has also significantly increased, potentially indicating that more UC patients are being placed on Humira to avoid insurance mandates for infliximab biosimilar use. Over one-third of surveyed US gastroenterologists agree that that if a pharmacy or managed care plan advises them to use Inflectra over Remicade that they are more likely to choose a different TNF-inhibitor altogether.  The good news for Remicade is that only one in five gastroenterologists report having received such contact from a pharmacy or insurance provider.  Indeed, the most reported barrier to increased Inflectra use is a lack of insurance mandates to change, though as additional biosimilars become available, such as Merck/Samsung- Bioepis' Renflexis, Sandoz's Erelzi (etanercept), Amgen's Amjevita (adalimumab), and Boehringer Ingelheim's recently approved Cyltezo (adalimumab), payer pressure to switch from branded agents to their biosimilar equivalent will likely increase. 

In Crohn's disease, where non-TNF biologic options are available in the form of Takeda's Entyvio and Janssen's Stelara, pressure from biosimilars is less apparent.  Generally speaking, the Crohn's biologic landscape has remained relatively stable, with the exception of increased Stelara use.   Stelara growth in the Crohn's market is the result of increased prescriptions from existing users, among whom average patient initiations are up, but not from gaining new users. In fact, the user-base has remained consistent over the past three months.  The main impact of Stelara penetration has been halting growth of Takeda's CAM inhibitor, Entyvio.  Though current Stelara users report that is it not common for CD patients to switch from Entyvio to Stelara, Stelara is having a substantial impact on those "would be" Entyvio patients. According to surveyed gastroenterologists, the majority of current Stelara patients would have been placed on Entyvio if the IL-12/23 inhibitor were unavailable.

Gastroenterologists' future projections show big changes on the horizon for both UC and Crohn's.  In UC, infliximab biosimilars and Entyvio are poised for significant biologic share growth, while in Crohn's, infliximab biosimilars and Stelara are anticipated to experience significant gains in market share.  Of note, unlike in UC, Entyvio share in Crohn's over the next six months is projected to remain stagnant. 

Other potential market-changers are percolating in the very active IBD pipeline, with an onslaught of new oral and alternative mechanism biologics potentially right around the corner.  US gastroenterologists are familiar with the IBD pipeline and are particularly enthused about the access to oral treatments in the future.  The majority agree that there is a need for additional alternate MOA agents for the treatment of IBD and that the addition of JAK inhibitors will greatly improve their ability to efficiently treat IBD.  Pfizer's Xeljanz seems to fit the bill, and is also the next likely approval in IBD (specifically for UC), with a PDUFA action date set for March 2018.

RealTime Dynamix: IBD is an independent report series published on a quarterly basis.  The series tracks the evolution of the UC and CD markets, provides a deep dive on launch effectiveness, and highlights opportunities for pipeline agents.  The next wave of research will be fielded in October 2017.

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