On 13 December 2017, Pfizer announced that the FDA had granted approval for Ixifi (Remicade biosimilar) for the treatment of multiple chronic inflammatory diseases such as ulcerative colitis (UC). Ixifi is Pfizer’s second Remicade biosimilar that has been approved in the US, as Pfizer markets Celltrion’s Inflectra (Remicade biosimilar) in the US.

Pfizer now faces the task of strategically marketing Ixifi and Inflectra to compete with Remicade (infliximab) and other approved Remicade biosimilars, including Biogen/Samsung Bioepis’ Renflexis, in the UC space. That being said, the approval of Pfizer’s second Remicade biosimilar marks a win for the company in the UC space, with the potential to steal substantial market share from Remicade.

UC is a chronic inflammatory disease of the colon or large intestine that usually initially manifests in the terminal part of the colon (rectum) and extends either to the left part of the colon or to the entire colon as the disease progresses. In 2015, there were over 601,000 diagnosed prevalent cases of moderate to severe UC globally across all ages.

Driving down costs with biosimilars

When patients fail to respond to conventional therapies, physicians prescribe biologics; these include tumor necrosis factor (TNF) alpha inhibitors – including Johnson & Johnson’s (J&J’s) Remicade, AbbVie’s Humira (adalimumab), and J&J’s Simponi (golimumab) – and Takeda’s anti-integrin therapy, Entyvio (vedolizumab). Biologics offer an attractive alternative to conventional therapies, as these medications can help to both induce and maintain remission.

Key opinion leaders (KOLs) interviewed by GlobalData suggest that Remicade is the preferred TNF alpha inhibitor to use for moderate to severe UC patients, and in 2017 it generated a staggering $1.24bn globally in the UC market according to GlobalData forecasts, which is more than any other drug in the space.

KOLs noted that the cost of using TNF alpha inhibitors is high and believe that the introduction of more cost-effective biosimilars is needed in the market to drive down the prices of these therapies. US KOLs also suggested that physicians are more likely to prescribe biosimilar products following the results of the NOR-SWITCH study, which demonstrated that Inflectra is safe and efficacious and has similar operating characteristics to the originator molecule.

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GlobalData forecasts that Remicade will suffer from biosimilar erosion as Remicade biosimilars will generate global revenue of $609m in UC by 2025, at a compound annual growth rate of 29.7%. With the approval of Ixifi and the increased reputation of Inflectra, it is likely that Pfizer will hold a significant share of the revenue from biosimilar erosion of Remicade in UC.

However, KOLs interviewed by GlobalData believe third-party payers in the US will not switch patients to the biosimilar unless offered a reasonable discount; therefore, it is imperative that Pfizer prices the drug competitively not only to Remicade, but to other marketed Remicade biosimilars.

Related Reports

GlobalData (2017). PharmaPoint: Ulcerative Colitis – Global Drug Forecast and Market Analysis to 2025, January 2017, GDHC142PIDR

GlobalData (2017). PharmaPoint: Crohn’s Disease – Global Drug Forecast and Market Analysis to 2026, to be published