Crohn’s Disease and Ulcerative Colitis (Market Access Landscape) | Physician & Payer Forum | EU5 | 2015

Payer and Physician Perspectives on the Role of New Biologics and Biosimilars for Moderate to Severe Inflammatory Bowel Disease

Moderate to severe inflammatory bowel disease (IBD) patients who fail to respond to conventional treatments, such as aminosalicylates, corticosteroids, and immunosuppressants, are commonly treated with biologic therapies. Until recently, TNF-alpha inhibitors Remicade (infliximab; Merck) and Humira (adalimumab; AbbVie) were the only biologics approved for Crohn’s disease (CD) and ulcerative colitis (UC) in Europe. Another, Simponi (Merck), was approved by the EMA for UC in 2013. In 2014, a CAM inhibitor, Entyvio (vedolizumab; Takeda), became the first non-TNF-alpha biologic granted European marketing authorization for CD and UC. The first biosimilars in the IBD field, Inflectra (infliximab; Hospira) and Remsima (infliximab; Celtrion), received marketing authorization from the EMA in 2013 and were subsequently launched in EU5 countries in the beginning of 2015. Despite the recent launches, Remicade and Humira still dominate the EU5 IBD market. However, the dynamics of this high-priced market are about to change with the introduction of the less expensive biosimilar versions of infliximab and adalimumab (launch expected 2018). In addition, new biologics Stelara (Janssen) for CD and Xeljanz (Pfizer) for UC are expected to become approved in Europe in 2016.

This report analyzes European physicians’ and payers’ attitudes with respect to the changing CD/UC market through year-end 2018. We focus on physicians’ and payers’ view of the marketed TNF-alpha inhibitors; recently launched Entyvio, infliximab, and adalimumab biosimilars, and emerging therapies Stelara and Xeljanz.