AbbVie’s Humira (adalimumab) is considered a first-line biologic therapy in the treatment of moderate-to-severe Crohn’s disease (CD). It had estimated CD-specific sales of $1.9bn in 2016 across the seven major healthcare markets (7MM) of the US, France, Germany, Italy, Spain, the UK, and Japan.
Humira’s rise to the top of the anti-tumour necrosis factor (anti-TNF) class is partly due to its convenient administration as a subcutaneous injection, as well as AbbVie’s extensive marketing. However, Humira is set to face competition from biosimilars in the near future, with approvals from the European Commission (EC) and US Food and Drug Administration (FDA) for Amgen’s adalimumab biosimilar Amjevita in March 2017 and September 2016, respectively. More recently, the FDA approved Boehringer Ingelheim’s Humira biosimilar Cyltezo on 25 August. How will AbbVie fare against these changing market dynamics in the CD space.
Inflammatory bowel disease refers to chronic autoimmune diseases CD and ulcerative colitis, which cause intestinal inflammation. In CD, chronic inflammation may affect any part of the gastrointestinal tract from the mouth to the anal area. CD occurs most commonly in the lower part of the small intestine and in the large intestine, although the location and severity of the disease differs by individual.
Regardless of the disease severity, corticosteroids are used to treat CD patients because they are effective in inducing disease remission. However, they are ineffective in preventing flare-ups, and the side effects associated with their long-term use mean that they cannot be used for maintenance therapy in CD.
Immunomodulators and aminosalicylates are used as first-line maintenance therapies in patients with CD of milder severity, while anti-TNF biologics such as Humira and Johnson & Johnson’s (J&J’s) Remicade (infliximab), Takeda’s anti-integrin biologic Entyvio (vedolizumab), and J&J’s interleukin 12/23 (IL-12/23) inhibitor Stelara (ustekinumab) are used in more severe patients.
AbbVie is developing IL-23 inhibitor risankizumab, which GlobalData forecasts to launch in the CD market as early as 2021 in the US and EU. Unlike the IL-12/23 inhibitor Stelara, risankizumab selectively binds to the p19 subunit that is unique to cytokine IL– 23, providing more complete inhibition of IL-23 activity.
GlobalData anticipates risankizumab will face stiff competition from Stelara as a first-in-class anti-IL therapy in the CD space, launching an estimated six years prior to risankizumab. However, based on key opinion leader insights, GlobalData forecasts risankizumab sales across the 7MM to fall closely behind Stelara, generating sales of more than $1bn by 2026.
GlobalData also forecasts Humira to generate sales of approximately $1.3bn in 2026, most notably due to the delayed launch of Humira biosimilars in the US. Following the launch of Amgen’s Humira biosimilar Amjevita, AbbVie filed a lawsuit against Amgen over various patents covering Humira’s formulation, method of use, and manufacturing process. A bench trial is scheduled to begin in early November 2019.
Although Humira’s molecule patent expired in the US in 2016, GlobalData does not expect Humira biosimilars to launch until 2023, protecting Humira from brand erosion in the largest grossing pharmaceutical market. With the potential to market two blockbuster therapies for the treatment of CD by 2026, AbbVie is well positioned to remain a CD market leader for the foreseeable future.
GlobalData (2017). PharmaPoint: Crohn’s Disease – Global Drug Forecast and Market Analysis to 2026, to be published
GlobalData (2017). PharmaPoint: Ulcerative Colitis – Global Drug Forecast and Market Analysis to 2025, January 2017, GDHC142PIDR