Humira Faces Challenge from Biosimilars and Next-Gen Therapies, Shaping the Future of AbbVie

The Crohn’s disease market in the United States is undergoing a seismic transformation, triggered by the debut of the first Humira (adalimumab) biosimilars in July. A report from data and analytics company GlobalData heralds this shift as “transformative,” signaling the beginning of the end of AbbVie’s stronghold over the patient population.

GlobalData’s crystal ball predicts that another company will dethrone the pharma giant in the Crohn’s disease (CD) market, propelled by groundbreaking advancements in biologics and oral small molecules.

Already, the second quarter of 2023 has unveiled a dramatic downturn for Humira, with sales plummeting by 25% compared to the same period in the previous year, amounting to $4 billion. The forecast for the entire year predicts a staggering 35% erosion. In response to this decline, AbbVie is placing its bets on Skyrizi, its anti-IL-23 drug, and Rinvoq, its oral JAK inhibitor, targeting patients who have failed anti-Tumor Necrosis Factor (TNF) treatments.

AbbVie had reigned as the Crohn’s market leader, boasting $2.7 billion in sales for the indication across eight major markets in the previous year, according to GlobalData. However, that dominance is rapidly fading.

Adeleke Badejo, senior analyst of immunology at GlobalData, emphasizes, “The recent launch of adalimumab biosimilars not only will cause an overall reduction in the cost of treatment but also provide the opportunity for another company to knock AbbVie from its standing as the market leader within CD.”

The competition for Humira had already intensified with Janssen’s Stelara, an IL-23 and IL-12 blocker, garnering $2.1 billion in 2022 sales in the market. Takeda’s Entyvio, which inhibits white blood cells from entering the gastrointestinal tract to reduce inflammation, captured $1.7 billion of Crohn’s sales in major markets last year.

However, as GlobalData notes, Stelara and Entyvio were typically prescribed as second- or third-line therapies following Humira or other anti-TNF biologics’ failure. Now, all three therapies face a challenging road ahead with the arrival of biosimilars, some of which are already in the market, and more in the pipeline.

Badejo observes that most companies aiming to unseat AbbVie are targeting patients who have already been exposed to biologic treatment for their disease, rather than attempting to create a next-generation replacement for Humira.

Clinical trials revealed that 36% of patients on Humira achieved and maintained remission after 56 weeks, a 4% drop from those who achieved remission at 26 weeks. This leaves a substantial portion of the Crohn’s population still in search of lasting relief from their symptoms while on the biologic.

Badejo anticipates fierce competition within the TNF-refractory patient group five to ten years down the road.

Janssen’s Tremfya is eyeing entry into the Crohn’s space, with a Phase II trial showing that 73% of adults with severe Crohn’s disease achieved clinical remission with the drug at its highest dose. Approval and launch for this indication are expected within the next two to three years.

Eli Lilly’s human monoclonal antibody Mirikizumab has already made waves in the Japanese market as the first IL-23p19 inhibitor for ulcerative colitis and is currently undergoing Phase III testing for Crohn’s.

“Innovative therapies for TNF-refractory individuals are gaining prominence, with a focus on biologic-exposed CD patients,” concludes GlobalData, signaling the dawn of a new era in Crohn’s disease treatment.

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