The Top 5 Most-Read Gastroenterology Articles of 2024

The top gastroenterology biosimilar stories of 2024 highlight Skyrizi surpassing Humira in sales, raising concerns over "product hopping" potentially limiting biosimilar adoption. Despite several US adalimumab biosimilar launches in 2023, uptake has been slow. Additionally, FDA and European approvals of ustekinumab biosimilar products are poised to improve access and reduce costs for patients with Crohn disease and ulcerative colitis.

Here are the top 5 gastroenterology biosimilar articles in 2024.

5. Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo

Abbvie sales records showed that Skyrizi (risankizumab-rzaa) surpassed Humira (reference adalimumab) in sales during Q3 2024, generating $3.205 billion, while Humira's revenues declined 37.2% to $2.227 billion. The shift highlighted AbbVie’s strategic pivot to newer products like Skyrizi and Rinvoq, amid increased biosimilar competition in the adalimumab market. However, concerns persist about "product hopping," which may stifle biosimilar adoption and market sustainability despite recent gains in biosimilar formulary inclusion.

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4. Happy Birthday Adalimumab Biosimilars: Reflecting on the First Year of US Competition

Since January 2023, the US adalimumab biosimilar market has grown rapidly, with 9 products launched, offering lower-cost alternatives to Humira across multiple therapeutic areas. Despite this, uptake has been slow, with biosimilars capturing just 2% of the market in their first year, reflecting challenges in provider confidence, payer preferences, and interchangeability adoption. Experts recommend increased education, transparent pricing policies, and innovative plan designs to enhance biosimilar adoption and realize potential cost savings.

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3. Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval

The FDA approved Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), marking the second ustekinumab biosimilar approval and Alvotech's second US biosimilar approval. Selarsdi is designed to treat conditions like plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis, and its development leveraged innovative manufacturing processes. With US Stelara sales reaching $6.4 billion in 2022, Selarsdi's approval is expected to enhance patient access and reduce health care costs as biosimilar competition increases.

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2. FDA Approves First Stelara Biosimilar, Wezlana

The FDA approved Wezlana (ustekinumab-auub), the first biosimilar referencing Stelara, with an interchangeability designation allowing substitution at the pharmacy level without provider approval. Wezlana demonstrated comparable safety and efficacy to Stelara in a phase 3 trial, meeting its primary endpoint in patients with moderate to severe plaque psoriasis. This approval aims to enhance access and convenience for patients, with Amgen planning a launch by January 2025 following its settlement with Stelara’s maker, Janssen.

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1. EMA Approves First Ustekinumab Biosimilar, Uzpruvo

The European Medicines Agency (EMA) approved Uzpurvo, the first Stelara biosimilar for the region, for treating Crohn disease, psoriatic arthritis, and plaque psoriasis. Developed by Alvotech and marketed by STADA Arzneimittel, Uzpurvo launched in July 2024 after Stelara's European exclusivity expired. The companies behind the biosimilar championed the approval, saying they hope it will enhance patient access to biologic therapies. The European ustekinumab market is currently valued at €2.5 billion and includes over 95,000 current users across the European Union and the UK.

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