Global Data Show Variety in Adalimumab Biosimilar Design, Patient Support Systems

Not all adalimumab biosimilars are created equal when it comes to formulation design, injection devices, and patient support services—differences that may affect comfort, adherence, and access for individuals using these therapies around the world, according to a new international analysis.1

The findings, published in Therapeutic Advances in Gastroenterology, compared adalimumab biosimilars and the originator Humira across 9 countries. The authors said the goal was to help prescribers navigate a growing number of products that are clinically comparable but differ in nonpharmacologic features that can shape patient experience.

Patent Expirations Drive Rapid Market Expansion

Humira, a fully human monoclonal antibody that inhibits tumor necrosis factor (TNF)–α, was first approved by the FDA in 2002 for rheumatoid arthritis and later for Crohn disease and ulcerative colitis. Global patents for the product began expiring in 2018 in Europe and Australia and in 2023 in the US, paving the way for what experts hoped would be a surge in biosimilar competition.2

The research team gathered information from global medication registries and regulatory agencies, including the FDA, European Medicines Agency, and Health Canada, as well as authorities in Australia, India, Singapore, and the UK.1 Data were supplemented with responses from pharmaceutical manufacturers and expert insights from gastroenterologists in each participating country.

By late 2024, more than 20 adalimumab biosimilars had entered markets worldwide. The study examined 14 products in detail: 13 biosimilars and the originator Humira. Data collection concluded in September 2024, with analysis focusing on device characteristics, formulation type, and the breadth of available patient support systems.

While all products share comparable efficacy and safety with the originator, the authors noted that subtle distinctions—such as excipient composition, device usability, and availability of patient support—may meaningfully impact patient satisfaction and persistence on therapy.

Key Product Differences Identified

In total, 29 adalimumab products were identified worldwide, though many were marketed only in limited regions or lacked publicly available information. Among the 14 analyzed in depth, the authors reported notable variation in device and formulation features.

All products were available as either prefilled syringes (PFS) or auto-injectable pens (AIPs), with AIPs incorporating retractable needles to reduce needlestick risk. Most devices used 29-gauge needles, although Amgevita and Cyltezo prefilled syringes used slightly larger 27-gauge needles.

Injection mechanisms also differed: some pens delivered the drug in 2 steps, while others required a third button-press step, which could affect usability for individuals with limited dexterity.

Concentration and excipient profiles varied across brands. Several newer biosimilars—such as Yuflyma, Hukyndra, and Cyltezo—offered high-concentration (100 mg/mL), citrate-free formulations that may reduce injection volume and site discomfort. Older products, including Humira and Hadlima, retained citrate in small amounts.

Shelf life and storage flexibility also distinguished products. Imraldi offered the longest refrigerated shelf life (42 months), while Yuflyma, Abrilada, Hukyndra, and Xelenka could be stored at room temperature for up to 30 days. Humira and several others lasted only 14 days outside refrigeration. All reviewed products were latex-free except for certain versions of Cyltezo and Amgevita.

Stronger Patient Support Programs in Australia, Canada, and the US

Patient support program (PSP) availability differed significantly between countries. Programs in Australia, Canada, and the United States were the most comprehensive, often providing 1-on-1 injection training, educational videos, help hotlines, and adherence reminders.

Some manufacturers also offered additional resources. In Australia, for example, Idacio patients could access online cognitive behavioral therapy modules, and Humira users were eligible for personalized health coaching calls covering nutrition or lifestyle goals. Amgevita and Hadlima offered both digital reminders and refill notifications, while all major products in Australia provided sharps containers and travel packs.

In contrast, PSPs in India, Japan, and Portugal were less standardized and sometimes limited to online informational portals or printed materials. The authors noted that these disparities may affect how confident and supported individuals feel when starting biologic therapy.

Data Gaps and Limitations

The investigators acknowledged that not all manufacturers responded to data requests, particularly those marketing products exclusively in India and other emerging markets. Additionally, the analysis focused on product attributes and support programs rather than clinical or adherence outcomes, limiting conclusions about how these features affect real-world use.

The study’s authors emphasized that although all adalimumab biosimilars are designed to be therapeutically equivalent, their practical differences matter. Formulation concentration, injection ease, storage requirements, and patient education resources can influence both provider preference and patient adherence.

“Adalimumab biosimilars have various strengths and weaknesses, and no single product is perfect for every patient,” the researchers wrote. “It’s important to choose a product that fits each patient’s individual needs and healthcare situation.”

As biosimilar competition continues to expand globally, the combination of usability, convenience, and patient support may become an increasingly important differentiator in long-term adoption.

References

1. Yiu TH, Anderson E, Leung WK, et al. Adalimumab around the world: comparative analysis of products characteristics and patient support systems. Therap Adv Gastroenterol. Published online October 5, 2025. doi:10.1177/17562848251358168

2. Jeremias S. Happy birthday adalimumab biosimilars: reflecting on the first year of US competition. The Center for Biosimilars®. January 31, 2024. Accessed November 5, 2025. https://www.centerforbiosimilars.com/view/happy-birthday-adalimumab-biosimilars-reflecting-on-the-first-year-of-us-competition