AbbVie Unlocks Pediatric Formulation of Humira® in China to Address Unmet Needs in Children with Immune-Mediated Diseases

China is home to more than 220 million children, whose disease prevention and treatment as well as healthy growth are vital to the well-being of countless families. In this regard, the National Health Commission of China, together with five other ministries and commissions, jointly issued the “Several Opinions on Ensuring Pediatric Drug Supply,” which clearly points out that while the safeguarding of children’s health in China is gradually improving, there remains an insufficient variety of appropriate pediatric drugs, dosage forms, and strengths. Continued multi-stakeholder efforts are needed to steadily enhance the level of clinical drug supply assurance for children.

Recently, reporters learned from AbbVie, a top-10 global research-based biopharmaceutical company, that its blockbuster biologic Humira® (adalimumab injection) has officially begun supplying the Chinese market with a new citrate-free 20 mg/0.2 mL pre-filled syringe formulation specifically designed for children. This development will further support the rational clinical use of medications in pediatric autoimmune diseases, such as pediatric plaque psoriasis (pPs) and polyarticular juvenile idiopathic arthritis (pJIA), thereby promoting standardized disease management.

Publicly available data indicate that the originator fully human adalimumab, Humira®, was approved for two pediatric indications—polyarticular juvenile idiopathic arthritis (pJIA) and pediatric psoriasis (pPs)—in November last year and March this year, respectively. It is the first biologic agent approved for these indications in China and currently remains the only one with such approvals in the country.

Enhancing the Level of Rational Clinical Drug Use in Children

The pathogenesis of autoimmune diseases in children is complex, and treatment is challenging. These conditions have long-term and profound impacts on the mental health and overall quality of life of children and adolescents, highlighting the urgent need for early diagnosis, early intervention, and adherence to standardized treatment regimens. Compared with traditional therapeutic agents, biologics offer greater assurance in terms of efficacy and safety. The introduction of a pediatric formulation of Humira provides a practical new option for the treatment of immune-mediated diseases in children, thereby helping to improve the rational use of medications in pediatric clinical practice.

It has been reported that, compared with the conventional specification, the new pediatric formulation of Humira® (20 mg/0.2 mL) maintains the same active ingredient, with consistent efficacy and safety profile. The 20 mg/0.2 mL dosage form is a fixed-dose, pre-filled syringe that provides a more appropriate, smaller-dose option for children weighing less than 30 kg, offering simplicity and convenience in administration. Furthermore, this 20 mg/0.2 mL formulation is free from citrates and other excipients. Studies have demonstrated that it reduces injection pain by 84%, thereby alleviating children’s fear of needle-related pain and further improving their adherence to treatment.

Patient-Centricity: Continuous Exploration and Innovation

Since its launch in China in 2010, Humira®, one of AbbVie’s most prominent products in the immunology sector, has continuously explored and innovated to better meet patients’ treatment needs.

In 2010, Humira® pre-filled syringes (40 mg/0.8 mL) were approved in China, enabling patients to self-administer subcutaneous injections without dose adjustment. This significantly reduced the time spent on medical visits, allowing patients to better manage their daily lives and alleviating the burden on their families. In 2016, Humira® achieved stability for two weeks at room temperature, facilitating portability and use during travel or business trips, thereby freeing patients from concerns while away from home.

In 2020, the new citrate-free formulation of Humira® (40 mg/0.4 mL) and the new citrate-free formulation specifically designed for pediatric patients (20 mg/0.2 mL) became fully available in the Chinese market, once again demonstrating AbbVie’s commitment and efforts to put patients first and deliver improved treatment experiences.

Currently, Humira® has been approved for seven indications in China, including five adult indications—rheumatoid arthritis, ankylosing spondylitis, psoriasis, Crohn’s disease, and uveitis—and two pediatric indications—polyarticular juvenile idiopathic arthritis and pediatric plaque psoriasis—demonstrating a commitment to further meeting the treatment needs of more patients.

Autoimmune diseases have long constituted the second-largest therapeutic area after cancer, with a substantial unmet need for patient treatment. Beyond common conditions such as rheumatoid arthritis, ankylosing spondylitis, and psoriasis, there are more than 100 different types of autoimmune diseases for which patients urgently require effective therapeutic agents.

To this end, AbbVie is actively developing and introducing two promising next-generation therapies in this field to China: the reversible oral selective JAK inhibitor RINVOQ and the IL-23 inhibitor SKYRIZI. The company aims to continue providing innovative treatment options for Chinese patients with conditions such as atopic dermatitis, ulcerative colitis, and psoriatic arthritis, striving to advance the clinical management of these diseases and make a profound impact on patients’ lives.