HUMIRA® (adalimumab) 80 mg/0.8 mL Presentation intended as an Alternative Option for Therapy Induction and Maintenance Therapy is Now Available

Maidenhead, UK, 1^st December 2018 – AbbVie a global research and development-based biopharmaceutical company, today announced the launch of HUMIRA^® (adalimumab) 80 mg/0.8 mL. The presentation is designed as an alternative option for therapy induction for approved indications (Ps, CD, HS and Uveitis, and paed CD , HS and uveitis) and convenient dosing for patients that require a dose escalation (RA, Ps, CD, and HS, andpaed CD and adol HS).

As with HUMIRA 40 mg/0.4 mL, which AbbVie introduced in 2016, the citrate buffer and other inactive ingredients have been removed and the formulation concentration increased allowing a reduction in injection volume by half. The formulation contains the same active ingredient, adalimumab and the efficacy and safety profile remains unchanged.¹ A new presentation of HUMIRA 80 mg/0.8 mL is now available in England.

"The launch of the HUMIRA 80 mg/0.8 mL formulation underscores our ongoing dedication to improving the patient experience through research and product enhancements,” said Alice Butler, Medical Director, AbbVie. “We remain committed to innovation in immunology and continue to strive to improve upon the therapeutic experience for patients and physicians.”

Use of this presentation decreases the number of injections necessary by half, for the induction doses in the approved indications.¹ In addition for patients that require a dose escalation to 40 mg weekly the availability of an 80 mg presentation allows patients to maintain their usual “every other week” dosing schedule.

Both HUMIRA 40 mg/0.4 ml and HUMIRA 80 mg/0.8 mL contain the same active ingredient, adalimumab, meaning that the efficacy and safety profile remains unchanged.¹

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Notes to editors

About HUMIRA® (adalimumab)

For further information, and recommended dosing of HUMIRA for each paediatric indication, please see the Summary of Product Characteristics: http://www.medicines.org.uk/emc.

Important EU Safety Information

HUMIRA is contraindicated in patients with active tuberculosis or other severe infections such as sepsis, and opportunistic infections and in patients with moderate to severe heart failure (NYHA class III/IV). It is also contraindicated in patients hypersensitive to the active substance or to any of the excipients. The use of HUMIRA increases the risk of developing serious infections which may, in rare cases, be life threatening. Rare cases of lymphoma and leukemia have been reported in patients treated with HUMIRA. On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death. A risk for the development of malignancies in patients treated with TNF-antagonists cannot be excluded. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.