Organon, Samsung Bioepis launch HUMIRA biosimilar HADLIMA in US

Organon & Co. and Samsung Bioepis revealed that HADLIMA (adalimumab-bwwd), a biosimilar referencing Humira (adalimumab), is now accessible to patients in the United States.

This development ensures a seamless continuity of care as HADLIMA is available in both citrate-free high concentration (100 mg/mL) and citrate-containing low concentration (50 mg/mL), similar to Humira.

HADLIMA, a tumor necrosis factor (TNF) blocker, caters to patients with conditions such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

As with any adalimumab products, including HADLIMA, patients must be aware of the increased risk of serious infections that may lead to hospitalization or death. Immediate discontinuation of HADLIMA is recommended if a patient develops a serious infection or sepsis.

Close monitoring for signs and symptoms of infection, including potential tuberculosis (TB) development in patients who tested negative for latent TB infection before treatment initiation, is crucial. Additionally, the use of TNF blockers, including adalimumab products, has been associated with lymphoma and other malignancies, some of which have been fatal, particularly in children and adolescent patients.

To provide expanded access to patients, HADLIMA is offered at a significantly reduced list price (wholesale acquisition cost) of $1,038, which represents an 85% discount compared to the list price of Humira.

Kevin Ali — Organon CEO said: “As the largest loss-of-exclusivity event in pharmaceutical history, this is a singular moment for the US health care system to embrace biosimilars. Every stakeholder should be invested in the success of this market to realize the value biosimilars can create for patients, providers, and the US health care economy.

“We are thrilled to now provide HADLIMA in the US at a more affordable cost and expand much-needed access to adalimumab. With our deep biosimilar commercial experience, a new comprehensive patient support program, and our dedication to providing exceptional HCP support, we are immediately well-positioned to make a positive impact.”

Samsung Bioepis’s adalimumab biosimilar, known as SB5 in global markets, has been available in 24 countries since 2018 and has garnered extensive clinical experience in treating rheumatologic, dermatologic, and gastroenterological conditions. Moreover, SB5 has undergone evaluation in more than 20 real-world studies, incorporating data from over 5,100 patients.

The availability of HADLIMA marks a significant milestone in providing affordable treatment options for patients in the US, expanding access to biosimilar therapies. With its proven efficacy and extensive clinical experience, HADLIMA holds the potential to improve outcomes and quality of life for individuals managing various chronic conditions.

Christopher Hansung Ko — Samsung Bioepis President and CEO said: “The availability of HADLIMA, both high and low concentration, marks an important milestone towards expanding treatment options for millions of patients suffering from chronic autoimmune diseases in the United States.

“Based on our robust track record over the past four years with approximately 6.8 million units of our adalimumab biosimilar supplied in ex-US markets, we are well-positioned to deliver this life-changing medicine to patients through stringent quality control, rigorous manufacturing, and supply resilience.

“Our mission is to positively impact and ensure the sustainability of health care systems by offering affordable, clinically proven biologic medicines. We will continue to work with our partners and other stakeholders to ensure wider availability of this medicine in the US.”