Organon & Co. Samsung Bioepis Co., Ltd. that HADLIMA™ (adalimumab-bwwd), a biosimilar referencing Humira (adalimumab), is now available to patients in the United States.
Consistent with Humira, HADLIMA is available in both citrate-free high concentration (100 mg/mL) and citrate-containing low concentration (50 mg/mL) to provide patients with seamless continuity of care.
“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,” said Kevin Ali, Chief Executive Officer of Organon.
“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.”
“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,” said Christopher Hansung Ko, President and Chief Executive Officer of Samsung Bioepis.
“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,” he added.
HADLIMA is a tumor necrosis factor (TNF) blocker indicated for appropriate patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. Patients treated with adalimumab products, including HADLIMA, are at increased risk for developing serious infections that may lead to hospitalization or death. Discontinue HADLIMA if a patient develops a serious infection or sepsis.
Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HADLIMA, including the possible development of tuberculosis (TB) in patients who tested negative for latent TB infection prior to initiating therapy. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. See additional safety information below.
HADLIMA (a carton including two pre-filled pens or two pre-filled syringes) is available at a list price (wholesale acquisition cost) of $1,038, which represents an 85% discount in comparison to the list price of Humira, in order to enable expanded access to patients.
Samsung Bioepis’s adalimumab biosimilar (also known as SB5, marketed under different brand names ex-US) has been available in 24 markets globally since 2018 and is supported by extensive clinical experience across rheumatologic, dermatologic and gastroenterological conditions. SB5 has also been evaluated in more than 20 real-world studies including data from over 5,100 patients.
Autoinjector Option Recognized by the Arthritis Foundation
HADLIMA is available in both a pre-filled syringe and PushTouch autoinjector option. The autoinjector was specifically designed with the patient in mind, with a thin 29G needle, a latex-free needle cover, and a buttonless device with a sure-grip shape and a non-slip surface that is intended to fit into a patient’s lifestyle. The autoinjector has been awarded the Arthritis Foundation’s Ease of Use Certification, which recognizes products that make life easier for those living with arthritis and other functional limitations via lab and patient testing by the Intuitive Design Applied Research Institute (IDARI).1
About Organon
Organon is a global health care company formed to focus on improving the health of women throughout their lives. Organon offers more than 60 medicines and products in women’s health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon’s existing products produce strong cash flows that support investments in innovation and future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets. Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing health care that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, and endocrinology.
For more information, please visit: www.samsungbioepis.com