HADLIMA is an FDA-approved biosimilar to HUMIRA for the treatment of specific autoimmune or autoinflammatory conditions such as rheumatoid arthritis, Crohn's disease, hidradenitis suppurativa, and plaque psoriasis.
'America's veterans deserve access to quality medicines at a lower cost. We are proud to support the more than nine million people enrolled in the
HADLIMA was launched in the US to offer patients a more affordable option without compromising on safety and efficacy. HADLIMA is FDA approved in both citrate-free high concentration (40 mg/0.4 mL), the most-utilized formulation of the originator, and citrate-containing low concentration (40 mg/0.8 mL) formulations to provide patients with continuity of care. Intended to fit into a patient's lifestyle, HADLIMA is available in both a pre-filled syringe and autoinjector option. The HADLIMATM PushTouch 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. The PushTouch Autoinjector has been awarded the
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.
About HADLIMA (adalimumab-bwwd) Injection, 40 mg/0.4 mL and 40 mg/0.8 mL
HADLIMA is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis: HADLIMA is indicated, alone or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs), for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
Juvenile Idiopathic Arthritis: HADLIMA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
Psoriatic Arthritis: HADLIMA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
Ankylosing Spondylitis: HADLIMA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
Crohn's Disease: HADLIMA is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older.
Ulcerative Colitis: HADLIMA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.
Limitations of Use
The effectiveness of HADLIMA has not been established in patients who have lost response to or were intolerant to tumor necrosis factor (TNF) blockers.
Plaque Psoriasis: HADLIMA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HADLIMA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
Hidradenitis Suppurativa: HADLIMA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients.
Uveitis: HADLIMA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
About Organon
Organon is a global healthcare 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
Cautionary Note Regarding Forward-Looking Statements
Some statements and disclosures in this press release are 'forward-looking statements' within the meaning of the safe harbor provisions of the
Risks and uncertainties that may affect Organon's future results include, but are not limited to, an inability to fully execute on the product development and commercialization plans for HADLIMA in
Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon's filings with the
Contact:
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