ORGANON & CO.
INCHEON,
'With this approval, we now have both a low and high concentration adalimumab biosimilar approved by the FDA, marking an important step towards expanding treatment options for patients suffering from certain chronic, autoimmune diseases,' said Byoungin Jung, Vice President and Regulatory Affairs Team Leader,
'Based on our success commercializing our adalimumab biosimilar in other markets around the world, combined with our established presence in the biosimilar space, we are excited about the opportunity to launch HADLIMA in the US in 2023,' said
The approval of citrate-free, high-concentration HADLIMA was based on clinical data from a randomized, single-blind, two-arm, parallel group, single-dose study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of two formulations of HADLIMA (100 mg/mL vs 50 mg/mL) in healthy volunteers.3
HADLIMA is expected to be launched on or after
About Biosimilars
A biosimilar is a biologic product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.4 Biologics are the fastest-growing class of therapeutic products in the
About HADLIMA (adalimumab-bwwd)
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 anti-rheumatic 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 adults and pediatric patients 5 years of age and older.
Limitations of Use: The effectiveness of HADLIMA has not been established in patients who have lost response to or were intolerant to 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.
About
Established in 2012,
About Organon
Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the women's health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon's products produce strong cash flows that will support investments in innovation and future growth opportunities. 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 9,300 employees with headquarters located in
For more information, visit http://www.organon.com and connect with us on Linkedin and Instagram.
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