- Adalimumab-aaty will be priced at an 85% discount to HUMIRA® (adalimumab)
- Branded and unbranded versions of Celltrion USA’s adalimumab biosimilar help provide more affordable options for patients
JERSEY CITY, NJ, USA I May 9, 2024 I Celltrion USA announced today that adalimumab-aaty, the company’s high-concentration (100 mg/mL) and citrate-free formulation biosimilar to HUMIRA ® (adalimumab), is now available at a low wholesale acquisition cost (WAC). Adalimumab-aaty will be priced as WAC list price at an 85% discount to the current WAC list price of HUMIRA. Adalimumab-aaty is also available from Celltrion USA under the brand name YUFLYMA®, which launched in July 2023 and is available at a 5% discount to the current WAC list price of HUMIRA.
Adalimumab-aaty is approved for the treatment of eight conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.
“Access to medications in the U.S. has become increasingly complex, and there is so much value that biosimilars add with competition in the marketplace,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. “The availability of branded and unbranded versions of adalimumab-aaty will improve the accessibility of adalimumab biosimilars in the U.S., providing economic benefits for patients and the overall healthcare system.”
Adalimumab-aaty is available as 40 mg/0.4mL, 80 mg/0.8mL and 20 mg/0.2mL.
INDICATIONS
Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for:
- Rheumatoid Arthritis (RA): 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 RA
- Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older
- Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA
- Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS
- Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older
- Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults
- Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers
- Plaque Psoriasis (Ps): 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
- Hidradenitis Suppurativa (HS): treatment of adult patients with moderate to severe hidradenitis suppurativa
Please see full Prescribing Information including Boxed Warning for adalimumab-aaty
About adalimumab-aaty[1]
Adalimumab-aaty is an unbranded version of YUFLYMA® (CT-P17, biosimilar adalimumab). YUFLYMA is a recombinant fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody. YUFLYMA is FDA-approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and Hidradenitis Suppurativa. Following the launch of 40mg/0.4mL in July 2023 and 80mg/0.8mL in December 2023, additional dosage form of 20mg/0.2mL was launched in the U.S. in March 2024.
About Celltrion USA
Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has five biosimilars approved by the U.S. FDA: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd) and YUFLYMA®(adalimumab-aaty) as well as a new biologic ZYMFENTRA™. Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit: www.celltrionusa.com/
References
[1] Adalimumab-aaty U.S. prescribing information
SOURCE: Celltrion USA
Post Views: 1,467
- Adalimumab-aaty will be priced at an 85% discount to HUMIRA® (adalimumab)
- Branded and unbranded versions of Celltrion USA’s adalimumab biosimilar help provide more affordable options for patients
JERSEY CITY, NJ, USA I May 9, 2024 I Celltrion USA announced today that adalimumab-aaty, the company’s high-concentration (100 mg/mL) and citrate-free formulation biosimilar to HUMIRA ® (adalimumab), is now available at a low wholesale acquisition cost (WAC). Adalimumab-aaty will be priced as WAC list price at an 85% discount to the current WAC list price of HUMIRA. Adalimumab-aaty is also available from Celltrion USA under the brand name YUFLYMA®, which launched in July 2023 and is available at a 5% discount to the current WAC list price of HUMIRA.
Adalimumab-aaty is approved for the treatment of eight conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.
“Access to medications in the U.S. has become increasingly complex, and there is so much value that biosimilars add with competition in the marketplace,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. “The availability of branded and unbranded versions of adalimumab-aaty will improve the accessibility of adalimumab biosimilars in the U.S., providing economic benefits for patients and the overall healthcare system.”
Adalimumab-aaty is available as 40 mg/0.4mL, 80 mg/0.8mL and 20 mg/0.2mL.
INDICATIONS
Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for:
- Rheumatoid Arthritis (RA): 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 RA
- Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older
- Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA
- Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS
- Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older
- Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults
- Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers
- Plaque Psoriasis (Ps): 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
- Hidradenitis Suppurativa (HS): treatment of adult patients with moderate to severe hidradenitis suppurativa
Please see full Prescribing Information including Boxed Warning for adalimumab-aaty
About adalimumab-aaty[1]
Adalimumab-aaty is an unbranded version of YUFLYMA® (CT-P17, biosimilar adalimumab). YUFLYMA is a recombinant fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody. YUFLYMA is FDA-approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and Hidradenitis Suppurativa. Following the launch of 40mg/0.4mL in July 2023 and 80mg/0.8mL in December 2023, additional dosage form of 20mg/0.2mL was launched in the U.S. in March 2024.
About Celltrion USA
Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has five biosimilars approved by the U.S. FDA: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd) and YUFLYMA®(adalimumab-aaty) as well as a new biologic ZYMFENTRA™. Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit: www.celltrionusa.com/
References
[1] Adalimumab-aaty U.S. prescribing information
SOURCE: Celltrion USA
Post Views: 1,467
