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Celltrion USA’s adalimumab-aaty biosimilar to HUMIRA® now available at low wholesale acquisition cost

JERSEY CITY, N.J., May 10, 2024 /PRNewswire/ — 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.

IMPORTANT SAFETY INFORMATION[1]
This important safety information also applies to YUFLYMA
® (adalimumab-aaty)

SERIOUS INFECTIONS

Patients treated with adalimumab-aaty are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue adalimumab-aaty if a patient develops a serious infection or sepsis.

Reported infections include:

Carefully consider the risks and benefits of treatment with adalimumab-aaty prior to initiating therapy in patients with chronic or recurrent infection.

Monitor patients closely for the development of signs and symptoms of infection during and after treatment with adalimumab-aaty, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to the use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.

HYPERSENSITIVITY

HEPATITIS B VIRUS REACTIVATION

NEUROLOGIC REACTIONS

HEMATOLOGIC REACTIONS

HEART FAILURE

AUTOIMMUNITY

IMMUNIZATIONS

ADVERSE REACTIONS

INDICATIONS

Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for:

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/

FORWARD-LOOKING STATEMENT

Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion that may constitute forward-looking statements, under pertinent securities laws.

These statements may be identified by words such as “prepares,” “hopes to,” “upcoming,” “plans to,” “aims to,” “to be launched,” “is preparing,” “once gained,” “could,” “with the aim of,” “may,” “once identified,” “will,” “working towards,” “is due,” “become available,” “has potential to,” the negative of these words or such other variations thereon or comparable terminology.

In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion’s management, of which many are beyond its control.

Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions with respect to the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.

Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements.

Such Risks and uncertainties may include, among other things, uncertainties regarding the launch timing and commercial success of Celltrion in the United States; the uncertainties inherent in supply chain, manufacturing, research and development, and the possibility of unfavorable new clinical data and further analyses of existing clinical data as it relates to Celltrion products; intellectual property and/or litigation/settlement implications; decisions by the FDA impacting labeling, manufacturing processes, safety, promotion, and/or other matters that could affect the availability or commercial potential of Celltrion products; and uncertainties regarding access challenges for our biosimilar products where our product may not receive appropriate formulary access or remains in a disadvantaged position relative to competitive products; and competitive developments. A further description of risks and uncertainties can be found in Celltrion’s Annual Report.

Although forward-looking statements contained in this presentation are based upon what management of Celltrion believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

Trademarks
HUMIRA® is a registered trademark of AbbVie Biotechnology Ltd.
YUFLYMA® is a registered trademark of Celltrion, Inc., used under license.

References

[1] Adalimumab-aaty U.S. prescribing information

US-YUF-24-00007 04/24

Contacts
Sarah Amundsen
samundsen@apcoworldwide.com
+1 920-946-0918

 

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