Celltrion USA Announces Launch Of Additional Doses For YUFLYMA (adalimumab-aaty) In The U.S

Celltrion USA announced today the launch of an 80mg dose of YUFLYMA (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of HUMIRA (adalimumab) biosimilar, in the United States.

YUFLYMA is currently available in a single 40 mg dose in both a prefilled syringe with safety guard and autoinjector. The addition of an 80 mg dose will offer more choice and dosage flexibility for patients and clinical practices. YUFLYMA 80 mg is offered at the same price as YUFLYMA 40 mg to meet the needs of patients, prescribers, and payers. In addition, a 20 mg dose of YUFLYMA is expected to be available in pharmacies in late Q1 2024.

More than 80% of patients treated with HUMIRA in the U.S. rely on a high-concentration and citrate-free formulation.^[1] YUFLYMA is a citrate-free formulation that is highly concentrated at 100mg/mL. It also maintains stability at 25℃ (77°F) for 31 days, with protection from light, and is a latex-free device.^[2]

“YUFLYMA demonstrated a comparable efficacy, safety, pharmacokinetics, and immunogenicity profile as the reference product,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. “These new dose amounts and the auto-injector option provide flexible regimens. These new dose amount and the 2 step auto-injector option provide flexibility and convenient self-administration.”

To enhance patients’ and healthcare providers’ experience using YUFLYMA, Celltrion USA offers the Celltrion CONNECT Patient Support Program along with the Celltrion CARES Co-pay Assistance Program. The Patient Support Program for YUFLYMA will provide benefits verification, prior authorization assistance, and co-pay assistance. Eligible patients with private/commercial insurance may receive YUFLYMA for as little as $0 out of pocket per month. Patients who are uninsured or underinsured may be eligible to receive YUFLYMA through the Celltrion CONNECT Patient Assistance Program (PAP). Through these support programs, nurses are available to answer patients’ questions and provide training. For more information, visit www.CelltrionConnect.com.

About YUFLYMA (CT-P17, biosimilar adalimumab-aaty)²
YUFLYMA is the world’s first proposed high-concentration, low-volume and citrate-free adalimumab biosimilar to receive European Commission approval in Europe. 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. YUFLYMA is a recombinant fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody. Following the launch of 40mg/0.4mL in July 2023 and 80mg/0.8mL in December 2023, Celltrion additionally plans to launch additional dosage form of 20mg/0.2mL in the U.S. in late 1Q 2024.

YUFLYMA Important Safety Information²

Serious Infections
Patients treated with YUFLYMA 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 YUFLYMA if a patient develops a serious infection or sepsis.

Reported infections include:
Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease.

Test patients for latent TB before YUFLYMA use and during therapy. Initiate treatment for latent TB prior to YUFLYMA use.

Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.

Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with YUFLYMA 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 YUFLYMA, 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
Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of YUFLYMA and institute appropriate therapy.

Hepatitis B Virus Reactivation
Use of TNF blockers, including YUFLYMA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal.

Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.

Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV and closely monitor such patients for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy.

In patients who develop HBV reactivation, stop YUFLYMA and initiate effective antiviral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of YUFLYMA therapy in this situation and monitor patients closely.

Neurologic Reactions
Use of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or ra.diographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.

Exercise caution in considering the use of YUFLYMA in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of YUFLYMA should be considered if any of these disorders develop. There is a known association between intermediate uveitis and central demyelinating disorders.

Hematologic Reactions
Rare reports of pancytopenia including aplastic anemia have been reported with TNF blocking agents. Adverse reactions of the hematologic system, including medically significant cytopenia, have been infrequently reported with adalimumab products.

Consider discontinuation of YUFLYMA therapy in patients with confirmed significant hematologic abnormalities.

Heart Failure
Cases of worsening congestive heart failure (CHF) and new-onset CHF have been reported with TNF blockers. Cases of worsening CHF have also been observed with adalimumab products.

Exercise caution when using YUFLYMA in patients who have heart failure and monitor them carefully.

Autoimmunity
Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with YUFLYMA, discontinue treatment.

Immunizations
Patients on YUFLYMA may receive concurrent vaccinations, except for live vaccines.

It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating YUFLYMA therapy.

No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab products.

The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

Adverse Reactions
Indications
YUFLYMA 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 for YUFLYMA (adalimumab-aaty)

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, visit www.celltrionusa.com/.

^[1] Symphony Health, IQVIA

^[2] YUFLYMA U.S. prescribing information