JERSEY CITY, N.J.--(BUSINESS WIRE)--Celltrion USA, Inc. (Celltrion USA) today announced its FDA-approved biosimilar, YUFLYMA® (adalimumab-aaty), has been added to CarePartners Specialty Pharmacy Cost Savings Programs. YUFLYMA is a high-concentration (100mg/mL) and citrate-free formulation of the Humira® (adalimumab) biosimilar. CarePartners and its strategic partners will offer and distribute YUFLYMA as the lowest net cost high-concentration Humira (adalimumab) biosimilar to over 10 million plan members.
“Care Partners’ decision to add YUFLYMA to its formulary could benefit millions of Americans, bringing value to the healthcare system and patient communities,” said Thomas Nusbickel, Chief Commercial Offer at Celltrion USA. “We are dedicated to improving the lives of patients by expanding biosimilar access and affordability with treatment options backed by a strong, evidence-based efficacy-safety profile.”
More than 80% of patients treated with Humira in the U.S. rely on a high-concentration and citrate-free formulation.1 YUFLYMA provides additional benefits of administration via a latex-free device and a longer shelf life due to its ability to maintain a stability at 77°F for a period up to 30 days, with protection from light.
“We are excited to partner with Celltrion to offer a quality, high-concentration alternative to Humira at the lowest net-cost,” said Kam Ghazvini, RPh, Founder and CEO of CarePartners. “Partnering with Celltrion to offer YUFLYMA solidifies our cost saving initiatives for plan sponsors, employers, health plans, and other payers. We are excited to support Celltrion, a leading biotech company poised to be one of the leaders in the biosimilar landscape with a rich pipeline of blockbuster biosimilars in the years to come.”
On September 29, the U.S. Food and Drug Administration (FDA) has approved additional strengths for YUFLYMA, a high-concentration (100mg/mL) and citrate-free formulation of Humira(adalimumab) biosimilar, in 20mg and 80mg strengths in the United States.
About YUFLYMA® (CT-P17, biosimilar adalimumab-aaty)2
YUFLYMA was the first high-concentration, low-volume, and citrate-free adalimumab biosimilar to receive European Commission approval in the European Union. 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?tumor necrosis factor α (anti-TNFα) monoclonal antibody. Following the launch of 40mg/0.4mL in the U.S. in July 2023, two different types of dosage forms, 80mg/0.8mL, 20mg/0.2mL, were approved by the FDA on September 29, 2023. The full prescribing information can be found at: https://www.celltrionusa.com/data/file/product/Yuflyma%20USPI.pdf
YUFLYMA is a tumor necrosis factor (TNF) blocker indicated for:
Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers
YUFLYMA® IMPORTANT SAFETY INFORMATION
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:
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.
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 use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.
HEPATITIS B VIRUS REACTIVATION
Please see full Prescribing Information for YUFLYMA® (adalimumab-aaty)
About Celltrion USA
Celltrion USA is Celltrion Healthcare’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 USA will continue to leverage Celltrion Healthcare’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. Celltrion Healthcare endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information, please visit: www.celltrionusa.com/
CarePartners is a specialty pharmacy business focused on providing chronic and complex therapies including specialty infusion, specialty pharmacy, and ambulatory infusion services. The CarePartners team is made up of experienced clinicians and experienced support staff dedicated to providing patients with the highest quality service, leveraging a high-touch patient centric model. CarePartners offers innovative cost saving programs with positive clinical outcomes to plan sponsors, employers, unions, PBMs, and health plans. www.CarePartnersRx.com
CarePartners is fully accredited and is licensed to service patients in all 50 states and DC.