Placulumab

YUFLYMA® (adalimumab-aaty) was first approved by the Food and Drug Administration on May 23, 2023 and became commercially available in the U.S. on July 2, 2023 The treatment will be available on CarePartners Specialty Pharmacy Program in late October and will make YUFLYMA accessible to over 10 million lives The inclusion of YUFLYMA creates greater accessibility to treatments for Americans 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. <End> 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: 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 YUFLYMA® IMPORTANT SAFETY INFORMATION 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. Treatment with YUFLYMA should not be initiated in patients with an active infection, including localized infections. Patients over 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Discontinue YUFLYMA if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with YUFLYMA, closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy. Drug interactions with biologic products: In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF blockers with anakinra or abatacept, with no added benefit; therefore, use of YUFLYMA with abatacept or anakinra is not recommended in patients with RA. A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF blocker. There is insufficient information regarding the concomitant use of YUFLYMA and other biologic products for the treatment of RA, PsA, AS, CD, UC, PS, and HS. Concomitant administration of YUFLYMA with other biologic DMARDS (e.g., anakinra and abatacept) or other TNF blockers is not recommended based upon the possible increased risk for infections and other potential pharmacological interactions. A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. 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 use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants. Consider the risks and benefits of TNF blocker treatment including YUFLYMA prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC), or when considering continuing a TNF blocker in patients who develop a malignancy. In controlled portions of clinical trials of some adalimumab products, more cases of malignancies have been observed compared to control-treated adult patients. Non-melanoma skin cancer (NMSC) was reported during clinical trials for patients treated with adalimumab products. During the controlled portions of 39 global adalimumab clinical trials in adult patients with RA, PsA, AS, CD, UC, PS and HS, the rate (95% confidence interval) of NMSC was 0.8 (0.52, 1.09) per 100 patient-years among adalimumab-treated patients and 0.2 (0.10, 0.59) per 100 patient-years among control-treated patients. Examine all patients, particularly those with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of PUVA treatment, for the presence of NMSC prior to and during treatment with YUFLYMA. In clinical trials of some adalimumab products, there was an approximate threefold higher rate of lymphoma than expected in the general U.S. population. Patients with RA and other chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to several fold) than the general population for the development of lymphoma, even in the absence of TNF blockers. Postmarketing cases of acute and chronic leukemia were reported with use of a TNF blocker in RA and other indications. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving adalimumab were lymphomas; other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. 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 radiographic 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 The most common adverse reactions in adalimumab clinical trials (>10%) were infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash. 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: About CarePartners 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. CarePartners is fully accredited and is licensed to service patients in all 50 states and DC. References Symphony Health, IQVIA YUFLYMA US prescribing information (2023)

This is the second deal announced between Rani and Celltrion, building upon a previously announced partnership for ustekinumab biosimilar for RT-111 SAN JOSE, CA, USA I June 05, 2023 I Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced that it has expanded its partnership with Celltrion by entering into an agreement for the development of RT-105, an orally administered adalimumab biosimilar. Rani’s first partnership with Celltrion, for the development of RT-111, an orally administered ustekinumab biosimilar, was announced in January of this year. Under the terms of the new license and supply agreement, Celltrion will exclusively supply to Rani the adalimumab biosimilar drug substance (CT-P17) required for RT-105. Rani is granted an exclusive license to use CT-P17 in the development and commercialization of RT-105, and Celltrion is granted a right of first negotiation to acquire worldwide rights to RT-105 following a Phase 1 study. “We are delighted to expand our partnership with Celltrion, a world-class pharmaceutical company, a leader in biosimilars and our valued partner,” said Talat Imran, CEO of Rani. “We believe this expansion of the Rani-Celltrion relationship further validates our RaniPill ® platform and offers the potential to deliver great value for both our companies. We look forward to advancing both RT-105 and RT-111 as oral alternatives to painful injections for people with chronic inflammatory conditions.” Rani has developed an oral delivery technology known as the RaniPill ® capsule, which is intended to replace subcutaneous or intravenous injection of biologics and drugs with oral dosing. The RaniPill ® capsule is designed to administer biologics and drugs with bioavailability comparable to subcutaneous injection. The RaniPill ® platform is payload-agnostic and has the potential to create an oral option for almost any biologic or drug, regardless of modality or therapeutic area. In this agreement with Celltrion, Rani is applying its oral delivery technology to a TNF- α antibody for the potential treatment of inflammatory diseases. “We are pleased to build upon our existing partnership with Rani, a company that is pioneering oral drug delivery across a broad range of injectable therapeutics,” said SungHyun Kim, Head of Medical Science Division. "The cooperation between our companies allows each of us to pursue our commitment to delivering effective and convenient medicines, which in time could benefit healthcare systems, providers and patients.” This is the first announced partnership for a program involving the RaniPill ® HC, a high-capacity device that is designed to deliver up to 20mg of payload with high bioavailability and is in preclinical testing. About Rani Therapeutics Rani Therapeutics is a clinical stage biotherapeutics company focused on advancing technologies to enable the development of orally administered biologics and drugs. Rani has developed the RaniPill ® capsule, which is a novel, proprietary and patented platform technology, intended to replace subcutaneous injection or intravenous infusion of biologics and drugs with oral dosing. Rani has successfully conducted several preclinical and clinical studies to evaluate safety, tolerability and bioavailability using RaniPill ® capsule technology. For more information, visit www.ranitherapeutics.com . SOURCE: Rani Therapeutics