Juvenile Idiopathic Arthritis

In the biopharmaceutical industry, a quiet war is unfolding—one that involves billions of dollars in market value, patent strategies, and regulatory frameworks. The patent dispute between Swiss pharmaceutical giant Roche and American biotech heavyweight Biogen over Tocilizumab has emerged as a focal point in the global competition surrounding biosimilars. This lawsuit not only concerns the commercial interests of the two companies but also reflects the deeper conflict between biologic patent protection and biosimilar substitution. Its outcome may reshape the competitive landscape of the biologics market for the next decade. I. Background and Market Landscape: Tocilizumab’s “Patent Cliff” CrisisTocilizumab, developed by Genentech under Roche, is an IL-6 receptor inhibitor that was first approved in 2005 for the treatment of rheumatoid arthritis (RA). Its indications have since expanded to include giant cell arteritis, systemic juvenile idiopathic arthritis, and even severe COVID-19 cases. In 2022, the drug generated global sales of $3.12 billion, accounting for 6.3% of Roche’s pharmaceutical revenue, making it a cornerstone product in Roche’s immunology portfolio. However, with key patents nearing expiration, Roche is facing the looming threat of a "patent cliff." Drug Characteristics and Market Position Tocilizumab works by inhibiting the IL-6 signaling pathway, significantly improving symptoms of inflammatory diseases. Its continuously expanding indications—such as its 2017 FDA approval for cytokine release syndrome associated with CAR-T cell therapy—have further solidified its market presence. In 2022, the U.S. market contributed approximately $1.8 billion to global sales, the European market accounted for $1.2 billion, with the remainder from Asia and other regions. In the RA market, Tocilizumab stands alongside AbbVie’s Humira and Johnson & Johnson’s Stelara in a triad of major players. Its Emergency Use Authorization (EUA) for treating severe COVID-19 positioned it as a "lifesaving anchor" for Roche during the pandemic. Patent Fortification and Challenges Roche has built a multi-layered patent defense system for Tocilizumab: Core Patents: These cover molecular structure (US7855275B2, expiring in 2025) and manufacturing processes (US9458229B2, expiring in 2035). Specifically, US7855275B2 protects the antibody’s amino acid sequence, while US9458229B2 addresses optimized CHO cell culture conditions, including temperature, pH control, and Protein A chromatography in purification steps. Peripheral Patents: These include formulation (US9139643B2, covering a specific ratio of polysorbate 80 and histidine buffer), dosing regimens (US10137106B2, focusing on dose adjustment for giant cell arteritis), and expanded indications (e.g., US10729733B2, covering use in severe COVID-19 cases). In total, Roche holds over 20 patents related to Tocilizumab, forming a "patent thicket" aimed at delaying biosimilar market entry until 2035. However, the emergence of Biogen’s Tocilizumab biosimilar, BIIB800, has disrupted this balance. In 2023, Biogen submitted a Biologics License Application (BLA) to the U.S. FDA for BIIB800 under the streamlined 351(k) pathway. The biosimilar is expected to be priced 30–40% lower than the originator drug, and, if approved, would directly threaten Roche’s market share. Biogen claims it employs a novel continuous-flow bioreactor technology that significantly reduces manufacturing costs. Nonetheless, Roche argues that Biogen’s production process still falls within the scope of its patented technologies—setting the stage for an intense patent litigation battle. II. Legal Battle: A “Carpet-Bombing” Patent Dispute Involving 20 PatentsAt the heart of this lawsuit lies a fierce battle over 20 patents. Roche has accused Biogen’s BIIB800 of infringing upon its patents related to molecular structure, manufacturing processes, formulation compositions, and methods of use. On the molecular level, the specificity of the complementarity-determining region (CDR) sequences in tocilizumab is key to its uniqueness. In terms of manufacturing, Roche emphasizes its proprietary barriers surrounding CHO cell culture conditions and purification steps (such as Protein A chromatography parameters). For the formulation, specific concentrations of stabilizer combinations (polysorbate 80 with a histidine buffer) are included in the patent claims. Additionally, Roche holds a dosing regimen patent for giant cell arteritis, aiming to broaden its patent protection to cover expanded indications. Roche’s Claims ·Molecular Structure Patent Infringement: Roche argues that the antibody CDR sequences of BIIB800 are highly homologous to those of tocilizumab and fall within the protection scope of US7855275B2. Although biosimilars are permitted minor structural variations, Roche insists that its patent claims cover “functionally equivalent” antibodies, and Biogen’s drug shows no significant difference in IL-6 receptor binding affinity compared to the originator product. ·Manufacturing Process Infringement: Roche accuses Biogen of using the same temperature control (36.5±0.5°C) and pH regulation (7.2±0.1) parameters as outlined in US9458229B2 in its CHO cell culture process. Furthermore, the buffer composition for Protein A chromatography allegedly matches that disclosed in the patent. Although Biogen asserts it uses a “perfusion bioreactor” instead of batch culture, Roche contends this technology still falls under the “continuous manufacturing” claims of its patent. ·Formulation and Dosing Regimen Infringement: US9139643B2 claims a stabilizer composition with polysorbate 80 concentrations between 0.01%–0.05%. Roche alleges BIIB800 contains 0.03%, which falls within this range. US10137106B2 protects a “once-weekly 480 mg” dosing regimen for treating giant cell arteritis, and Biogen’s clinical trial data reportedly follows this exact regimen. Biogen’s Defense Strategy Biogen has filed multiple inter partes review (IPR) petitions with the U.S. Patent and Trademark Office (USPTO), arguing that some of the patents are invalid due to “obviousness.” For example, it claims that the dosing regimen in US10137106B2 lacks inventiveness, as it is a modified version of the known rheumatoid arthritis dosage (8 mg/kg), and that no unique efficacy was demonstrated in giant cell arteritis trials. The formulation patent US9139643B2 is also challenged as “obvious,” since polysorbate 80 is a widely used stabilizer in biologics. Biogen further asserts that its use of a perfusion bioreactor allows for reduced cross-batch contamination and more efficient removal of metabolic waste compared to Roche’s batch process. While acknowledging the similarity in temperature and pH parameters, Biogen emphasizes that minor process adjustments (such as a 10% extension in culture duration) place its practices beyond the scope of the patent claims. For the formulation, Biogen states it maintains polysorbate 80 at 0.028%, which it argues is below the lower limit of 0.01% claimed in US9139643B2—citing precision analyses that suggest potential calculation errors in the patent’s claimed concentration range. Procedural Complexity Under the Biologics Price Competition and Innovation Act (BPCIA), Biogen is required to resolve patent disputes with Roche prior to market entry. The two parties have engaged in the so-called “patent dance” as follows: ·March 2023: Biogen provided Roche with its BLA materials, including biosimilarity data, manufacturing descriptions, and clinical trial protocols. ·May 2023: Roche listed 20 potentially infringed patents: 12 related to manufacturing, 5 to formulation, and 3 to method of use. Biogen acknowledged only 5 as potentially applicable and submitted a freedom-to-operate (FTO) analysis, arguing the remaining patents were invalid or irrelevant. ·July 2023: After negotiations broke down, Roche filed a lawsuit in the District Court of Massachusetts, seeking an injunction to block the launch of BIIB800. Roche invoked Section 271 of the U.S. Patent Act, alleging both direct infringement (via manufacture and sale of BIIB800) and induced infringement (by promoting its biosimilarity to Actemra). The case is now at a critical juncture. The USPTO may soon rule on the IPR petitions. If certain patents are invalidated, Roche’s case could be significantly weakened. For instance, if US10137106B2 (the dosing regimen patent) is struck down, Biogen could argue its giant cell arteritis indication is non-infringing. Meanwhile, the district court must decide whether to issue a preliminary injunction. The judge will weigh Roche’s claim of “irreparable harm” (such as irreversible loss of market share upon BIIB800’s entry) against the “public interest” (improved access and lower costs from biosimilar competition). If the injunction is denied, BIIB800 may launch in Q2 2025. If no settlement is reached, the case will proceed to a jury trial, focusing on patent validity, infringement determination, and damage assessment. III. Market Impact: A Life-and-Death Battle Over a $3 Billion MarketFor Roche, the patent battle over tocilizumab is pivotal to the survival of its immunology business. If BIIB800 successfully launches in 2025, Actemra’s U.S. market share could plummet from 90% to 50%, resulting in annual revenue losses exceeding $800 million. More critically, the litigation itself is financially burdensome—estimated at $30–50 million—and carries the risk of reverse compensation should core patents be invalidated. Moreover, other biosimilar manufacturers (such as Samsung Bioepis and Celltrion) may seize the opportunity to accelerate development, potentially triggering a price war that further erodes Roche’s profit margins. Roche’s Defense Costs and Risks In addition to direct litigation expenses, Roche must absorb the costs of responding to patent invalidation challenges (e.g., expert witness fees, technical analyses), with total costs projected to reach $50 million. If core patents are invalidated, Roche may be liable for compensating Biogen for damages incurred due to litigation, such as delays in R&D, which could amount to tens of millions of dollars. Even in the event of a legal victory, the launch of BIIB800 could be delayed until 2026 due to procedural holdups, but competing biosimilars may enter the market sooner, accelerating market fragmentation. Biogen’s Market Opportunity and Risks If Biogen prevails, BIIB800 will become the first approved biosimilar to tocilizumab, with first-year sales projected to reach $400 million. Its pricing strategy—potentially 35% lower than the originator—could make it attractive to hospitals and insurers, particularly in the treatment of severe COVID-19. Success with BIIB800 would establish Biogen as a key player in the biosimilars sector and expedite its pipeline targeting blockbuster drugs such as adalimumab (Humira) and etanercept (Enbrel). However, if the production process fails to fully circumvent Roche’s patents, Biogen may be forced to revise its formulation, resulting in delays in biosimilarity verification or even rejection by the FDA. Industry Ripple Effects The launch of BIIB800 could ignite a price war across similar biologics. For instance, after Samsung Bioepis introduced SB8 (an adalimumab biosimilar) in 2017, Humira’s U.S. price dropped by approximately 40%. Biosimilar developers may increasingly favor challenging peripheral patents within the “patent thicket” rather than confronting core molecule patents directly—shifting industry strategy toward “technical workarounds” rather than outright invalidation. Roche, in turn, may seek to extend market exclusivity through indication expansion (e.g., clinical trials of tocilizumab in Alzheimer’s disease) or by developing long-acting formulations. In 2024, Roche submitted a clinical trial application for a once-monthly subcutaneous formulation. IV. Industry Implications: Patent Strategy Innovation in the Biosimilar EraThis lawsuit has highlighted the fundamental divergence in patent strategies between originator pharmaceutical companies and biosimilar manufacturers. Roche’s “patent thicket” approach—building a multilayered patent network around the core molecule involving structure, process, indication, and formulation—is designed to prolong market exclusivity and delay biosimilar competition. Its dynamic surveillance strategy, such as using AI tools to scan competitor patents and initiate early invalidity challenges, further strengthens its defensive posture. For example, Roche leveraged its patent alert system to detect Samsung Bioepis’s tocilizumab biosimilar development and preemptively filed a lawsuit in 2022, forcing Samsung to revise its strategy. However, this approach is also under pressure: Peripheral patents, such as those covering formulations and dosing regimens, are vulnerable to invalidation on grounds of “obviousness.” For instance, if Biogen’s IPR (Inter Partes Review) challenge succeeds, Roche could lose protection over specific dosing strategies. Additionally, biosimilar companies can avoid infringement by tweaking process parameters—such as extending culture duration or adjusting buffer pH—pressuring originators to draft patent claims with greater technical precision. For biosimilar developers, Biogen’s “precision strike” strategy offers a compelling new blueprint. By conducting Freedom to Operate (FTO) analysis early in the R&D phase, prioritizing challenges against weaker peripheral patents, and adopting technical improvements (e.g., perfusion bioreactors), they can minimize infringement risk. Furthermore, collaborative alternatives to litigation—such as “patent settlement + revenue sharing” agreements with originators—may become more prevalent. For instance, Amgen and Allergan pursued cross-licensing and market allocation agreements in developing a Humira biosimilar, achieving a win-win outcome. Regulatory Transformation U.S. lawmakers may revise the Biologics Price Competition and Innovation Act (BPCIA) to shorten the “patent dance” period and curb procedural abuse by originators. For example, the 2023 proposed “BIOSIM Act” seeks to reduce the preliminary injunction hearing window from 18 to 12 months, and would allow biosimilar applicants to continue their regulatory review process during patent disputes. Meanwhile, regulatory harmonization remains a global challenge: the EU’s biosimilarity standards differ significantly from the U.S. patent dance framework, compelling companies to adopt differentiated patent strategies across jurisdictions. Conclusion: Redefining the Balance Between Innovation and Access in Biologics The Roche-Biogen patent battle ultimately reflects a longstanding tension between incentivizing biologics innovation and ensuring public access to affordable therapies. Originator companies rely on patent protection to recoup R&D investment and drive future breakthroughs, while biosimilar developers aim to reduce costs and improve treatment accessibility. The outcome of this case will directly shape the competitive landscape of the biologics market for the next decade: a win for Roche may encourage wider adoption of “patent thicket” strategies to extend exclusivity, whereas a victory for Biogen could accelerate biosimilar penetration and pressure originators to innovate more rapidly. The implications of this litigation go far beyond the case itself. It forces the industry to reassess the boundaries of patent strategy—should companies maximize commercial gains through “technical barriers,” or promote broader technological access through “open innovation”? Future equilibrium will be shaped by evolving regulatory policies, strategic adaptations by pharmaceutical companies, and growing demands from patients for accessible healthcare. Regardless of the verdict, this case is poised to become a landmark in the legal history of biologics, setting a new benchmark for global pharmaceutical innovation and competition. 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The US Food and Drug Administration (FDA) has designated Celltrion’s Yuflyma (adalimumab-aaty) as an interchangeable biosimilar to AbbVie’s Humira (adalimumab). The decision allows Yuflyma to be substituted for Humira at pharmacies without the intervention of a prescribing healthcare provider, depending on state laws. Yuflyma is approved in the US for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. The high-concentration, citrate-free biosimilar is currently available as a 20mg, 40mg and 80mg solution for injection in a prefilled syringe and auto-injector pen. A biosimilar, according to the FDA, is a biological medicine that is highly similar to one already approved in the US. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product, but may potentially benefit from lower healthcare costs. The regulator’s latest decision on Yuflyma was based on data from a late-stage interchangeability study in patients with moderate-to-severe active plaque psoriasis. Results showed similar pharmacokinetics, efficacy, safety and immunogenicity outcomes in patients who were treated continuously with reference adalimumab and those who alternated between reference adalimumab and Yuflyma during the dosing interval of week 25 to 27. Celltrion USA’s chief commercial officer, Thomas Nusbickel, said the new designation further positions Yuflyma “to help more patients gain access to and afford the therapy they need”. “Yuflyma has the same dosage form, route of administration and dosing regimen as the reference product,” explained Nusbickel. “The pharmacist’s ability to substitute the biosimilar directly at the pharmacy without the hassle of a new prescription and without the patient having to learn a new method of administration can be a game changer in increasing patient access to adalimumab.” The designation comes less than two weeks after the FDA approved Celltrion’s biosimilars referencing Amgen’s bone disease therapy denosumab. The regulator approved Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo) for all indications covered by Amgen’s Prolia and Xgeva, respectively. Nusbickel said the authorisation marked “another step forward in [Celltrion’s] efforts to deliver cost-effective and high-quality treatments that address critical unmet needs in osteoporosis-related fracture as well as cancer-related skeletal events”.

YUFLYMA ® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira ® (adalimumab) biosimilar, that is now interchangeable [1] Interchangeable designation of YUFLYMA ® is supported by positive data from the Phase III interchangeability study in patients with moderate-to-severe plaque psoriasis INCHEON, South Korea, April 14, 2025 /PRNewswire/ -- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated YUFLYMA ® (adalimumab-aaty), as an interchangeable biosimilar to Humira ® (adalimumab). YUFLYMA is an FDA-approved, high-concentration (100mg/mL) and citrate-free formulation of Humira® biosimilar, approved for multiple inflammatory indications.[1] "With this new designation, YUFLYMA is further positioned to help more patients gain access to and afford the therapy they need," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "YUFLYMA has the same dosage form, route of administration, and dosing regimen as the reference product. The pharmacist's ability to substitute the biosimilar directly at the pharmacy without the hassle of a new prescription and without the patient having to learn a new method of administration can be a game changer in increasing patient access to adalimumab." The interchangeable designation was supported by data from the Phase III interchangeability study, which demonstrated similar outcomes in terms of pharmacokinetics, efficacy, safety and immunogenicity in patients with moderately to severely active plaque psoriasis who received reference adalimumab (ADA) continuously and those who alternated between reference ADA and YUFLYMA during the dosing interval of Week 25-27. The result of the interchangeability study was presented at the European Academy of Dermatology & Venereology (EADV) 2024.[2] FDA-approved interchangeable biosimilars may be substituted for the reference product at the pharmacy without the intervention of the prescribing health care provider, subject to state laws.[3] The high-concentration form of YUFLYMA was FDA-approved in May 2023 and is currently available as 20mg, 40 mg and 80mg solution for injection in a prefilled syringe and in an autoinjector pen. YUFLYMA was introduced into the US commercial market on July 2, 2023. YUFLYMA is available in two pricing options to help provide more affordable options for patients. Adalimumab-aaty, the unbranded version, is priced at an 85% discount to the current wholesale acquisition cost (WAC) list price of Humira (adalimumab), providing economic benefits for patients and overall healthcare system. The branded version is priced at a 5% discount to the current WAC of Humira (adalimumab). Notes to Editors: About YUFLYMA® (CT-P17, biosimilar adalimumab-aaty)[1] YUFLYMA is the world's first proposed high-concentration, low-volume and citrate-free adalimumab biosimilar to receive European Commission approval. 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, hidradenitis suppurativa and uveitis. YUFLYMA has been designated by the FDA as an interchangeable biosimilar in a prefilled syringe. YUFLYMA is a recombinant fully human anti–tumor necrosis factor α (anti-TNFα) monoclonal antibody. YUFLYMA is available in 20mg/0.2mL, 40mg/0.4mL and 80mg/0.8mL. 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: 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 adalimumab-aaty use and during therapy. Initiate treatment for latent TB prior to adalimumab-aaty 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 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. Treatment with adalimumab-aaty 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 adalimumab-aaty if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with adalimumab-aaty, 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 adalimumab-aaty 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 adalimumab-aaty and other biologic products for the treatment of RA, PsA, AS, CD, UC, PS, and HS. Concomitant administration of adalimumab-aaty 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 the 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 adalimumab-aaty 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, HS and UV, 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 adalimumab-aaty. In clinical trials of some adalimumab products, there was an approximately 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 severalfold) 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 the 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 adalimumab-aaty and institute appropriate therapy. HEPATITIS B VIRUS REACTIVATION Use of TNF blockers, including adalimumab-aaty, 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 adalimumab-aaty 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 adalimumab-aaty 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 adalimumab-aaty in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of adalimumab-aaty 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 adalimumab-aaty 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 adalimumab-aaty 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 adalimumab-aaty, discontinue treatment. IMMUNIZATIONS Patients on adalimumab-aaty 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 adalimumab-aaty 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. 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 Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients For Yuflyma (adalimumab-aaty): Please click for Full U.S. Prescribing Information. For adalimumab-aaty: Please see Full U.S. Prescribing Information. Globally, prescribing information varies; refer to the individual country product label for complete information. About Celltrion , Inc. Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook. 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's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (ustekinumab-stba), STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo) and OMLYCLO® (omalizumab-igec), as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). 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 and stay updated with our latest news and events on our social media: LinkedIn. 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, Inc. and its subsidiaries that may constitute forward-looking statements under pertinent securities laws. This press release contains forward looking statements. These statements may be also 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", "anticipate" 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, Inc. and its subsidiaries' 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 in respect of 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 associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, 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 statements. Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. Trademarks Humira is a registered trademark of AbbVie. YUFLYMA® is a registered trademark of Celltrion, Inc., used under license. References [1] YUFLYMA US prescribing information (2023) [2] Lebwohl M et al., Pharmacokinetics, Efficacy and Safety after Multiple Switches from Reference Adalimumab to Adalimumab Biosimilar (CT-P17) in comparison with the Maintenance Group (Reference Adalimumab) in Patients with Moderate-toSevere Plaque Psoriasis: Week 27 Results from the Phase III Interchangeability Study. [EADV 2024, Poster number P0931]. Available at: [3] 9 Things to Know About Biosimilars and Interchangeable Biosimilars. Available at : For further information please contact:  Andria Arena [email protected] +1 516-578-0057 SOURCE Celltrion WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED