On November 3, 2026 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Samsung Bioepis Co., Ltd. reported that they have entered into a license and commercialization agreement for two FDA-approved immunology biosimilars: infliximab-abda, a biosimilar to Remicade1 (infliximab) and ETICOVO (etanercept-ykro), a biosimilar to Enbrel2 (etanercept).
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Under the terms of the agreement, Teva will obtain U.S. commercialization rights to etanercept-ykro at closing, while U.S. commercialization rights to infliximab-abda will transfer to Teva in Q3 2027. The timing of Teva’s future U.S. commercialization of etanercept-ykro will be announced at a later date. Samsung Bioepis will remain responsible for regulatory oversight and manufacturing of both products. The transaction is subject to customary closing conditions, including receipt of necessary regulatory approvals, and is currently anticipated to close by the end of 2026.
"This agreement strengthens our collaboration with Samsung Bioepis and will expand our U.S. immunology portfolio with two additional biologic treatment options," said Richard Francis, President and CEO of Teva. "Biosimilars are an important part of our Pivot to Growth strategy, helping us build a stronger portfolio while expanding access to high-quality medicines. Together, we have an opportunity to bring more treatment choices to patients living with chronic inflammatory conditions."
"We are delighted to expand our strategic alliance with Teva to strengthen the commercial footprint of our immunology portfolio in the U.S.," said Kyung-Ah Kim, President and Chief Executive Officer of Samsung Bioepis. "Infliximab-abda has established a proven track record of clinical efficacy and supply reliability since its launch, while ETICOVO represents an FDA-approved therapy poised to broaden treatment choices for patients. By pairing our dedication to high-quality biologic development and manufacturing with Teva’s commercial reach across U.S. healthcare channels, we aim to ensure uninterrupted treatment continuity for existing patients and bring sustainable value to the U.S. healthcare system."
Under the terms of the agreement and subject to certain conditions, Teva will pay Samsung Bioepis an upfront payment over the next 3 years. Samsung Bioepis may be eligible for additional launch and sales milestones payments. Teva and Samsung Bioepis will share profit from the commercialization of these products.
The agreement builds on a series of biosimilar collaborations between Teva and Samsung Bioepis. In 2025, the companies announced a U.S. agreement for EPYSQLI (eculizumab-aagh), a biosimilar to Soliris3 (eculizumab). In 2026, the companies announced two agreements, including one for OPUVIZ (aflibercept) in Canada and a separate global agreement to license, develop and commercialize up to six potential biosimilar candidates currently in early-stage development, including biosimilar candidates referencing Fasenra4 (benralizumab) and Ilaris5 (canakinumab).
About Infliximab-abda and etanercept-ykro
Both biosimilars are tumor necrosis factor (TNF) inhibitors indicated for the treatment of chronic inflammatory and autoimmune conditions:
infliximab-abda6 was approved by the FDA in 2017 for indications including Crohn’s disease (adult and pediatric), ulcerative colitis (adult and pediatric), rheumatoid arthritis (in combination with methotrexate), ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. Teva will newly assume commercialization of the product, scheduled to take effect in the third quarter of 2027.
etanercept-ykro7 was approved by the FDA in 2019 and is not currently available on the U.S. market. It is approved for indications including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis (patients aged 2 years and older), psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis (patients aged 4 years and older).
IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR INFLIXIMAB-ABDA
SERIOUS INFECTIONS
Patients treated with infliximab products 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 infliximab-abda if a patient develops a serious infection or sepsis.
Reported infections include:
Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before infliximab-abda use and during therapy. Treatment for latent infection should be initiated prior to infliximab-abda use.
Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis, and cryptococcosis. Patients may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella, Listeria, and Salmonella.
The risks and benefits of treatment with infliximab-abda should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with infliximab-abda, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy, who are on treatment for latent TB, or who were previously treated for TB infection.
Risk of infection may be higher in patients greater than 65 years of age, pediatric patients, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with infliximab products included pneumonia, cellulitis, abscess, and skin ulceration.
MALIGNANCIES
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab products. Approximately half of these cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.
Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis and most 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. Carefully assess the risks and benefits of treatment with infliximab-abda, especially in these patient types.
In clinical trials of all TNF inhibitors, more cases of lymphoma were observed compared with controls and the expected rate in the general population. However, patients with Crohn’s disease, rheumatoid arthritis, or plaque psoriasis may be at higher risk for developing lymphoma. In clinical trials of some TNF inhibitors, including infliximab products, more cases of other malignancies were observed compared with controls. The rate of these malignancies among patients treated with infliximab products was similar to that expected in the general population whereas the rate in control patients was lower than expected. Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use. As the potential role of TNF inhibitors in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy or other risk factors such as chronic obstructive pulmonary disease (COPD).
Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocker therapy, including infliximab products. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.
A population-based retrospective cohort study found a 2- to 3-fold increase in the incidence of invasive cervical cancer in women with rheumatoid arthritis treated with infliximab compared to biologics-naïve patients or the general population, particularly those over 60 years of age. A causal relationship between infliximab products and cervical cancer cannot be excluded. Periodic screening should continue in women treated with infliximab products.
CONTRAINDICATIONS
The use of infliximab-abda at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure. infliximab-abda is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab products or any of the inactive ingredients of infliximab-abda or any murine proteins (severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness).
WARNINGS AND PRECAUTIONS
HEPATITIS B REACTIVATION
TNF inhibitors, including infliximab products, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating INFLIXIMAB-ABDA. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing infliximab-abda for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with INFLIXIMAB-ABDA. Discontinue infliximab-abda in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of infliximab-abda and monitor patients closely.
HEPATOTOXICITY
Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported rarely in patients receiving infliximab products postmarketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, infliximab-abda should be discontinued, and a thorough investigation of the abnormality should be undertaken.
HEMATOLOGIC EVENTS
Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported in patients using infliximab products. The causal relationship to infliximab therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of infliximab-abda in patients who develop significant hematologic abnormalities.
HYPERSENSITIVITY
Infliximab products have been associated with hypersensitivity reactions that differ in their time of onset and required hospitalization in some cases. Most hypersensitivity reactions (including anaphylaxis, urticaria, dyspnea, and/or hypotension) have occurred during or within 2 hours of infliximab product infusion. Serious infusion reactions including anaphylaxis were infrequent. infliximab-abda should be discontinued for severe hypersensitivity reactions. Medications for the treatment of hypersensitivity reactions should be available.
CARDIOVASCULAR AND CEREBROVASCULAR REACTIONS DURING AND AFTER INFUSION
Serious cerebrovascular accidents, myocardial ischemia/infarction (some fatal), hypotension, hypertension, and arrhythmias have been reported during and within 24 hours of initiation of infliximab infusion. Cases of transient visual loss have been reported during or within 2 hours of infusion of infliximab. Monitor patients during infusion and, if a serious reaction occurs, discontinue infusion. Manage reactions according to signs and symptoms.
NEUROLOGIC EVENTS
TNF inhibitors, including infliximab products, have been associated in rare cases with central nervous system (CNS) manifestation of systemic vasculitis, seizure, and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering infliximab-abda in patients with these disorders and consider discontinuation if these disorders develop.
AUTOIMMUNITY
Treatment with infliximab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.
DRUG INTERACTIONS
USE WITH OTHER DRUGS
Concurrent use of infliximab-abda with other biological products used to treat the same conditions as infliximab-abda is not recommended because of the possibility of an increased risk of infection. Care should be taken when switching from one biologic to another, since overlapping biological activity may further increase the risk of infection.
VACCINATIONS AND USE OF LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS
Prior to initiating infliximab-abda in pediatric and adult patients, update vaccinations in accordance with current vaccination guidelines. Live vaccines or therapeutic infectious agents should not be given with infliximab-abda due to the possibility of clinical infections, including disseminated infections.
At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to infliximab products.
ADVERSE REACTIONS
In clinical trials, the most common adverse reactions occurring in >10% of patients included infections (e.g., upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.
INDICATIONS
Infliximab-abda is a TNF blocker indicated for:
Crohn’s Disease
Infliximab-abda is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response to conventional therapy.
Infliximab-abda is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn’s disease.
Pediatric Crohn’s Disease
Infliximab-abda is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age or older with moderately to severely active Crohn’s disease (CD) who have had an inadequate response to conventional therapy.
Ulcerative Colitis
Infliximab-abda is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.
Pediatric Ulcerative Colitis
Infliximab-abda is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.
Rheumatoid Arthritis
Infliximab-abda is indicated, in combination with methotrexate (MTX), for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA).
Ankylosing Spondylitis
Infliximab-abda is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS).
Psoriatic Arthritis
Infliximab-abda is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients with psoriatic arthritis (PsA).
Plaque Psoriasis
Infliximab-abda is indicated for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis (Ps) who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. Infliximab-abda should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
Please read the Full Prescribing Information, including BOXED WARNINGS and Medication Guide.
(Press release, Teva, NOV 3, 2026, View Source [SID1234674124])