Organon Acquires TOFIDENCE™ (tocilizumab-bavi), a Commercialized Biosimilar to ACTEMRA® (tocilizumab) Injection, for Intravenous Infusion in the U.S.

Strengthens and expands U.S. biosimilars immunology portfolio with multi-indication arthritis treatment

Organon (NYSE: OGN), a global healthcare company with a deep expertise in biosimilars, today announced that it has acquired from Biogen Inc. (Nasdaq: BIIB) regulatory and commercial rights in the U.S. for TOFIDENCE^™, a biosimilar to ACTEMRA^®, for intravenous infusion. TOFIDENCE, the first approved tocilizumab biosimilar entrant in the U.S. market, was launched in May 2024 and is indicated in certain patients for the treatment of moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.

“Biosimilars continue to be a key growth driver for Organon, and this acquisition complements our existing business, enabling us to expand our immunology portfolio,” said Kevin Ali, Organon’s Chief Executive Officer. “We believe that by leveraging our commercial expertise and market access capabilities, there is considerable growth potential for this product.”

Under the terms of the agreement, Organon has acquired the regulatory and commercial rights to TOFIDENCE in the U.S., available in three vial sizes, 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL, for further dilution prior to intravenous infusion. Bio-Thera Solutions Ltd., the product developer, will maintain manufacturing rights for TOFIDENCE for the U.S. market.

The agreement includes an upfront payment to Biogen, with Organon assuming the obligation to pay tiered royalty payments based on net sales and tiered annual net sales milestone payments owed by Biogen to Bio-Thera Solutions Ltd.

ABOUT TOFIDENCE (tocilizumab-bavi)

TOFIDENCE (tocilizumab) is a treatment developed as a biosimilar to the reference product ACTEMRA. TOFIDENCE is indicated for the treatment of moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and Coronavirus Disease 2019.

INDICATIONS AND USAGE

Rheumatoid Arthritis (RA)

TOFIDENCE is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).

Giant Cell Arteritis (GCA)

TOFIDENCE is indicated for the treatment of giant cell arteritis in adult patients.

Polyarticular Juvenile Idiopathic Arthritis (PJIA)

TOFIDENCE is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

Systemic Juvenile Idiopathic Arthritis (SJIA)

TOFIDENCE is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.

Coronavirus Disease 2019 (COVID-19)

TOFIDENCE is indicated for the treatment of coronavirus disease 2019 in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

IMPORTANT SAFETY INFORMATION

The U.S. prescribing information for TOFIDENCE includes a boxed WARNING for RISK OF SERIOUS INFECTIONS: Patients treated with tocilizumab products, including TOFIDENCE, are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections. If a serious infection develops, interrupt TOFIDENCE until the infection is controlled.

Reported infections include:

• Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients, except those with COVID-19, should be tested for latent tuberculosis before TOFIDENCE use and during therapy. Treatment for latent infection should be initiated prior to TOFIDENCE use.
• Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
• Bacterial, viral and other infections due to opportunistic pathogens.

The risks and benefits of treatment with TOFIDENCE should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with TOFIDENCE, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

COVID-19

In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with TOFIDENCE.

Tuberculosis

Evaluate patients for tuberculosis risk factors and test for latent infection prior to initiating TOFIDENCE.

Consider anti-tuberculosis therapy prior to initiation of TOFIDENCE in patients with a history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection.

Closely monitor patients for the development of signs and symptoms of tuberculosis including patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Patients with latent tuberculosis should be treated with standard antimycobacterial therapy before initiating TOFIDENCE.

Viral Reactivation

Viral reactivation has been reported with immunosuppressive biologic therapies and cases of herpes zoster exacerbation were observed in clinical studies with tocilizumab.

CONTRAINDICATIONS

TOFIDENCE is contraindicated in patients with known hypersensitivity to tocilizumab products.

WARNINGS AND PRECAUTIONS

GASTROINTESTINAL PERFORATIONS

Use TOFIDENCE with caution in patients who may be at increased risk for gastrointestinal perforation. Promptly evaluate patients presenting with fever, new onset abdominal symptoms, and change in bowel habits for early identification of gastrointestinal perforation.

HEPATOTOXICITY

Serious cases of hepatic injury have been observed in patients taking intravenous tocilizumab products. Some of these cases have resulted in liver transplant or death.

For RA and GCA patients, obtain a liver test panel (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase, and total bilirubin) before initiating TOFIDENCE routinely. It is not recommended to initiate TOFIDENCE treatment in RA and GCA patients with elevated transaminases ALT or AST greater than 1.5x ULN. In patients who develop elevated ALT or AST greater than 5 x ULN, discontinue TOFIDENCE.

It is not recommended to initiate TOFIDENCE treatment in COVID-19 patients with elevated ALT or AST above 10 x ULN. Monitor ALT and AST during treatment.

Measure liver tests promptly in patients who report symptoms that may indicate liver injury, such as fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice. If the patient is found to have abnormal liver tests, TOFIDENCE treatment should be interrupted and investigation done to establish the probable cause. TOFIDENCE should only be restarted in patients with another explanation for the liver test abnormalities after normalization of the liver tests.

A similar pattern of liver enzyme elevation is noted with tocilizumab products treatment in the PJIA and SJIA populations. Monitor liver test panel at the time of the second administration and thereafter every 4 to 8 weeks for PJIA and every 2 to 4 weeks for SJIA.

CHANGES IN LABORATORY PARAMETERS

Patients with RA, GCA and COVID-19:

Neutropenia

Treatment with tocilizumab products was associated with a higher incidence of neutropenia.

Thrombocytopenia

Treatment with tocilizumab products was associated with a reduction in platelet counts.

In COVID-19 patients with a platelet count less than 50,000 per mm³, treatment is not recommended.

Elevated Liver Enzymes

Refer to Hepatotoxicity. (See above.)

Lipid Abnormalities

Treatment with tocilizumab products was associated with increases in lipid parameters such as total cholesterol, triglycerides, LDL cholesterol, and/or HDL cholesterol.

Assess lipid parameters approximately 4 to 8 weeks following initiation of TOFIDENCE therapy.

Patients with Polyarticular and Systemic Juvenile Idiopathic Arthritis:

A similar pattern of liver enzyme elevation, low neutrophil count, low platelet count and lipid elevations is noted with tocilizumab products treatment in the PJIA and SJIA populations. Monitor neutrophils, platelets, ALT and AST at the time of the second administration and thereafter every 4 to 8 weeks for PJIA and every 2 to 4 weeks for SJIA. Monitor lipids as above for approved adult indications.

IMMUNOSUPPRESSION

TOFIDENCE is an immunosuppressant, and treatment with immunosuppressants may result in an increased risk of malignancies.

HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS

Hypersensitivity reactions, including anaphylaxis, have been reported in association with tocilizumab products and anaphylactic events with a fatal outcome have been reported with intravenous infusion of tocilizumab products. Reactions that required treatment discontinuation included generalized erythema, rash, and urticaria.

TOFIDENCE for intravenous use should only be infused by a healthcare professional with appropriate medical support to manage anaphylaxis. If a hypersensitivity reaction occurs immediately discontinue TOFIDENCE; treat promptly and monitor until signs and symptoms resolve.

DEMYELINATING DISORDERS

Prescribers should exercise caution in considering the use of TOFIDENCE in patients with preexisting or recent onset demyelinating disorders.

ACTIVE HEPATIC DISEASE AND HEPATIC IMPAIRMENT

Treatment with TOFIDENCE is not recommended in patients with active hepatic disease or hepatic impairment.

VACCINATIONS

Avoid use of live vaccines concurrently with TOFIDENCE as clinical safety has not been established.

No data are available on the effectiveness of vaccination in patients receiving tocilizumab products. Because IL-6 inhibition may interfere with the normal immune response to new antigens, it is recommended that all patients, particularly pediatric or elderly patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating TOFIDENCE therapy.

ADVERSE REACTIONS

The most common adverse reactions (incidence of at least 5%) associated with tocilizumab-IV were upper respiratory tract infections, nasopharyngitis, headache, hypertension and increased ALT.

DRUG INTERACTIONS

Cytochrome P450s in the liver are down-regulated by infection and inflammation stimuli including cytokines such as IL-6. Inhibition of IL-6 signaling in RA patients treated with tocilizumab products may restore CYP450 activities to higher levels than those in the absence of tocilizumab products leading to increased metabolism of drugs that are CYP450 substrates.

Exercise caution when coadministering TOFIDENCE with CYP3A4 substrate drugs where decrease in effectiveness is undesirable, e.g., oral contraceptives, lovastatin, atorvastatin, etc.

USE IN SPECIFIC POPULATIONS

Pregnancy

The available data with tocilizumab products from a pregnancy exposure registry, retrospective cohort study, pharmacovigilance, and published literature are insufficient to draw conclusions about a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Based on the animal data, there may be a potential risk to the fetus.

Lactation

No information is available on the presence of tocilizumab products in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Discontinue drug or nursing taking into consideration the importance of the drug to the mother.

Before prescribing, please read the full Prescribing Information.

About Organon

Organon is an independent global healthcare company with a mission to help improve the health of women throughout their lives. Organon’s diverse portfolio offers over 70 medicines and products in women’s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon’s current products, the company invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars. Organon is also pursuing opportunities to collaborate with biopharmaceutical partners and innovators who look to commercialize their products by leveraging Organon’s scale and agile presence in fast growing international markets.

Organon has geographic scope with significant reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.

For more information, visit http://www.organon.com and connect with us on LinkedIn, Instagram, X (formerly known as Twitter) and Facebook.

Cautionary Note Regarding Forward-Looking Statements

Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about the potential benefits of Organon’s acquisition of regulatory and commercialization rights to TOFIDENCE in the U.S. Forward-looking statements may be identified by words such as “believe,” “will,” “potential,” “future,” “pursuing,” “opportunity,” or words of similar meaning. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include, but are not limited to, an inability to execute on our business development strategy; weakening of economic conditions that could adversely affect the level of demand for TOFIDENCE; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and health care reform, pharmaceutical reimbursement and pricing in general; an inability to fully execute on Organon’s product development and commercialization plans; governmental initiatives that adversely impact Organon’s marketing activities; manufacturing difficulties or delays; the failure of any supplier to provide substances, materials, or services as agreed; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties, including Bio-Thera Solutions, Ltd.; competition from generic products as our products lose patent protection; disruptions at the U.S. Food and Drug Administration, the U.S. Securities and Exchange Commission (the “SEC”) and other U.S. and comparable foreign government agencies; and the failure by us or our third party collaborators and/or their suppliers to fulfill our or their regulatory or quality obligations. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s filings with the SEC, including the company’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov). References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Organon is not responsible for the contents of third-party websites.

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