Organon Announces HADLIMA™ (adalimumab-bwwd) Has Been Exclusively Selected by the US Department of Veterans Affairs (VA), Replacing HUMIRA on Its National Formulary

Organon (NYSE:OGN), a global healthcare company with a dedicated commitment to biosimilars, announced that the US Department of Veterans Affairs (VA) has exclusively selected HADLIMA in replacement of HUMIRA (adalimumab) for the VA National Formulary. HADLIMA is an FDA-approved biosimilar to HUMIRA for the treatment of specific autoimmune or autoinflammatory conditions such as rheumatoid arthritis, Crohn's disease, hidradenitis suppurativa, and plaque psoriasis (see full indications below).

"America's veterans deserve access to quality medicines at a lower cost. We are proud to support the more than nine million people enrolled in the VA healthcare system through this collaboration, which is a great example of industry and public sector working together," said Kevin Ali, Organon CEO. "We applaud the VA for its leadership in championing biosimilars and including all three of Organon's biosimilars available in the US on its formulary."

HADLIMA was launched in the US to offer patients a more affordable option without compromising on safety and efficacy. HADLIMA is FDA approved in both citrate-free high concentration (40 mg/0.4 mL), the most-utilized formulation of the originator, and citrate-containing low concentration (40 mg/0.8 mL) formulations to provide patients with continuity of care. Intended to fit into a patient's lifestyle, HADLIMA is available in both a pre-filled syringe and autoinjector option. The HADLIMA^TM PushTouch™ Autoinjector was specifically designed with the patient in mind, with a thin 29G needle, a latex-free needle cover, and a buttonless device with a sure-grip shape and a non-slip surface. The PushTouch Autoinjector has been awarded the Arthritis Foundation's Ease of Use Certification, which recognizes products that make life easier for those living with arthritis and other functional limitations via lab and patient testing by the Intuitive Design Applied Research Institute (IDARI).¹

Patients treated with adalimumab products, including HADLIMA, are at increased risk for developing serious infections that may lead to hospitalization or death. Discontinue HADLIMA if a patient develops a serious infection or sepsis. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HADLIMA, including the possible development of tuberculosis (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. See additional safety information below.

About HADLIMA™ (adalimumab-bwwd) Injection, 40 mg/0.4 mL and 40 mg/0.8 mL

HADLIMA is a tumor necrosis factor (TNF) blocker indicated for:

• Rheumatoid Arthritis: HADLIMA is indicated, alone or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs), for 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 rheumatoid arthritis.
  
  
  
  
• Juvenile Idiopathic Arthritis: HADLIMA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
  
  
  
  
• Psoriatic Arthritis: HADLIMA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
  
  
  
  
• Ankylosing Spondylitis: HADLIMA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
  
  
  
  
• Crohn's Disease: HADLIMA is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older.
  
  
  
  
• Ulcerative Colitis: HADLIMA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.
  
  
  
  Limitations of Use:
  
  The effectiveness of HADLIMA has not been established in patients who have lost response to or were intolerant to tumor necrosis factor (TNF) blockers.
  
  
  
  
• Plaque Psoriasis: HADLIMA is indicated for the 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. HADLIMA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
  
  
  
  
• Hidradenitis Suppurativa: HADLIMA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients.
  
  
  
  
• Uveitis: HADLIMA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

SELECTED SAFETY INFORMATION

SERIOUS INFECTIONS

Patients treated with adalimumab products, including HADLIMA, 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 HADLIMA 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 HADLIMA use and during therapy. Initiate treatment for latent TB prior to HADLIMA 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 anti-fungal 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 HADLIMA prior to initiating therapy in patients:

• with chronic or recurrent infection
• who have been exposed to TB
• with a history of opportunistic infection
• who resided in or traveled in regions where mycoses are endemic
• with underlying conditions that may predispose them to infection

Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HADLIMA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

• Do not start HADLIMA during an active infection, including localized infections.
• Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
• If an infection develops, monitor carefully and initiate appropriate therapy.
• Drug interactions with biologic products: A higher rate of serious infections has been observed in rheumatoid arthritis (RA) patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HADLIMA with other biologic DMARDs (eg, anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.

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 HADLIMA treatment prior to initiating or continuing therapy in a patient with known malignancy.
• In clinical trials, more cases of malignancies were observed among adalimumab-treated patients compared to control patients.
• Non-melanoma skin cancer (NMSC) was reported during clinical trials for adalimumab-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or psoralen and ultraviolet A (PUVA) therapy, for the presence of NMSC prior to and during treatment with HADLIMA.
• In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.
• Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.

HYPERSENSITIVITY

Anaphylaxis and angioneurotic edema have been reported following adalimumab administration. If a serious allergic reaction occurs, stop HADLIMA and institute appropriate therapy.

HEPATITIS B VIRUS REACTIVATION

Use of TNF blockers, including HADLIMA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.

Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.

Exercise caution in patients who are carriers of HBV and monitor them during and after HADLIMA treatment.

Discontinue HADLIMA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HADLIMA after HBV treatment.

NEUROLOGIC REACTIONS

TNF blockers, including adalimumab products, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome.

Exercise caution when considering HADLIMA for patients with these disorders; discontinuation of HADLIMA should be considered if any of these disorders develop.

HEMATOLOGIC REACTIONS

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab products.

Consider stopping HADLIMA if significant hematologic abnormalities occur.

CONGESTIVE HEART FAILURE

Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with adalimumab products; exercise caution and monitor carefully.

AUTOIMMUNITY

Treatment with adalimumab 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.

IMMUNIZATIONS

Patients on HADLIMA should not receive live vaccines.

Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HADLIMA therapy.

Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero-exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products 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 (eg, upper respiratory, sinusitis), injection site reactions, headache, and rash.

Before prescribing HADLIMA, please read the accompanying Prescribing Information, including the Boxed Warning about serious infections and malignancies. The Medication Guide and Instructions for Use also are available.

About Organon

Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon offers more than 60 medicines and products in women's health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon's existing products produce strong cash flows that support investments in innovation and future growth opportunities in women's health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets.

Organon has a global footprint with significant scale and geographic 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

Some statements and disclosures in this press release are "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 Organon's expectations regarding HADLIMA™ and its selection for inclusion in the VA National Formulary for veterans. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as "may," "expects," "intends," "anticipates," "plans," "believes," "seeks," "estimates," "will," or words of similar meaning. These forward-looking statements are based on Organon's current plans and expectations and are subject to a number of risks and uncertainties that could cause Organon's plans and expectations, including actual results, to differ materially from the forward-looking statements.

Risks and uncertainties that may affect Organon's future results include, but are not limited to, an inability to fully execute on the product development and commercialization plans for HADLIMA in the United States due to Organon's inability to realize the benefits of its SB5 HADLIMA biosimilar; any future discontinuation of the inclusion of HADLIMA in the VA National Formulary for veterans; efficacy, safety, or other quality concerns with respect to marketed products, including market actions such as recalls, withdrawals, or declining sales; political and social pressures, or regulatory developments, that adversely impact demand for, availability of, or patient access to Organon's products; general economic factors, including recessionary pressures, interest rate and currency exchange rate fluctuations; general industry conditions and competition; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances; new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Organon's ability to accurately predict its future financial results and performance; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; difficulties developing and sustaining relationships with commercial counterparties; dependence on the effectiveness of Organon's patents and other protections for innovative products; the impact of the ongoing COVID-19 pandemic and emergence of variant strains; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Organon 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 Organon's filings with the Securities and Exchange Commission ("SEC"), including Organon's most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC's Internet site (www.sec.gov).

¹ HADLIMA Prefilled syringe and autoinjector Ease of Use Certification. Arthritis Foundation. July 1, 2023. Accessed February 12, 2024. https://www.arthritis.org/partnership/ease-of-use-certification

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