JERSEY CITY - 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.

'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 HADLIMATM 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).

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.

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.

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.

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.

Contact:

Karissa Peer

Email: karissa.peer@organon.com

Hannah Silver

Email: hannah.silver@organon.com

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