INCHEON, Korea & JERSEY CITY, N.J.–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced the U.S. Food and Drug Administration (FDA) has approved the citrate-free, high-concentration (100 mg/mL) formulation of HADLIMA� (adalimumab-bwwd), a biosimilar referencing HUMIRA® (adalimumab). HADLIMA will be available in pre-filled syringe and autoinjector options, and the autoinjector was specifically designed with the patient in mind. HADLIMA was previously approved by the FDA as a low-concentration (50 mg/mL) formulation in July 2019 and outside the US that formulation has been available in various markets globally under different brand names, with over 5 million doses sold since 2018.1,2
With this approval, we now have both a low and high concentration adalimumab biosimilar approved by the FDA, marking an important step towards expanding treatment options for patients suffering from certain chronic, autoimmune diseases, said Byoungin Jung, Vice President and Regulatory Affairs Team Leader, Samsung Bioepis. By leveraging our development expertise, manufacturing excellence and supply chain reliability, we will continue our work to ensure healthcare systems have more affordable treatment options available, she added.
Based on our success commercializing our adalimumab biosimilar in other markets around the world, combined with our established presence in the biosimilar space, we are excited about the opportunity to launch HADLIMA in the US in 2023, said Joe Azzinaro, Vice President, Global Commercial Lead Biosimilars, Organon. Today, adalimumab is the largest drug expense in the US. We look forward to making our biosimilar available for those that rely on it to help manage their disease.
The approval of citrate-free, high-concentration HADLIMA was based on clinical data from a randomized, single-blind, two-arm, parallel group, single-dose study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of two formulations of HADLIMA (100 mg/mL vs 50 mg/mL) in healthy volunteers.3
HADLIMA is expected to be launched on or after July 1, 2023 by Organon.
About Biosimilars
A biosimilar is a biologic product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.4 Biologics are the fastest-growing class of therapeutic products in the U.S., and biosimilars can increase competition in the marketplace, potentially lowering health care costs.4 Wider use of biosimilars could result in savings of $100 billion in the U.S. between 2020 to 2024 by stimulating market competition.5
About HADLIMA (adalimumab-bwwd)
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 anti-rheumatic 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.
Crohns Disease – HADLIMA is indicated for the treatment of moderately to severely active Crohns 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 adalimumab products has not been established in patients who have lost response to or were intolerant to 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.
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:
Carefully consider the risks and benefits of treatment with HADLIMA 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 HADLIMA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
Treatment with HADLIMA should not be initiated in patients with an active infection, including localized infections. Patients 65 years of age and older, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Consider the risks and benefits of treatment prior to initiating therapy in patients:
Discontinue HADLIMA if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with HADLIMA, 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 HADLIMA 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 HADLIMA and other biologic products for the treatment of RA, PsA, AS, CD, UC and Ps. Concomitant administration of HADLIMA 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.
MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Post-marketing 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 Crohns 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.
HYPERSENSITIVITY REACTIONS
HEPATITIS B VIRUS REACTIVATION
NEUROLOGIC REACTIONS
HEMATOLOGICAL REACTIONS
INCREASED RISK OF INFECTION WHEN USED WITH ANAKINRA
HEART FAILURE
AUTOIMMUNITY
IMMUNIZATIONS
ADVERSE REACTIONS
The most common adverse reactions in HADLIMA clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headaches, and rash.
Before prescribing HADLIMA, please read the accompanying Prescribing Information, including the Boxed Warning about serious infections and malignancies. The Medication Guide is also available.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, endocrinology, and gastroenterology. For more information, please visit: www.samsungbioepis.com and follow us on social media Twitter, LinkedIn.
About Organon
Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the womens health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organons products produce strong cash flows that will support investments in innovation and future growth opportunities. 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 9,300 employees with headquarters located in Jersey City, New Jersey.
For more information, visit http://www.organon.com and connect with us on LinkedIn and Instagram.
Forward-Looking Statements
Except for historical information herein, this news 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 Organon managements expectations about Organons launch and commercialization of HADLIMA and its collaboration with Samsung Bioepis. Forward-looking statements may be identified by words such as expects, intends, anticipates, plans, believes, seeks, estimates, will or words of similar meaning. These statements are based upon the current beliefs and expectations of Organons 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 or realize the benefits of our planned acquisitions; general economic factors, including interest rate and currency exchange rate fluctuations; general industry conditions and competition; the impact of the ongoing COVID-19 pandemic and emergence of variant strains; 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; Organons ability to accurately predict its future financial results and performance; Organons ability to accurately predict future market conditions; 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 Organons patents and other protections for innovative products; 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 Organons filings with the Securities and Exchange Commission (SEC), including Organons Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent SEC filings, available at the SECs 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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1 HADLIMA Label. August 16, 2022. Available at https://www.organon.com/wp-content/uploads/sites/2/2022/08/FDA_b761059_S005_Hadlima_8.15.22_letterlabeling_002_clean.pdf
2 IQVIA MIDAS data. Worldwide sales of SB5, Samsung Bioepis’s adalimumab biosimilar. As of March 2022
3 Ahn SS, Lee M, Baek Y, Lee S. A randomized phase I pharmacokinetic study comparing high-concentration, low-volume, and citrate-free SB5 (40 mg/0.4 mL) with prior SB5 formulation, and adalimumab biosimilar, in healthy male subjects. Presented at: EULAR 2022; June 1-4, 2022; Copenhagen, Denmark. Abstract POS0641.
4 U.S. Food and Drug Administration. Biosimilar and Interchangeable Products. Available at: https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products. Accessed August 2022.
5 IQVIA Institute for Human Data Science. (October 2020). Biosimilars in the United States 20202024. https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2020-2024. Accessed August 2022
Contacts
Media Samsung Bioepis
Anna Nayun Kim, nayun86.kim@samsung.com
Yoon Kim, yoon1.kim@samsung.com
Media Organon
Karissa Peer, karissa.peer@organon.com
Hannah Silver, hannah.silver@organon.com
Kim Burke Hamilton, kim.hamilton@organon.com
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