INCHEON, Korea & JERSEY CITY, NJ, USA I August 17, 2022 I 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.
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 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.
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 women’s health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s 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.
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 2020–2024.” https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2020-2024. Accessed August 2022
SOURCE: Samsung Bioepis
Post Views: 122
INCHEON, Korea & JERSEY CITY, NJ, USA I August 17, 2022 I 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.
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 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.
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 women’s health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s 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.
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 2020–2024.” https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2020-2024. Accessed August 2022
SOURCE: Samsung Bioepis
Post Views: 122
