Adalimumab-adbm will be priced at an 81% discount to Humira® (adalimumab)
RIDGEFIELD, CT, USA I October 2, 2023 I Boehringer Ingelheim announced today that Adalimumab-adbm injection, the company’s interchangeable* biosimilar to Humira® (adalimumab), is now available at a low wholesale acquisition cost (WAC). Adalimumab-adbm is approved to treat multiple chronic inflammatory diseases and will be priced at an 81% discount to Humira. It is also available under the brand name Cyltezo®, which launched in July 2023 and is priced at a 5% discount to Humira.
“We understand that finding affordable medications is a persistent challenge for many, which is why we strive to ensure our products are widely accessible,” said Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim. “Biosimilars are intended to contribute to the economic sustainability of healthcare systems, and it is our hope that this dual pricing approach will contribute to that sustainability, improve access to Adalimumab-adbm and help meet the varied needs of people with a variety of chronic inflammatory diseases.”
Adalimumab-adbm is interchangeable* to Humira and is a citrate-free formulation, available as 40 mg/0.8 mL, 20 mg/0.4 mL and 10 mg/0.2 mL pre-filled syringes and as a 40 mg/0.8 mL pre-filled autoinjector.
*Interchangeable for the conditions of use, strengths, dosage forms, and routes of administration described in its full Prescribing Information.
About Biosimilars
A biosimilar is a biologic medicine that is developed to be highly similar to an approved reference biologic, with no clinically meaningful differences in terms of safety, potency and purity.
A biosimilar with an interchangeable designation, which is designated by the FDA, may be auto-substituted for the reference product by a pharmacist. Individual state laws control how and whether providers and patients must be notified. An interchangeable biosimilar first must meet the high FDA standards of a biosimilar. Then, to achieve the interchangeable designation, the FDA requires additional data, which may include a study of multiple substitutions in patients, known as a switching study. The study must show that patients can be switched with no increased risk in terms of safety or diminished efficacy compared with remaining on the reference product in any given patient.
About Boehringer Ingelheim in Biologics and Biosimilars
Through novel biologics and our interchangeable biosimilar, we strive to increase the availability of safe, effective, high-quality therapeutic options to patients worldwide.
Boehringer Ingelheim is one of the largest producers of biologic medicines in the world, producing biologic medicines to support our diverse pipeline, as well as other companies’ biopharmaceuticals on a contract basis. As a pioneer in biologics, to date, Boehringer Ingelheim’s Biopharmaceutical Contract Manufacturing business has supported our customers to bring dozens of biologics to the market in therapeutic areas that include oncology, immunology and cardiovascular indications. For more information about Boehringer Ingelheim’s Biopharma and manufacturing capabilities, please click here: https://www.boehringer-ingelheim.com/us/biopharma/biosimilars.
For more information, please see full Prescribing Information, including Medication Guide and Instructions for Use.
What is Adalimumab-adbm injection, for subcutaneous use?
This information also applies to CYLTEZO® (adalimumab-adbm) injection for subcutaneous use.
Adalimumab-adbm is a medicine called a tumor necrosis factor (TNF) blocker. Adalimumab-adbm is used:
- To reduce the signs and symptoms of:
- moderate to severe rheumatoid arthritis (RA) in adults. Adalimumab-adbm can be used alone, with methotrexate, or with certain other medicines.
- moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older. Adalimumab-adbm can be used alone or with methotrexate.
- psoriatic arthritis (PsA) in adults. Adalimumab-adbm can be used alone or with certain other medicines.
- ankylosing spondylitis (AS) in adults.
- moderate to severe hidradenitis suppurativa (HS) in adults.
- To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
- To treat moderate to severe ulcerative colitis (UC) in adults. It is not known if adalimumab products are effective in people who stopped responding to or could not tolerate TNF-blocker medicines.
- To treat moderate to severe chronic (lasting a long time) plaque psoriasis (Ps) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
- To treat non-infectious intermediate, posterior, and panuveitis in adults.
For more information, please see full Prescribing Information, including Medication Guide and Instructions for Use.
About Boehringer Ingelheim
Boehringer Ingelheim is working on potential breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. More than 52,000 employees serve over 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing.
For more information, please visit www.boehringer-ingelheim.com/us/.
Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the Cyltezo® trademark under license. The other trademarks referenced above are owned by third parties not affiliated with Boehringer Ingelheim Pharmaceuticals, Inc.
MPR-US-102785 09/23
CONTACTS:
Taylor Pepe
Sr. Associate Director
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: taylor.pepe@boehringer-ingelheim.com
Phone: (518) 466-3621
SOURCE: Boehringer Ingelheim Pharmaceuticals
Post Views: 103
Adalimumab-adbm will be priced at an 81% discount to Humira® (adalimumab)
RIDGEFIELD, CT, USA I October 2, 2023 I Boehringer Ingelheim announced today that Adalimumab-adbm injection, the company’s interchangeable* biosimilar to Humira® (adalimumab), is now available at a low wholesale acquisition cost (WAC). Adalimumab-adbm is approved to treat multiple chronic inflammatory diseases and will be priced at an 81% discount to Humira. It is also available under the brand name Cyltezo®, which launched in July 2023 and is priced at a 5% discount to Humira.
“We understand that finding affordable medications is a persistent challenge for many, which is why we strive to ensure our products are widely accessible,” said Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim. “Biosimilars are intended to contribute to the economic sustainability of healthcare systems, and it is our hope that this dual pricing approach will contribute to that sustainability, improve access to Adalimumab-adbm and help meet the varied needs of people with a variety of chronic inflammatory diseases.”
Adalimumab-adbm is interchangeable* to Humira and is a citrate-free formulation, available as 40 mg/0.8 mL, 20 mg/0.4 mL and 10 mg/0.2 mL pre-filled syringes and as a 40 mg/0.8 mL pre-filled autoinjector.
*Interchangeable for the conditions of use, strengths, dosage forms, and routes of administration described in its full Prescribing Information.
About Biosimilars
A biosimilar is a biologic medicine that is developed to be highly similar to an approved reference biologic, with no clinically meaningful differences in terms of safety, potency and purity.
A biosimilar with an interchangeable designation, which is designated by the FDA, may be auto-substituted for the reference product by a pharmacist. Individual state laws control how and whether providers and patients must be notified. An interchangeable biosimilar first must meet the high FDA standards of a biosimilar. Then, to achieve the interchangeable designation, the FDA requires additional data, which may include a study of multiple substitutions in patients, known as a switching study. The study must show that patients can be switched with no increased risk in terms of safety or diminished efficacy compared with remaining on the reference product in any given patient.
About Boehringer Ingelheim in Biologics and Biosimilars
Through novel biologics and our interchangeable biosimilar, we strive to increase the availability of safe, effective, high-quality therapeutic options to patients worldwide.
Boehringer Ingelheim is one of the largest producers of biologic medicines in the world, producing biologic medicines to support our diverse pipeline, as well as other companies’ biopharmaceuticals on a contract basis. As a pioneer in biologics, to date, Boehringer Ingelheim’s Biopharmaceutical Contract Manufacturing business has supported our customers to bring dozens of biologics to the market in therapeutic areas that include oncology, immunology and cardiovascular indications. For more information about Boehringer Ingelheim’s Biopharma and manufacturing capabilities, please click here: https://www.boehringer-ingelheim.com/us/biopharma/biosimilars.
For more information, please see full Prescribing Information, including Medication Guide and Instructions for Use.
What is Adalimumab-adbm injection, for subcutaneous use?
This information also applies to CYLTEZO® (adalimumab-adbm) injection for subcutaneous use.
Adalimumab-adbm is a medicine called a tumor necrosis factor (TNF) blocker. Adalimumab-adbm is used:
- To reduce the signs and symptoms of:
- moderate to severe rheumatoid arthritis (RA) in adults. Adalimumab-adbm can be used alone, with methotrexate, or with certain other medicines.
- moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older. Adalimumab-adbm can be used alone or with methotrexate.
- psoriatic arthritis (PsA) in adults. Adalimumab-adbm can be used alone or with certain other medicines.
- ankylosing spondylitis (AS) in adults.
- moderate to severe hidradenitis suppurativa (HS) in adults.
- To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
- To treat moderate to severe ulcerative colitis (UC) in adults. It is not known if adalimumab products are effective in people who stopped responding to or could not tolerate TNF-blocker medicines.
- To treat moderate to severe chronic (lasting a long time) plaque psoriasis (Ps) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
- To treat non-infectious intermediate, posterior, and panuveitis in adults.
For more information, please see full Prescribing Information, including Medication Guide and Instructions for Use.
About Boehringer Ingelheim
Boehringer Ingelheim is working on potential breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. More than 52,000 employees serve over 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing.
For more information, please visit www.boehringer-ingelheim.com/us/.
Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the Cyltezo® trademark under license. The other trademarks referenced above are owned by third parties not affiliated with Boehringer Ingelheim Pharmaceuticals, Inc.
MPR-US-102785 09/23
CONTACTS:
Taylor Pepe
Sr. Associate Director
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: taylor.pepe@boehringer-ingelheim.com
Phone: (518) 466-3621
SOURCE: Boehringer Ingelheim Pharmaceuticals
Post Views: 103
