Friday, 22 Sep 2023

US FDA Approves the Cyltezo Pen, a New Autoinjector Option, Ahead of July 1 Commercial Launch

RIDGEFIELD, Conn., May 22, 2023 /PRNewswire/ — Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the Cyltezo® Pen, a new autoinjector option for Cyltezo (adalimumab-adbm), an FDA-approved Interchangeable biosimilar to Humira® (adalimumab). Initially approved as a pre-filled syringe, Cyltezo is indicated to treat multiple chronic inflammatory diseases. The 40 mg/0.8 mL pre-filled Cyltezo Pen will be available in two-, four- and six-pack options on July 1, 2023.

“The FDA approval of the Cyltezo Pen is great news for patients living with chronic inflammatory diseases who may prefer administering the medication needed to manage their conditions via an autoinjector,” said Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim. “We’re excited to be able to offer the Cyltezo Pen as an additional option to patients at Cyltezo’s launch on July 1.”

The patient-centered design of the pen features a one-button, three-step activation, with 100% drug visibility and a protected needle. The Arthritis Foundation has certified the Cyltezo Pen as an “Ease of Use” product. For more information about the Arthritis Foundation’s “Ease of Use” certification, please visit their website.

About Biosimilars
A biosimilar is a biologic medication that is made by a different company than the one that invented it, 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 receive an interchangeable designation, the FDA generally requires additional data, including a switching study where patients are switched back and forth from the reference product to the biosimilar multiple times.

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:

To learn more about biosimilars and interchangeability please click here: Interchangeable Biosimilars.

INDICATIONS FOR CYLTEZO® (adalimumab-adbm) injection, for subcutaneous use

Rheumatoid Arthritis: Cyltezo is indicated 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. Cyltezo can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

Juvenile Idiopathic Arthritis: Cyltezo is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Cyltezo can be used alone or in combination with methotrexate.

Psoriatic Arthritis: Cyltezo is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Cyltezo can be used alone or in combination with non-biologic DMARDs.

Ankylosing Spondylitis: Cyltezo is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

Crohn’s Disease: Cyltezo 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: Cyltezo 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: Cyltezo 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. Cyltezo should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

Hidradenitis Suppurativa: Cyltezo is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients

IMPORTANT SAFETY INFORMATION FOR CYLTEZO® (adalimumab-adbm) injection, for subcutaneous use



Patients treated with adalimumab products, including Cyltezo, 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 Cyltezo if a patient develops a serious infection or sepsis.

Reported infections include:

Carefully consider the risks and benefits of treatment with Cyltezo prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. 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 Cyltezo, including the possible development of 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. 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 Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6-MP) 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

Congestive Heart Failure




You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit or call 1-800-FDA-1088.

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.

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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.

Posted: May 2023

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