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Classified in: Health
Subject: FDA

U.S. FDA Approves Cyltezo® (adalimumab-adbm) as First Interchangeable Biosimilar with Humira®


RIDGEFIELD, Conn., Oct. 15, 2021 /PRNewswire/ -- Boehringer Ingelheim today announced the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for Cyltezo® (adalimumab-adbm) as the first Interchangeable biosimilar with Humira® (adalimumab). The FDA originally approved Cyltezo® in 2017 for the treatment of multiple chronic inflammatory diseases and this latest approval designates it as Interchangeable across all of these indications.

"We are proud to be the company driving the advancement of biosimilars and delivering the first and only Interchangeable biosimilar with Humira®. It is a true milestone and an important step forward for broader adoption in the U.S. and for patient access to affordable medicines," said Thomas Seck, senior vice president, Medicine and Regulatory Affairs at Boehringer Ingelheim. "The Interchangeability status of Cyltezo® reinforces our goal of expanding overall treatment options and contributing to the quality and sustainability of the U.S. healthcare system."

A biosimilar is a biological 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. An Interchangeable biosimilar must first meet the high FDA standards of a biosimilar. Then, in order to achieve the interchangeable designation, the FDA requires an additional clinical study of multiple substitutions in patients, known as an Interchangeability study. This type of study shows how patients do when they are switched back and forth multiple times from a reference product to the Interchangeable biosimilar candidate. A biosimilar with an Interchangeable designation can be auto-substituted by a pharmacist for the reference product, with individual state laws controlling how and whether physicians will be notified.

"As the first Interchangeable biosimilar of Humira®, Cyltezo® (adalimumab-adbm), represents an important step toward bringing patients more affordable treatment options for complex, and often expensive, biologic reference products," said Martin Alan Menter, MD, chairman of the Division of Dermatology at Baylor University Medical Center. "This is incredibly important for patients, who can be confident that once available, citrate-free Cyltezo® has the same efficacy and safety as the originator medicine with the added benefit of cost savings."

The approval for Interchangeability was supported by positive data from Boehringer Ingelheim's Phase III randomized VOLTAIRE-X clinical trial and marks the first FDA approval for such a study. The VOLTAIRE-X trial studied the effects of multiple switches between Humira® and Cyltezo®. This additional study demonstrated that Cyltezo® is equivalent to Humira® with no meaningful clinical differences in pharmacokinetics, efficacy, immunogenicity, and safety between the switching and continuous treatment groups. The results were presented at the American Academy of Dermatology 2021 conference.

Cyltezo® is not commercially available in the U.S. at this time, but its commercial license will begin on July 1, 2023.

About Boehringer Ingelheim in Biologics and Biosimilars

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 40 biologics to the market ? three in 2020 alone ? in therapeutic areas that include oncology, immunology, and cardiovascular indications. In this way, Boehringer Ingelheim further builds on its commitment to immunology to develop high quality, safe, and effective treatment options for patients with autoimmune diseases. For more information about Boehringer Ingelheim's Biopharma and manufacturing capabilities, please click here: https://www.boehringer-ingelheim.us/biopharma/biosimilars

All public information on our clinical trials is available on: http://clinicaltrials.gov/.

*Humira® is a registered trademark of AbbVie Biotechnology Ltd.

About Cyltezo®

Cyltezo® was approved by the U.S. Food and Drug Administration (FDA) in August 2017 for the treatment of multiple chronic inflammatory diseases including rheumatoid arthritis, psoriasis and Crohn's disease.

Please see full Prescribing Information, including Medication Guide.

IMPORTANT SAFETY INFORMATION FOR CYLTEZO®
WARNING: SERIOUS INFECTIONS and MALIGNANCY

SERIOUS INFECTIONS

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. 

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 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

Autoimmunity

Immunizations

ADVERSE REACTIONS

CL-BI501-100000 CYLTEZO ISI for HCP October 2021

About Boehringer Ingelheim

Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, with around 52,000 employees, we create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2020, Boehringer Ingelheim achieved net sales of around 22.33 billion USD (19.57 billion EUR). Our significant investment of over 4.2 billion USD (3.7 billion EUR) in 2020 (18.9% of net sales) in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies. In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA.

Boehringer Ingelheim is committed to improving lives and strengthening our communities. Please visit www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives.

For more information, please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.

MPR-US-101912

SOURCE Boehringer Ingelheim


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News published on 15 october 2021 at 19:21 and distributed by: