Boehringer Ingelheim Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved CyltezoTM, a biosimilar to Humira®*, in a pre-filled syringe for the treatment of multiple chronic inflammatory diseases, including:
- moderate to severe active rheumatoid arthritis
- moderate to severe polyarticular juvenile idiopathic arthritis**
- active psoriatic arthritis
- active ankylosing spondylitis (an arthritis that affects the spine)
- moderate to severe active adult Crohn's disease
- moderate to severe active ulcerative colitis
- moderate to severe plaque psoriasis
"CyltezoTM is the first biosimilar from Boehringer Ingelheim to be approved by the FDA and marks an important step towards our goal of providing new and more affordable treatment options to healthcare providers and patients," said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim. "Chronic inflammatory diseases collectively affect 23.5 million people in the U.S., and CyltezoTM has the potential to deliver significant benefits to many of these individuals."
The FDA approval is based on a comprehensive data package comprised of analytical, pharmacological, non-clinical and clinical development studies demonstrating that CyltezoTM is biosimilar to Humira®.
The European Medicines Agency is expected to provide an opinion on the marketing authorization application for our biosimilar candidate in 2017.
CyltezoTM is not commercially available at this time. Boehringer Ingelheim is currently engaged in patent litigation with AbbVie. Boehringer Ingelheim will also seek approval for an auto-injector of CyltezoTM, as another delivery option for patients.
About CyltezoTM (adalimumab-adbm) injection, for subcutaneous use
Rheumatoid Arthritis: CYLTEZO 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: CYLTEZO is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older.
Psoriatic Arthritis: CYLTEZO 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: CYLTEZO is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
Adult Crohn's Disease: CYLTEZO is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy, and reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
Ulcerative Colitis: CYLTEZO is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of CYLTEZO 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.
Please see full Prescribing Information, including Medication Guide.
About Boehringer Ingelheim
Innovative medicines for people and animals have for more than 130 years been what the research-driven pharmaceutical company Boehringer Ingelheim stands for. Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies and to this day remains family-owned. Day by day, some 50,000 employees create value through innovation for the three business areas human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. In 2016, Boehringer Ingelheim achieved net sales of around 15.9 billion euros. With more than three billion euros, R&D expenditure corresponds to 19.6 percent of net sales.
Social responsibility comes naturally to Boehringer Ingelheim. That is why the company is involved in social projects such as the “Making More Health” initiative. Boehringer Ingelheim also actively promotes workforce diversity and benefits from its employees’ different experiences and skills. Furthermore, the focus is on environmental protection and sustainability in everything the company does.
* Humira® is a registered trademark of AbbVie, Inc. and Avastin® is a registered trademark of Genentech, Inc. (USA).
** (Four years of age and older)