Efficacy and safety maintained in patients who switched from Humira® to biosimilar Cyltezo®

- 48-week Phase III data showed Cyltezo and Humira have similar efficacy, safety and immunogenicity in people with rheumatoid arthritis

- Patients who switched at week 24 from Humira to Cyltezo showed no difference to continuous Humira usage

- Data will be presented at the American College of Rheumatology / Association of Rheumatology Health Professionals Annual Meeting

RIDGEFIELD, CT, USA I November 6, 2017 I Boehringer Ingelheim today announced one-year data from VOLTAIRE®-RA, a pivotal Phase III clinical trial comparing Cyltezo® (adalimumab-adbm) and reference product Humira®*. The 48-week data showed that Cyltezo is equivalent, with no clinically meaningful differences in efficacy, safety and immunogenicity to Humira in people with moderately-to-severely active rheumatoid arthritis (RA), including in patients who switched from Humira to Cyltezo at week 24.

"These data are an important addition to the robust body of evidence demonstrating Cyltezo is biosimilar to Humira," said Karsten Kissel, MD, head of global medical affairs biosimilars at Boehringer Ingelheim. "Biosimilars have potential cost benefits to the healthcare system and support affordable access to important biologic medicines for patients living with chronic inflammatory diseases like RA."

"In addition to the 48-week efficacy results, the adalimumab biosimilar Cyltezo showed equivalent safety and immunogenicity to Humira," said Stanley B. Cohen, MD, Metroplex Clinical Research Center, Presbyterian Hospital, Dallas, Texas. "Consistent results were also demonstrated when patients were switched to Cyltezo from the reference product."

These data will be presented at the American College of Rheumatology / Association of Rheumatology Health Professionals Annual Meeting in San Diego, California.

About the VOLTAIRE® Clinical Trial Program
The VOLTAIRE® clinical trial program comprises a number of studies aiming to demonstrate that Cyltezo is biosimilar to Humira across multiple indications. 

In the VOLTAIRE-RA study (NCT02137226), 645 patients aged between 18 and 80 years with moderately-to-severely active RA on stable treatment with methotrexate were randomized to receive Humira or Cyltezo at 40 mg every two weeks for 48 weeks. The primary objective of this clinical study was to assess equivalence in efficacy between Cyltezo and Humira in patients with active RA as measured by the proportion of patients meeting ACR20** (American College of Rheumatology 20) criteria at Week 12 and 24 compared to baseline.  At week 24, patients receiving Humira were re-randomized to switch to Cyltezo or continue on Humira until week 48 (n=148). Other objectives of this clinical study were to compare other efficacy parameters (DAS28), safety and immunogenicity of Cyltezo and Humira.

The VOLTAIRE clinical development program also includes studies in plaque psoriasis and Crohn's disease:

  • VOLTAIRE-X, an interchangeability study with Cyltezo and the U.S.-marketed formulation of Humira, 40mg/0.8mL.
  • VOLTAIRE-PSO, a Phase IIIb study comparing the efficacy, safety and immunogenicity of Cyltezo versus Humira in patients with moderate to severe chronic plaque psoriasis.
  • VOLTAIRE-CD, a Phase IIIb study comparing efficacy, endoscopic improvement, safety, and immunogenicity of Cyltezo versus Humira in patients with active Crohn's disease.
  • VOLTAIRE-AI, a study assessing an auto-injector presentation.

Cyltezo is not commercially available. Boehringer Ingelheim is currently engaged in patent litigation with AbbVie in the U.S.

About Boehringer Ingelheim in Biologics and Biosimilars
Boehringer Ingelheim is one of the largest producers of biologic medicines in the world. As a pioneer in biologics with more than 35 years of experience, the company has manufactured more than 25 biologic medicines for global markets. This includes monoclonal antibodies in immunology and oncology, interferons, and other targeted medicines that are routinely used to treat many patients across a broad range of therapeutic areas. For more information about Boehringer Ingelheim's Biopharma and manufacturing capabilities, please click here https://www.boehringer-ingelheim.us/biopharma/biosimilars

Boehringer Ingelheim further builds on its commitment to immunology and oncology to develop biosimilars as high quality, safe, and effective treatment options to patients with autoimmune diseases and cancer. In addition to Cyltezo® (adalimumab-adbm), Boehringer Ingelheim currently has BI 695502, a bevacizumab biosimilar candidate to Avastin®* in late stage development.. All public information on our clinical trials is available on: http://clinicaltrials.gov/.

About Cyltezo® (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.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families.  Our employees create and engage in programs that strengthen our communities. Please visit our website to learn more about how we make more health for more people through our Corporate Social Responsibility initiatives.

In 2016, Boehringer Ingelheim achieved net sales of about $17.6 billion (15.9 billion euros). R&D expenditure corresponds to 19.6 percent of its net sales.

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

SOURCE: Boehringer Ingelheim Pharmaceuticals

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