Boehringer Ingelheim Receives Positive CHMP Opinion For Adalimumab Biosimilar CYLTEZO

• Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Cyltezo (adalimumab biosimilar) for the treatment of multiple chronic inflammatory diseases
• Recommendation based on extensive analytical, pharmacological, non –clinical & clinical data, which demonstrated similarity of Cyltezo /BI 695501 to Humira
• Positive opinion follows the recent FDA approval of Cyltezo¹

Boehringer Ingelheim recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorisation Application of Cyltezo (adalimumab biosimilar), to treat multiple chronic inflammatory diseases in adults and children. The decision of the European Commission on the approval is expected in the fourth quarter of 2017.

“The recommendation by the CHMP for Cyltezo is an important milestone for Boehringer Ingelheim, bringing us one step closer to providing our first biosimilar to healthcare providers and patients” said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim. “Chronic inflammatory diseases can be incredibly debilitating and we are delighted that Cyltezo has the potential to improve the lives of many of these patients. BI is committed to supporting the long-term potential of biosimilars, which we believe will be a key contributor to the future sustainability of healthcare systems around the world.”

The CHMP has recommended the approval of Cyltezo for multiple chronic inflammatory diseases including, in adults:

• Moderate to severely active rheumatoid arthritis
• Psoriatic arthritis
• Moderate to severely active Crohn's disease
• Severe active ankylosing spondylitis
• Moderate to severely active ulcerative colitis
• Severe axial spondyloarthritis without radiographic evidence of AS
• Moderate to severe chronic plaque psoriasis
• Moderate to severe hidradenitis suppurativa
• Non-infectious intermediate, posterior and panuveitis.

The CHMP also recommends approval of Cyltezo for the treatment of paediatric inflammatory diseases, including moderate to severe Crohn's disease (age six and older), severe chronic plaque psoriasis (age four and older), enthesitis-related arthritis (age six and older) and polyarticular juvenile idiopathic arthritis (age two and older).

The Marketing Authorisation Application (MAA) for Cyltezo was based on a comprehensive data package supporting the biosimilarity of Cyltezo to Humira (adalimumab) based on analytical, pharmacological, non-clinical and clinical data, including results from the pivotal Phase III study VOLTAIRE-RA, which demonstrated clinical equivalence of BI 695501 to the reference product in people with moderate to severely active rheumatoid arthritis. The pivotal phase III study met its primary endpoint showing no clinically meaningful difference in efficacy between BI 695501 and Humira in terms of safety and immunogenicity.²

Cyltezo was approved in the United States (U.S.) by the U.S. Food and Drug Administration (FDA) on August 25th 2017.³ Cyltezo is not commercially available in the US at this time. 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.

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.

Boehringer Ingelheim currently has two biosimilar monoclonal antibodies in late stage development: Cyltezo, adalimumab biosimilar candidate to Humira and BI 695502, bevacizumab biosimilar candidate to Avastin. All public information on our clinical trials is available on: http://clinicaltrials.gov/.

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 per cent 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.

More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.

References

1. Brennan, Zachary. 2017. FDA Approved 6th Biosimilar in US, Second for Humira. Regulatory Affairs Professionals Society. http://www.raps.org/Regulatory-Focus/News/2017/08/28/28340/FDA-Approves-6th-Biosimilar-in-US-Second-for-Humira/. [Accessed: September, 2017]
2. Ramael S, et al. Similar pharmacokinetics, safety and tolerability of the Humira (adalimumab) biosimilar candidate BI 695501 administered subcutaneously via prefilled syringe (PFS) or autoinjector (AI) (VOLTAIRE-AI). Abstract presented at EULAR, Madrid, June 14-17 2017.
3. U.S. Food & Drug Administration. 2017. Drugs@FDA: FDA Approved Drug Products. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761058. [Accessed: September, 2017].