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Boehringer Ingelheim. (7/27/17). "Press Release: Boehringer Ingelheim Starts Clinical Study on Interchangeability between its Adalimumab Biosimilar Candidate and Humira". Ingelheim.

Region Region United States (USA)
Organisations Organisation Boehringer Ingelheim (Group)
  Organisation 2 FDA (US Food and Drug Administration)
  Group United States (govt)
Products Product Cyltezo™ (biosimilar adalimumab-adbm to Humira)
  Product 2 clinical research
Person Person Blanarik, Ivan (Boehringer 201707 SVP + Head Therapeutic Area Biosimilars)
     


> First patient enrolled into VOLTAIRE-X; an interchangeability study designed to assess whether BI 695501 is interchangeable with Humira®1

> First study in the U.S. to investigate an interchangeability designation for an adalimumab biosimilar candidate

> BI 695501 is currently under review by regulatory authorities2


Boehringer Ingelheim announced today that the first patient has been enrolled into its VOLTAIRE-X interchangeability study. The goal of the study is to demonstrate that BI 695501 is interchangeable with the U.S.-marketed formulation of Humira®* 40mg/0.8mL. This is the first study in the U.S. to investigate an interchangeability designation for an adalimumab biosimilar candidate.

The study will compare the pharmacokinetics and clinical outcomes between patients receiving Humira® continuously, versus those who switch repeatedly between Humira® and BI 695501, Boehringer Ingelheim’s adalimumab biosimilar candidate.1 The study will also assess safety, immunogenicity and efficacy.1

“We are pleased that the first patient has now been enrolled in VOLTAIRE-X, and look forward to continued recruitment and patient follow-up,” said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim. “The initiation of this study reinforces our commitment to improving the lives of patients suffering from serious chronic or life-threatening diseases through biosimilars. With biosimilars, we will have the opportunity to expand treatment options while at the same time providing value to the healthcare system.”

The VOLTAIRE-X study (NCT03210259 (link is external))1, is being conducted in 240 patients with moderate-to-severe chronic plaque psoriasis. Results from the study are expected in the second half of 2019.1

BI 695501 has been accepted for regulatory review by the European Medicines Agency and the U.S. Food and Drug Administration.2 Phase III results demonstrating clinical equivalence of BI 695501 to Humira® in people living with rheumatoid arthritis were recently presented at the annual European Congress of Rheumatology.3


About Interchangeability

As per the US Food and Drug Administration, an interchangeable biologic is a biosimilar that produces the same clinical result as its reference product in any given patient.4 Interchangeability is a designation by the FDA that means a biosimilar may be substituted by a pharmacist for the reference product without the intervention of the healthcare provider who wrote the prescription, subject to individual state law.5 More than half of the U.S. have either passed or are considering state laws regarding automatic substitution of biologics.6


About Plaque Psoriasis

Plaque psoriasis is an autoimmune disease characterised by dry, red skin lesions which are covered in silver scales.7 Accounting for approximately 80% of cases it is the most common form of psoriasis.8 Common sites of the disease include elbows, knees, scalp and lower back, but affected areas can appear anywhere on the body.9


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: BI 695501, 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/ (link is external).


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 (link is external).


Intended audiences:

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.


Footnotes

* Humira® is a registered trademark of AbbVie Biotechnolgoy Ltd. and Avastin® is a registered trademark of Genentech, Inc. (USA).


References

1 ClinicalTrials.gov. ‘This trial compares BI 695501 and Humira® in patients with a long-term disease that causes red, scaly patches on the skin (plaque psoriasis). The trial looks at the way the body takes up the drugs and how effective and safe they are (VOLTAIRE-X)’. [Online] Available at: https://clinicaltrials.gov/ct2/show/NCT03210259 [Accessed: July 2017].
2 Kaufman B. M. ‘Biosimilar Update: ACR says FDA draft guidance is promising and biosimilar to Humira (Adalimumab) enters regulatory review’. The Rheumatologist. [Online] Availlable at: http://www.the-rheumatologist.org/article/biosimilar-update-acr-says-fda-draft-guidance-promising-biosimilar-humira-adalimumab-enters-regulatory-review/ [Accessed: July 2017].
3 Cohen S, et al. Similar efficacy and safety of biosimilar candidate BI 695501 and Humira® reference product in patients with moderate to severe active RA: 24 week results from a Phase III clinical study (VOLTAIRE®-RA). Abstract presented at EULAR, Madrid, June 14-17 2017
4 U.S Food & Drug Administration. ‘Information for Healthcare Professionals (Biosimilars)’. [Online] Available at: https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm241719.htm [Accessed: July 2017]
5 U.S Food & Drug Administration. ‘Inforamtion for Consumers (Biosimilars)’. [Online] Available at: https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm241718.htm [Accessed: July 2017]
6 Biosimilars Forum. ‘Frequently Asked Questions’ [Online] Available at: http://www.biosimilarsforum.org/sites/default/files/uploads/biosimilars_faqs_032816opt_0.pdf [Accessed: July 2017]
7 National Psoriasis Foundation, ‘About Psoriasis’. [Online] Availbale at: https://www.psoriasis.org/about-psoriasis [Accessed: July 2017].
8 American Academy of Dermatology, ‘Psoriasis’. [Online] Available at: https://www.aad.org/media/stats/conditions/psoriasis [Accessed: July 2017].
9 NHS Choices, ‘Psoriasis’. [Online] Available at: http://www.nhs.uk/Conditions/Psoriasis/Pages/Introduction.aspx [Accessed: July 2017].


Contact

Dr Julia Knebel
Media Contact
Media & PR
Phone +49 6132 77 2356
Fax +49 6132 77 6601
Binger Strasse 173
55216 Ingelheim am Rhein
GERMANY

   
Record changed: 2017-08-02

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