Business Wire

Boehringer Ingelheim starts clinical study on interchangeability between its adalimumab biosimilar candidate and HUMIRA®

Del

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)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

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.

For references and notes to editors, please visit: http://www.boehringer-ingelheim.com/press-release/interchangeability-study-bi-695501-vs-humira

Contact information

Boehringer Ingelheim
Corporate Communications
Media + PR
Dr. Julia Knebel
Phone: +49 6132 – 77 95614
Fax: +49 6132 – 77 6601
Email: press@boehringer-ingelheim.com
www.boehringer-ingelheim.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

ABB and City of Davos Pave the Way to Sustainable Mobility Through E-Vehicle Innovation22.1.2018 15:41Pressemelding

For this year’s annual World Economic Forum (January 23–26, 2018), the city of Davos and ABB have teamed up in a long-term partnership to provide e-infrastructure for public and private transportation. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180122006126/en/ ABB flash-charging station in Davos (Photo: Business Wire) Davos residents and WEF guests can experience the pioneering TOSA bus for themselves. The award-winning TOSA bus, developed by ABB in Switzerland, is already in use in Geneva and will soon be implemented in the French city of Nantes. It can recharge its battery in just 20 seconds as passengers board and disembark. In Davos, it will operate on the busy Line 1, running from the tourist center to the hospital. This is the first time TOSA technology is being used in an Alpine region. The idea is to run the system under extreme winter weather conditions; ABB and its project partners expect to gain valuable insig

Calvin Klein, Inc. Announces the Spring/Summer 2018 Calvin Klein Underwear and Calvin Klein Jeans Global Advertising Campaign22.1.2018 14:00Pressemelding

Calvin Klein, Inc., a wholly owned subsidiary of PVH Corp. [NYSE:PVH], today announced its new CALVIN KLEIN UNDERWEAR and CALVIN KLEIN JEANS global multi-media advertising campaign. The campaign represents the latest iteration of the evolution in the CALVIN KLEIN brand’s globally recognized #MYCALVINS call to action: Our Family. #MYCALVINS. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180122005732/en/ CALVIN KLEIN, INC. ANNOUNCES THE SPRING/SUMMER 2018 Campaign Led by Kim Kardashian West, Khloé Kardashian, Kourtney Kardashian, Kendall Jenner and Kylie Jenner Shot by photographer Willy Vanderperre, the latest chapter of this new campaign features sisters Kim Kardashian West, Khloé Kardashian, Kourtney Kardashian, Kendall Jenner and Kylie Jenner. The siblings are featured wearing styles of CALVIN KLEIN UNDERWEAR that are available in stores and online now, including CALVIN KLEIN Modern Cotton and the new CALVIN KLEIN Body ran

Ferring enters into worldwide OmniAb® platform license agreement with Ligand22.1.2018 14:00Pressemelding

Ferring Pharmaceuticals announced today that it has entered into a worldwide license agreement with Ligand Pharmaceuticals to use Ligand’s OmniAb platform® to discover new human monoclonal antibodies for a range of indications. Under the agreement, Ferring will use OmniAb to accelerate development solutions for unmet patient needs in reproductive medicine and women’s health, urology and gastroenterology. “Antibody-based therapies improve the quality of life and care for patients with a wide range of conditions but have not been fully investigated, in particular in the area of reproductive medicine and women’s health,” said Armin Metzger, Senior Vice President, Head of Global Pharmaceutical Research and Development, Ferring Pharmaceuticals. “This agreement expands Ferring’s growing capabilities in biologics and broadens our historical focus on peptides, opening up significant opportunities for discoveries that will help patients to live better lives.” Ligand's OmniAb® platforms produce

European Commission Approves ADCETRIS® (brentuximab vedotin) for CD30-Positive Cutaneous T-Cell Lymphoma after One Prior Systemic Therapy– Providing an Innovative Treatment Option to Patients22.1.2018 13:00Pressemelding

Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Commission (EC) extended the current conditional marketing authorization of ADCETRIS® (brentuximab vedotin) and approved ADCETRIS for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. ADCETRIS is an antibody-drug conjugate (ADC) directed at CD30, which is expressed on skin lesions in approximately 50 percent of patients with CTCL. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on November 9, 2017. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180122005037/en/ “CTCL is a subtype of non-Hodgkin lymphoma that primarily involves the skin; it typically presents with red, scaly patches or thickened plaques of skin that often mimics eczema or psoriasis and can have a substantial impact on patients’ self-esteem. There a

Hilton Led Hospitality Industry in Customer Innovations and Recorded Best Ever Growth in 201722.1.2018 13:00Pressemelding

In 2017, Hilton (NYSE: HLT) achieved record-setting growth, unveiled industry-leading innovations, and introduced new benefits for guests and Team Members. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180122005292/en/ Hilton Led Hospitality Industry in Customer Innovations and Recorded Best Ever Growth in 2017 (Graphic: Business Wire) 2017 was a year of industry firsts, including the launch of Five Feet To Fitness, Hilton Honors loyalty program partnership with Amazon, Tapestry Collection by Hilton, and workplace innovations that received international recognition. It was also the year that Hilton introduced a ground-breaking concept – Connected Room – the first truly mobile-centric hotel room that will let guests personalize and control their stays from the award-winning Hilton Honors smartphone app. “Last year was another pioneering year for our team around the world, with the launch of new technologies, brands, and partn

Ingersoll Rand Announces Acquisition of ICS Group Holdings Limited, a Leading European Temperature Control and HVAC Solutions Provider22.1.2018 11:30Pressemelding

Ingersoll-Rand plc (NYSE:IR), a world leader in creating comfortable, sustainable and efficient environments, today announced the acquisition of United Kingdom-based ICS Group Holdings Limited (ICS Cool Energy). ICS Cool Energy will be part of the company’s Commercial Heating, Ventilation and Air Conditioning (HVAC) business. ICS Cool Energy is a privately owned temperature control and HVAC solutions and services company that specializes in temporary rental of energy efficient chillers for commercial and industrial buildings across Europe. It also sells, permanently installs and services high performance temperature control systems for all types of industrial processes. “ICS Cool Energy is a leader in the high margin rental services business with a reputation for strong customer service, helping building owners enhance productivity and reduce environmental impact,” said Dave Regnery, executive vice president of Ingersoll Rand. “This acquisition is a strong fit with our Trane business,

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom