Business Wire

Cyltezo®, adalimumab biosimilar from Boehringer Ingelheim, approved in Europe for the treatment of multiple chronic inflammatory diseases

Jaa

Boehringer Ingelheim today announced that the European Commission has granted marketing authorisation for Cyltezo® a biosimilar to Humira® for the treatment of multiple chronic inflammatory diseases in adults and children.*

“Cyltezo® is the first biosimilar from Boehringer Ingelheim approved in Europe, and marks a significant step forward for us in offering effective, and more affordable treatment options for patients with chronic inflammatory diseases,” said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim. “Boehringer Ingelheim has been an industry leader in the production of biologics for 35 years, and we are delighted to have applied this expertise to the development of Cyltezo®. We believe biosimilars will be a key contributor to the future sustainability of healthcare systems around the world.”

Cyltezo® has been approved for the treatment of multiple chronic inflammatory diseases in adults, including*:

  • Moderate to severely active rheumatoid arthritis
  • Psoriatic arthritis
  • Moderate to severely active Crohn's disease
  • Severe active ankylosing spondylitis (AS)
  • 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.

Cyltezo® has also been granted marketing authorisation 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 of Cyltezo® was based on a comprehensive data package supporting the biosimilarity of Cyltezo® to Humira® comprising analytical, pharmacological, non-clinical and clinical data.

This included results from the pivotal Phase III study VOLTAIRE®-RA, which demonstrated clinical equivalence in efficacy of BI 695501 to the reference product in patients with moderate to severely active rheumatoid arthritis by meeting its primary endpoint. Additionally the study showed no clinically meaningful differences between BI 695501 and Humira® in terms of safety and immunogenicity.3

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Cyltezo® on September 14th, 20171 and on August 25th, 2017, Cyltezo® was approved by the U.S. Food and Drug Administration (FDA) in the United States (U.S.). 2

Cyltezo® is not commercially available in Europe or the U.S. at this time. In any event Boehringer Ingelheim does not intend to launch Cyltezo® in the EU before expiration of the respective SPC for adalimumab in October 2018. Boehringer Ingelheim is currently engaged in patent litigation with AbbVie in the U.S.

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/Marketing-Authorisation-granted-for-Cyltezo

Contact information

Media Contact
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

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Hilton Launches New Brand, Signia Hilton, Delivering Sophisticated Travel While Reimagining Meetings and Events22.2.2019 20:00:00Tiedote

Hilton (NYSE: HLT) today announced the launch of Signia Hilton, its dynamic, new meetings-and-events-focused brand. The portfolio of hotels is setting out to transform the industry for meeting professionals and sophisticated business travelers by infusing state-of-the-art technology and design into every aspect of the guest experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190222005071/en/ The brand further reinforces Hilton’s commitment to innovation that meets the evolving needs of today’s travelers and will bring premium experiences to top urban and resort destinations around the world. “In our 100th year of hospitality, we are more focused than ever on providing exceptional experiences to all of our guests – and that includes evolving those experiences to meet their changing needs,” said Christopher J. Nassetta, president and CEO, Hilton. “We are proud to launch Signia Hilton, which exemplifies our innovative sp

Axonics® Granted Expanded CE Mark Label; First and Only Sacral Neuromodulation System Approved for Use with Full-Body MRI Scans22.2.2019 19:30:00Tiedote

Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, announced today that it has received CE mark approval for 1.5T and 3T full-body magnetic resonance imaging (“MRI”) conditional labeling for the Axonics r-SNM® System. The Axonics r-SNM System is the only implantable SNM system that has received full-body MRI conditional labeling for sale in Europe1. Raymond W. Cohen, Chief Executive Officer of Axonics, said, “Without this labeling, any patient requiring an MRI scan on any body part below the head must have their neurostimulator surgically explanted prior to the MRI scan, resulting in an additional surgery for the patient and additional costs to patients and the healthcare system. This authorization of full-body MRI scans in Europe is another important milestone for Axonics, differentiating our te

Fantastec Joins Forces with Arsenal FC Launching Official Blockchain Collectibles App22.2.2019 17:30:00Tiedote

Fantastec announced today its first football licensing agreement with Premier League club Arsenal FC for a new blockchain authenticated collectibles app called Fantastec SWAP. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190222005277/en/ Arsenal players appear on Fantastec SWAP in official licensing deal (Graphic: Business Wire) London-based Fantastec is a leading sports fan technology innovator, and its blockchain based ‘SWAP’ app will have broad appeal to global sports fans, gamers and sports card collectors alike. Fantastec SWAP unlocks unique and authentic club content through the app, like player autographs and exclusive footage. With its innovative blockchain technology, fans around the world can now discover, collect and swap officially licensed club collectibles with other fans with complete trust. “Fantastec SWAP is a game-changer for international football fans as well the sports collectibles industry,” commented

Volkswagen Protects Virtual Key Sharing App with Trustonic Application Protection22.2.2019 16:42:00Tiedote

Volkswagen is working with mobile cyber security leader Trustonic to enable customers to use smartphones to access their vehicles, and to securely share their digital car keys to grant access to others via a smartphone app. Volkswagen is using the Trustonic Application Protection (TAP) platform to secure the mobile app and ensure that sensitive information and key transfer requests are securely displayed to, and approved by, a real authenticated user on a trusted device and not by hackers or malware simulating a user or device. “The smartphone is becoming the vehicle key of the future and our We Connect service is the interface for this today in the new Volkswagen Passat,” comments Alf Pollex, Head of Infotainment and Connected Car at Volkswagen AG. “The user installs the We Connect app on their smartphone which is then authorized via the infotainment system with a Transaction Number. The Mobile Key will be compatible with Android-based Samsung devices. No mobile network connection is

Mundipharma EDO GmbH: US FDA grants Orphan Drug Designation for etoposide toniribate in relapsed/refractory biliary tract cancer22.2.2019 16:30:00Tiedote

Mundipharma EDO GmbH, part of the Mundipharma network of independent associated companies, and Imbrium Therapeutics L.P., an operating subsidiary of Purdue Pharma L.P., today announced that the US FDA has granted Orphan Drug Designation (ODD) to etoposide toniribate for the treatment of relapsed/refractory biliary tract cancer, also known as cholangiocarcinoma.3 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190222005126/en/ Biliary tract cancer is a rare tumour with approximately 8,000 patients diagnosed in the US every year and 10,571 in Europe.4,5 The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. Radical surgery is the only curative treatment for biliary tract cancer but, in most cases, the cancer is inoperable. Patients who fail first-line chemotherapy have limited treatment options and the standard of

Lenovo Data Center Group Delivers Broad Edge Computing Portfolio, Expands Investments in IoT22.2.2019 16:13:00Tiedote

Next week at MWC Barcelona, Lenovo Data Center Group (DCG) will showcase continued investments in its solutions supporting IoT and edge computing as part of its IoT growth plan over the next few years. Building on the momentum of its fifth consecutive quarter of profit growth, Lenovo DCG is building a portfolio that takes infrastructure to where the data is, whether that be in the traditional data center, in the cloud or increasingly, at the edge. Today, around 10 percent of enterprise-generated data is created and processed outside a traditional centralized data center or cloud. By 2022, Gartner predicts this figure will reach 75 percent. This migration is driving increased concerns around data privacy, security and regulations coupled with challenges of latency, bandwidth and downtime. Lenovo is addressing these challenges by creating a broad portfolio of edge computing offerings that address the different ways that customers want to deploy edge computing solutions for IoT use cases.

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme