Cyltezo®, adalimumab biosimilar from Boehringer Ingelheim, approved in Europe for the treatment of multiple chronic inflammatory diseases
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.
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
Media + PR
Dr. Julia Knebel
Phone: +49 6132 – 77 95614
Fax: +49 6132 – 77 6601
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
European Commission approves Ipsen’s Cabometyx® (cabozantinib) for the treatment of hepatocellular carcinoma in adults previously treated with sorafenib15.11.2018 09:30 | Tiedote
Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the European Commission (EC) has approved Cabometyx® (cabozantinib) 20, 40, 60 mg as a monotherapy for hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib. This approval allows for the marketing of Cabometyx® (cabozantinib) in this indication in all 28 member states of the European Union, Norway and Iceland. “Today’s EC approval for the use of Cabometyx ® provides a much needed new option for HCC patients. Until now, physicians in Europe had only one approved therapy for the 2 nd line treatment of this aggressive and difficult-to-treat cancer.1,2 We are proud to offer Cabometyx ® as an innovative treatment that has been shown to extend survival in previously treated patients with HCC,” said Harout Semerjian, Chief Commercial Officer, Ipsen. “This new indication reinforces Ipsen’s commitment to improve patients’ lives through the expansion of the clinical benefit of Cabometyx ® i
Mobidiag nostaa viimeisen €4M erän Euroopan investointipankin €15M rahoituksesta15.11.2018 09:30 | Tiedote
Mobidiag Oy, vahvassa kasvuvaiheessa oleva molekyylidiagnostiikkayhtiö, joka taistelee antibioottiresistenssin leviämistä vastaan, ilmoitti tänään, että se on nostanut viimeisen 4 miljoonan euron erän 15 miljoonan euron lainasta, jonka Euroopan investointipankki (EIP) myönsi yhtiölle kolmivuotiseen projektiin heinäkuussa 2016. Laina myönnettiin osana EIP:n ”InnovFin - EU Finance for innovators” -ohjelmaa. Ohjelman tavoitteena on tukea innovatiivisten eurooppalaisten yhtiöiden haastavia korkean teknologian kehityshankkeita mahdollistamalla rahoituksen. Tämä lehdistötiedote sisältää multimediaa. Katso koko julkaisu täällä: https://www.businesswire.com/news/home/20181114005789/fi/ Aiemmin nostettujen EIP:n lainaerien avulla Mobidiag on kehittänyt valmiiksi ja kaupallistanut Novodiag® -molekyylidiagnostiikan järjestelmänsä sekä kaksi suolistoinfektioiden aiheuttajien tunnistamiseen käytettävää testiä (Novodiag® C. difficile ja Novodiag® Bacterial GE+). Viimeisen lainaerän avulla yhtiö nope
Mobidiag Receives Final €4M Tranche of €15M EIB Financing15.11.2018 09:30 | Tiedote
Mobidiag Ltd., a commercial stage molecular diagnostics company addressing the spread of antimicrobial resistance, announced today that it has received the final €4M tranche of a €15M three-year project secured by the Company from the European Investment Bank Group (EIB) in July 2016. The loan was provided as part of “InnovFin – EU Finance for innovators” programme, an EIB initiative aimed at providing innovative and high quality companies in Europe with access to finance. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181114005786/en/ The EIB funding has already enabled Mobidiag to finalize, launch and commercialize its Novodiag® molecular diagnostic system and two assays for detection of gastrointestinal infections (Novodiag® C. difficile and Novodiag® Bacterial GE+). The final tranche will enable the Company to continue growing its product portfolio, accelerate the development of further assays for the Novodiag® system an
Highlights of China’s No. 1 High-Tech Fair CHTF 201815.11.2018 05:00 | Tiedote
The 20th China Hi-Tech Fair (CHTF 2018) is being held from November 14-18 at the Shenzhen Convention and Exhibition Center with the theme “New Development Concept for High Quality Growth.” This year’s CHTF consists of exhibitions, forums, professional meetings, supporting activities, talents exchange meetings and overseas fairs, and features advanced manufacturing, next-generation information technology, AI, life sciences, new materials, new energy, as well as integration of real economy and future industries. Here are some of the highlights of CHTF 2018: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181114005654/en/ International and Belt & Road Pavilion of CHTF (Photo: Business Wire) Themed areas focusing on industry hotspots The IT exhibition will present themed areas like AI, smart manufacturing, smart automotive, sports technology, big data, cloud computing, IoT and blockchain; the environmental exhibition will highlig
MapleStory Prepares for Epic Battle Against the Black Mage in Gathering of Heroes Event15.11.2018 00:00 | Tiedote
MapleStory, the iconic global MMORPG from Nexon America, is bringing the first phase of its long-awaited battle with the sinister villain, the Black Mage. Between November 14 through November 28, players can take part in the “Gathering of Heroes” event to join the Maple Alliance and prepare their armies to soon combat the Black Mage. The Black Mage has long been the main antagonist behind MapleStory. His story originated with the role of bringing balance to Maple World, but turned dark as he realized the only way to save Maple World was to destroy it. Now that his seal has been broken, players will need to work together to defeat the legendary boss. The Gathering of Heroes event adds the Maple Alliance outpost, where players can hone their skills and prepare to level up in preparation of for their battle against the Black Mage, as well as adds various leveling updates. The main goal of the Alliance is to gather “Determination” and power up the holy light in the outpost to be able to fi
SpinalCyte Announces Sustained 12-Month MRI Outcomes After CybroCell™ Injection14.11.2018 23:07 | Tiedote
SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc nucleus using its universal donor product, CybroCell™, today announced that a single injection of modified human dermal fibroblasts (HDFs), resulted in significant improvements of disc height and pain reduction 12 months after injection of the cell therapy for patients with degenerative disc disease (DDD). The trial assessed patients using the Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) and disc height via MRI scans. Using composite scoring, 54% of the treatment arm patients met all three endpoints as compared to only 17% with the placebo (p=0.0003). Over 84% of patients in the treatment group of CybroCell™ or CybroCell™ with platelet rich plasma (PRP) injections had an increase or no change in disc height compared to 25% for the placebo saline injection. Analyzed individually, 83% of spinal discs that were injected with CybroCell™ had an increase or no change in disc he
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