Boehringer Ingelheim receives positive CHMP opinion for adalimumab biosimilar CYLTEZO®
Boehringer Ingelheim today 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 U.S. at this time. 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/press-release/positive-chmp-opinion-adalimumab-biosimilar-cyltezo
Media + PR
Dr. Julia Knebel
Phone: +49 6132 – 77 95614
Fax: +49 6132 – 77 6601
Om Business Wire
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
Cancer Patients, Survivors, Supporters and Caregivers Undertake UAE's First Relay for Life19.11.2017 16:31 | Pressemelding
Sharjah, the third largest of the United Arab Emirate’s seven emirates, was the host for the MENA region’s first ever ‘Global Relay for Life,’ (RFL) a 24-hour walkathon that is the biggest fundraising event for cancer in the world. Conducted in conjunction with the American Cancer Society, the event was organised by Friends of Cancer Patients (FoCP), a non-profit organisation that supports cancer patients and their families. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171119005048/en/ During MENA's first Global Relay For Life walkathon - Source: Friends of Cancer Patients Taking place November 17-18 at the American University Sharjah, the inaugural UAE RFL saw more than 2,000 relayers participating in the overnight event, with a large number of individuals and institutions involved including 52 sch
New Data Show Benefit of Tagrisso in Patients with EGFR-mutated Non-small Cell Lung Cancer and Central Nervous System Metastases18.11.2017 23:00 | Pressemelding
AstraZeneca today presented new data from a subgroup analysis of the Phase III FLAURA trial, which explored osimertinib as 1st-line therapy in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). Results presented at the ESMO Asia 2017 Congress in Singapore showed that patients with central nervous system (CNS) metastases at baseline had a higher objective response rate with their brain metastasis and suggest a lower risk of CNS progression when treated with osimertinib, a third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI), versus current standard-of-care EGFR-TKIs (erlotinib or gefitinib) [Abstract LBA5].1 The analysis included patients with ≥1 measurable and/or non-measurable CNS lesion present on baseline scan (as assessed by blinded independent central review), accounting for 23
New England Journal of Medicine Publishes Results of Phase III FLAURA Trial in the 1st-Line Treatment of EGFR-mutated Non-small Cell Lung Cancer18.11.2017 18:20 | Pressemelding
AstraZeneca today announced that the New England Journal of Medicine has published the positive results from the Phase III FLAURA trial which provide data for Tagrisso’s (osimertinib) use in the 1st-line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).1 The trial showed a statistically significant, clinically meaningful progression-free survival (PFS) advantage for osimertinib, a third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI), compared with current 1st-line EGFR-TKIs, erlotinib or gefitinib.1 This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171118005044/en/ Dr. Suresh S. Ramalingam, Principal Investigator of the FLAURA trial, from the Winship Cancer Institute
Much-Anticipated CHTF 2017 Top 10 Products Are Unveiled18.11.2017 09:11 | Pressemelding
The 19th China Hi-Tech Fair (CHTF 2017), with the theme of “Innovation-Driven Development and Supply Quality Upgrade”, is taking place from November 16 to 21 at Shenzhen Convention and Exhibition Center. On the afternoon of November 10, the CHTF 2017 Top 10 Products were unveiled at the awards ceremony by Mr. Gao Zimin, Vice Mayor of Shenzhen City. A total of 322 entries competed for the honor Top 10 Products, and the voting lasted nearly 3 months. 60 candidate products in the fields of new energy, 3D print, flexible display, life sciences, unmanned vehicles and AI were shortlisted by the organizer, experts and media representatives and went for open voting online. The final Top 10 Products all represent the most advanced technologies in their respective sectors: the water-making device that can make water out of air, the smart sportswear that can monitor heartbeat and other
Madison Realty Capital Provides $64.0 Million Construction Financing for 200 Kent Avenue Development in Williamsburg, Brooklyn17.11.2017 16:20 | Pressemelding
Madison Realty Capital (MRC) announced the closing of a $64.0 million construction loan for 200 Kent Avenue, a 117,326 square foot mixed-use development located in Williamsburg, Brooklyn. The retail portion of the property, which will include over 600 feet of frontage, will be anchored by a popular national grocery chain. Overall, the project will offer 50,101 square feet of retail space, 22,055 square feet of office and restaurant space, and 45,170 square feet of parking. “We continue to establish MRC as the one-stop shop for financing transitional real estate, including ground-up development deals like 200 Kent Avenue,” said Josh Zegen, Co-Founder and Managing Principal of MRC. “In this case, we’re working with a repeat MRC borrower who understands our ability to execute efficiently, given our firm’s up-to-the minute knowledge of local market conditions and non-bureaucratic approach to
Ncardia Announces Completion of €10.5M Investment Round17.11.2017 12:31 | Pressemelding
Ncardia, an emerging drug discovery and development stem cell technology company whose mission is to deliver cardiac and neural solutions based on its best-in-class human induced pluripotent stem cell (iPSC)-derived technology, today announced the completion of a €10.5 million series B financing round. The round was led by Épimède, a Belgium venture capital firm. Ncardia is a privately-held company with operations in Europe and the US, that produces and commercializes high-quality, fully-functional human iPSC-derived cardiovascular and neuronal cell types. Using its cell products, Ncardia develops and commercializes assay services for drug safety and efficacy testing. Additionally the company has built up a strong portfolio of patents covering the use of stem cell models for these applications. Stefan Braam, CEO of Ncardia, commented: “At Ncardia, important progress h
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom