Business Wire

Boehringer Ingelheim receives positive CHMP opinion for adalimumab biosimilar CYLTEZO®

Del

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.

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/positive-chmp-opinion-adalimumab-biosimilar-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

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

The Listing of Money Trade Coin on Cryptocurrency Exchange and the Rising Promise of a New Era in Dubai21.9.2017 17:45Pressemelding

MONEY TRADE COIN, the new age cryptocurrency, dazzled its investors’ expectations by listing on NovaExchange. Immediate trading began post the launch by Money Trade Coin’s founder and CEO, Mr. Amit Lakhanpal and H.E. Sheikh Saqer Al Nahyan. The listing event held on September 17 at Burj Al Arab was witnessed by a list of 40 VIP businessmen including H.E. Sheikh Jumaa Al Maktoum, Mr. Faisal Almaazmi, his principal advisor and director of Greenland Capital Properties, Mr. Charles Said Kiwan founder of MVP Tech and Mr. Khaled Abdulla, Head of Communications MENA at Barclays PLC. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170921006013/en/ Amit Lakhanpal greets H.E. Sheikh Saqer Al Nahyan (Photo: AETOS Wire) Money Trade Coin, the propagator of the “Cryptocurrency correct knowledge” l

Triaconta Announces a New Safe Way to Invest in Cryptocurrencies21.9.2017 16:18Pressemelding

Triaconta wants to minimize the risks of investing in cryptocurrencies with Combicoin to make the cryptocurrency market accessible for a larger audience. CombiCoin is 100% asset backed by the top 30 cryptocurrencies with the highest market cap. Because of this the CombiCoin will not suddenly plunge and investors will have less risks when there are major fluctuations. There are over 1000 cryptocurrencies on the market and together they represent a value of 130 billion USD. However, all these coins are very volatile. For example, the value of bitcoin grew from 1000 to 4000 USD within six months. The value of Ethereum, the second largest cryptocurrency, rose from 150 to 400 USD within 6 months but plunged to 150 USD 4 weeks later. In the first six months of 2017 the top 30 of cryptocurrencies grew with 1200 percent. The value of CombiCoin is determined for 3.3

TIP Trailer Services Announces the Successful Refinancing of its ABS program21.9.2017 15:16Pressemelding

On 21 September 2017, TIP Trailer Services announced that it had successfully refinanced its Asset Backed Securitisation (ABS) program. The Pan-European program was originally established in 2014 and is a securitisation structure common under Dutch law for operating leases. The new program will run until March 2019. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170921005815/en/ At the official signing of the TIP ABS refinancing were: From left to right: Jorrit Achterberg (Legal Counsel, TIP Trailer Services), Patrick Vergouwen (International Investor Relations Manager, TIP Trailer Services), Bart de Boo (Director, Asset Based Finance, Rabobank), Gert Huizing (Quality Assurance Manager Capital Market Services, Intertrust), Leo van der Sman (Legal Counsel, Intertrust) (Photo: Business Wire) “The extra funding and improved co

Tohatsu, Major Outboard Manufacturer, to Launch Global Brand Campaign Targeting Millennial Generation Boat Users21.9.2017 14:30Pressemelding

On September 21, 2017, Tohatsu Corporation (headquartered in Tokyo, Japan; hereinafter "TOHATSU") announced the outline of its global brand campaign at the 57th Genoa International Boat Show held in Genova, Italy. TOHATSU’s global brand campaign based on a new branding strategy will be deployed at boat shows around the world, starting from the Genoa International Boat Show in September 2017. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170921005018/en/ Feel the Wind (Photo: Business Wire) The campaign sets “SMARTS” millennials as its core target, revealing TOHATSU’s new brand logo, “Blue Wings” and its unique “Simpliq™ Technology” The feature of the new branding strategy is its target demographic called “SMARTS”, millennial boat owners (born between 1977 and 199

Sigma Systems Chief Technology Officer to Address CSPs at Futurecom 201721.9.2017 14:00Pressemelding

Sigma Systems, the global leader in catalog-driven software, has today announced that its Chief Technology Officer, Catherine Michel, will be speaking at Futurecom 2017 – the largest ICT event in Latin America. Catherine will address communications service providers (CSPs) and industry professionals at the Sao Paulo event on what’s driving the digitalization mandate for operators. Ahead of her presentation, Catherine commented: “The digitalization of the CSP is about transforming business operations, based on a thorough understanding of customer needs, behaviours and experiences. This requires a shift in corporate culture, and many CSPs are not making the changes necessary to embrace digital innovation and become market leading digital service providers. To deliver on a digital transformation, operators must embrace digital innovation and enable the rapid launch a

Encanto Potash Corp Secures CAD $100 Million Capital Commitment from GEM Global21.9.2017 13:00Pressemelding

Encanto Potash Corp. ("Encanto" or the "Company") the TSX-V listed Potash development; Mining and Operating company (TSX-V: EPO) is pleased to announce that it has secured a commitment for a CAD $100 million funding facility. Under the funding agreement signed 15th September, 2017 (the "Agreement"), GEM Investments America, LLC and GEM Global Yield LLC SCS undertake to invest up to CAD $100,000,000 over the next three years. The proceeds will be used to commence the engineering and design phase of the mine in anticipation of a shovel-ready construction date of September 2019. Under a joint venture agreement with Muskowekwan Resources Ltd and Chief Reginald Bellerose of the First Nation’s Muskowekwan tribe, Encanto has secured the mineral rights for the mine and completed preliminary studies. In the interim, proceeds will also be used for the procurement an

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

Besøk vårt presserom