Boehringer Ingelheim’s adalimumab biosimilar candidate shows similar efficacy and safety profile to Humira® in pivotal Phase III study
26.10.2016 12:00 | Business Wire
Boehringer Ingelheim today announced top-line results from the pivotal Phase III clinical study of BI 695501, a biosimilar candidate to U.S.-licensed Humira® and EU approved Humira® (adalimumab). BI 695501 met the clinical study primary efficacy endpoint to establish equivalence with Humira® in patients with active rheumatoid arthritis (RA). The secondary endpoints for efficacy, safety and immunogenicity of BI 695501 vs. Humira®, were also met.
“This milestone paves the way for submitting BI 695501 for regulatory approval in key markets such as the USA and Europe”, said Sandeep Athalye, MD, Vice President and Head, Clinical Development and Medical Affairs Biosimilars, Boehringer Ingelheim. ”With our focus on BI 695501 and other biosimilar candidates, we recognize biosimilars as playing an increasing role in providing patients and doctors with high quality therapeutic options while contributing to the long term sustainability of healthcare systems.”
This Phase III clinical study was a randomized, double-blind, parallel arm, multiple dose, active comparator study1 in 645 patients diagnosed with moderate to severe active rheumatoid arthritis who were treated with methotrexate. Each participant was randomized to receive either BI 695501 or Humira® every two weeks for 48 weeks. The primary objective of this clinical study was to establish statistical equivalence in efficacy between BI 695501 and Humira® in patients with active RA as measured by the proportion of patients meeting ACR20 (American College of Rheumatology 20) criteria at Week 12 and at Week 24 compared to baseline.2
The secondary objectives of this clinical study were to compare other efficacy parameters (DAS28)3, safety and immunogenicity of BI 695501 and Humira®.
Results from this clinical study will be published and presented at future medical congresses.
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/boehringer-ingelheim-s-adalimumab-biosimilar-candidate-shows-similar-efficacy-and
Media + PR
Phone: +49 6132 – 77 2356
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
Lenovo Continues to Gain Momentum in First Quarter FY 2017/1818.8.2017 00:04 | Pressemelding
Behind the strength of its 3-wave strategy, Lenovo’s business transformation continued to gain traction during the first quarter, delivering solid profitability in its core PC and smart devices business, and revenue and profit improvements in targeted growth areas, including the data center and mobile businesses. Fueled by new investments in people and products, Lenovo’s Data Center Group (DCG) introduced the most comprehensive product lineup in its history, with the new ThinkSystem and ThinkAgile portfolio, and continued to build out its end-to-end sales organization. Similarly, Lenovo’s Mobile Business Group launched significant new products led by the Moto Z2 Force, available now on all major U.S. carriers, and ramped up its branding efforts worldwide. “In the first quarter this fiscal year, we had stable performance as we executed our 3-wave strategy with commitment. We
Spirent Tests Wi-Fi Network Performance with O2 at the Coca-Cola London Eye17.8.2017 15:57 | Pressemelding
Spirent Communications plc (LSE:SPT), today announced its Landslide E10 network test platform has been used with O2 to validate the Wi-Fi network performance and capacity at the Coca-Cola London Eye, before the launch of a new smartphone application last month. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170817005758/en/ Spirent Landslide E10 helped O2 validate Wi-Fi performance and capacity at the Coca-Cola London Eye, before the launch of a new smartphone application last month. (Photo: Busines Wire) Merlin Entertainments plc, operator of the London Eye, wanted to measure its Wi-Fi network performance, to ensure its infrastructure could provide an excellent experience for users of the new app, which puts increased demands on the Wi-Fi network. “The London Eye is a global attractio
Watch BizWireTV: A Camera You Can Wear and Krispy Kreme’s Famous Donuts Get Eclipsed with Chocolate17.8.2017 12:08 | Pressemelding
On BizWireTV, catch some Quick Biz Hits and see the latest in Star Power. Also see what’s happening in the startup world with the Accelerator Report, featuring the VC Watch and this week’s Startup Standout. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170817005305/en/ BizWireTV is hosted by Jordyn Rolling (Photo: Business Wire Now you can watch BizWireTV, and the latest breakthroughs in tech from the biggest brands, on any screen you want by downloading the new app through the Apple TV and iPhone App Store and Google Play for Android devices. Top of the Wire Introducing FrontRow: the camera re-invented. Watch BizWireTV to see more disruptors as well as the top 5 trending stories of the week! A core c
PsiOxus Therapeutics Announce Two New Board Appointments: New Board Appointments Strengthen Company’s US Presence17.8.2017 07:00 | Pressemelding
PsiOxus Therapeutics, Ltd. (PsiOxus) today announced the appointment of Charles Rowland and Duncan Higgons to the Board of Directors as part of an ongoing drive to expand in the US. Charles Rowland was most recently the President and Chief Executive Officer (CEO) of Aurinia Pharmaceuticals, a clinical stage pharmaceutical company focused on the global lupus nephritis market. Prior to this, he served as the Vice President and Chief Financial Officer (CFO) of ViroPharma, during which time the company grew into a global biopharmaceutical business with $500 million in annual revenues until it was acquired by Shire plc for $4.2 billion. Before joining ViroPharma, Mr. Rowland was executive Vice President, CFO, and interim co-CEO, for Endo Pharmaceuticals. In his earlier career, Charles held finance and operational positions at Biovail Pharmaceuticals, Breakaway Technologies, Pharmacia
Smarsh Adds Voice Archiving Offering with Acquisition of London-Based Cognia17.8.2017 06:59 | Pressemelding
Smarsh®, providing information archiving solutions for compliance, e-discovery and risk management, has completed the acquisition of Cognia, a worldwide leader in cloud-based voice archiving, audio search and analytics. Smarsh will leverage Cognia’s intellectual property and development resources to offer its global customer base enhanced capabilities around mobile and fixed-line voice communication – alongside a market-leading range of electronic communications – within The Archiving Platform. The acquisition will expand the existing presence of Smarsh in Europe and is central to its MiFID II compliance solution for financial firms. In addition to capturing incoming and outgoing communication from fixed-line recording solutions, Cognia uniquely captures voice content directly from leading mobile carriers. Carrier-direct capture is the most reliable and automated method for capt
Schlumberger Announces Third-Quarter 2017 Results Conference Call16.8.2017 21:23 | Pressemelding
Schlumberger Limited (NYSE:SLB) will hold a conference call on October 20, 2017 to discuss the results for the third quarter ending September 30, 2017. The conference call is scheduled to begin at 8:30 am US Eastern time and a press release regarding the results will be issued at 7:00 am US Eastern time. To access the conference call, listeners should contact the Conference Call Operator at +1 (800) 288-8967 within North America or +1 (612) 333-4911 outside of North America approximately 10 minutes prior to the start of the call, and ask for the “Schlumberger Earnings Conference Call.” A webcast of the conference call will be broadcast simultaneously at www.slb.com/irwebcast on a listen-only basis. Listeners should log in 15 minutes prior to the start of the call to test their browsers and register for the webcast. Following the end of the conference call,
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom