LG G6 review Samsung Galaxy S8 Apple iPhone X Samsung Galaxy Note 8 HTC U 11 Sony Xperia L1
LG G6 review Samsung Galaxy S8 Apple iPhone X Samsung Galaxy Note 8 HTC U 11 Sony Xperia L1
  2017 NEWS APPLE CANON FUJIFILM HTC HUAWEI LG MOTOROLA NIKON NINTENDO NOKIA OLYMPUS PANASONIC PENTAX SAMSUNG SONY  
Apple iPhone
 
     
Powered by True
Counted by OneStat.com
Mark Peters : June 25th 2017 - 18:30 CET

Samsung medicinal products for affordable healthcare


Digital Camera Review Test Appareil Photo Numerique Prueba camara digital Digitale Camera Test Dijital Kamera Incelemeleri Digitalkamera Test Digitalkamera
SamsungSamsung Biopis medicinal products : Samsung Bioepis announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion on Imraldi. Samsung Bioepis is a biopharmaceutical company committed to realizing accessible healthcare for everyone. Imraldi is a biosimilar candidate referencing Humira (adalimumab), for rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis and uveitis. The positive opinion for medicinal product will now be referred to the European Commission which will review and decide on the grant of a marketing authorization for Imraldi.
Samsung Medicinal products

Samsung medicinal products
The Marketing Authorization Application (MAA) for Imraldi was based on data derived from a randomized, double-blind 52-week Phase III study, in which 544 patients with moderate to severe rheumatoid arthritis despite methotrexate (MTX) therapy were randomized to receive either Imraldi or the adalimumab reference product (ADL).

At Week 24, the ACR20 response rate was 72.4% in the Imraldi group versus 72.2% in the ADL group. The safety profile of Imraldi was comparable to ADL up to Week 24. At Week 24, 254 patients receiving ADL were re-randomized in a 1:1 ratio to continue on ADL or switch to Imraldi, and 254 patients receiving SB5 continued to receive SB5.

Up to Week 52, the efficacy, safety and immunogenicity profiles remained comparable between all three treatment groups. There were no treatment emergent issues or clinically relevant immunogenicity precipitated by switching from ADL to Imraldi.

If a marketing authorization is granted by the EC, Imraldi will be commercialized in the European Union by Biogen.

Affordable healthcare

Affordable healthcare
"We welcome the positive recommendation for Imraldi, which brings Samsung a step closer to delivering a lower-cost, high-quality autoimmune treatment option to patients across Europe," said Christopher Hansung Ko, President & CEO of Samsung Bioepis. "Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry's strongest biosimilar pipelines, so that more patients and healthcare systems across Europe will benefit from biosimilars."




   Next  Canon EOS 4K Digital Cinema Cameras
   Previous  New smartphone user interface unveiled by Panasonic
   News by brand:Samsung
   News by category:Mobile health solutions
   News by brand and category:Samsung Mobile health solutions


Android smartphone
Latest Samsung announcements
QuickDrive washing machine test by Samsung
Samsung QuickDrive laundry technology
History of the IFA consumer electronics trade show
Exclusive: Samsung Q6 QLED smart TV series
New Samsung tablet to arrive at IFA
Samsung 360 Round camera unveiled
Samsung's social smartphone camera
IFA 2017: Samsung professional monitors announced
Samsung Mobile Solutions Forum 2017
Samsung Bioepis receives European authorization
Samsung Galaxy Tab Active 2 receives certification
Samsung Home Appliances to feature voice recognition
Samsung LED lighting modules
Samsung mobile education projects
Samsung cordless vacuum cleaners at IFA 2017
 
Latest news headlines
Honor 6C Pro surfaces
Huawei Pay mobile payment service for United States
Full-grain leather iPhone X cases from Dutch vendor
GoPro Fusion 360 degree camera to launch at CES 2018
Apple iPhone X retail box surfaces
Google Pixel 2 certification unveils new details
Samsung refrigerator test results
Huawei trademark confirms Selfie flash for Mate 10
Receive in stock alerts on Twitter
Apple Pay Cash trademark for Asia-Pacific
QuickDrive washing machine test by Samsung
SanDisk memory cards for Nintendo Switch game system
Samsung QuickDrive laundry technology
History of the IFA consumer electronics trade show
Wearable Device Trends by Tractica
   
  5G Accessories Android Galaxy iPhone Rumors Premium smartphones Camera Camera test Nikon SLR Underwater photography   CES CeBIT IFA Photokina PMA