Navigation Links
Coherus Announces CHS-0214 (Proposed Etanercept Biosimilar) Meets Primary Endpoint In Pivotal Pharmacokinetic Clinical Study
Date:10/28/2013

REDWOOD CITY, Calif., Oct. 28, 2013 /PRNewswire/ -- Coherus Biosciences, Inc. today announced that its proposed etanercept biosimilar molecule, CHS-0214, an investigational drug, met the primary endpoint of clinical pharmacokinetic (PK) similarity to Enbrel® in a confirmatory clinical study in healthy subjects meeting US, EU, and Japanese regulatory requirements for clinical PK similarity. 

Coherus recently announced an agreement with Baxter International, Inc. to develop and commercialize a biosimilar of the etanercept molecule for Europe, Canada, Brazil, and other markets.  The company has an existing development collaboration with Daiichi Sankyo in Japan.

The two-period, cross-over study met the study acceptance criteria for clinical PK similarity on all three required endpoints: maximum serum concentration (Cmax), area under the time-concentration curve from first to last time point measured (AUC0-t), and area under the time-concentration curve from first time point to infinity (AUC0-inf).  The geometric mean ratios were 98% of CHS-0214 to Enbrel® and were fully within the pre-specified regulatory bounds for the 90% confidence interval for Cmax, AUC0-t, and AUC0-inf.

"This confirmatory clinical PK study is one of two clinical studies required for filing a biosimilar marketing application across most regulatory jurisdictions.  We are pleased to have had such robust results, and in the very near future, we plan to start the second required pivotal study to demonstrate similar safety and efficacy to support eventual regulatory approval and licensure," said Barbara Finck, MD, Chief Medical Officer of Coherus.


'/>"/>

SOURCE Coherus BioSciences
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Valeant Pharmaceuticals Announces Settlement Agreement With Anacor
2. Regulus Announces Significant Progress in Strategic Alliance with AstraZeneca and Selection of a New Pre-Clinically Validated microRNA Oncology Target
3. The Society of Pharmaceutical and Biotech Trainers Announces John Sjovall as New Board President
4. Volcano Announces Upcoming Data Presentations from Large-Scale Studies on Physiology and Imaging Technologies at TCT 2013
5. Comprehensive Care Corporation Announces Extension of $5 Million Credit Facility
6. VirtualScopics Board of Directors Appoints Eric Converse Interim Chief Executive Officer, Announces Resignation of Jeff Markin
7. MEI Pharma Announces Pricing of Public Offering of Common Stock
8. Sorrento Therapeutics Announces Pricing of Public Offering of 4,150,000 Shares of Common Stock and Listing on NASDAQ
9. Lilly announces Tapiero retiring; Zulueta promoted to senior vice president and president of Emerging Markets
10. Webcast Alert: Heska Announces Third Quarter 2013 Earnings Conference Call Webcast
11. IRIDEX Announces Third Quarter 2013 Conference Call and Release Date
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/22/2014)... , Aug. 22, 2014  As the Medical ... sector, many leaders in this area are exploring methods ... The Medical Affairs Consortium at Best Practices, LLC ... for sharing insights about the key challenges they face. ... sharing solutions through three virtual roundtable discussions where leaders ...
(Date:8/22/2014)... DUBLIN , Aug. 22, 2014 ... "Stem Cell Research Products: Opportunities, Tools & Technologies" ... you already supply stem cell research products or you ... how essential and lucrative this market is. The authors ... to sell more effectively to scientists, to generate improved ...
(Date:8/22/2014)... Ohio , Aug. 22, 2014 MC Medical, ... Inc. (MID), a Columbus, OH medical ... distribute the FloShield laparoscopic and robotic visualization system in ... be approved for sale in Japan ... a long-time experience and an extensive product portfolio in endoscopic ...
Breaking Medicine Technology:Best Practices' Medical Affairs Consortium Survey Has Achieved Strong Participation 2Global Stem Cell Research Products: Opportunities, Tools & Technologies - 2014 Report 2Global Stem Cell Research Products: Opportunities, Tools & Technologies - 2014 Report 3MC Medical agrees to be the exclusive distributor of FloShield products in Japan 2
... WAUKESHA, Wis., April 21, 2011 ... refurbished ultrasound solutions, today announced the expansion of ... state-of-the-art ultrasound transducer repair facility in Longmont, Colo. ... not previously available in the U.S. market, offering ...
... 21, 2011 ORTHOCON, Inc., a privately-held therapeutic device company, ... HEMA SORB Absorbable Bone Hemostat Matrix for clinical use ... is a ready-to-use, biocompatible, water resistant, and absorbable putty ... cut bone. Control of bleeding from cut bone is a ...
Cached Medicine Technology:MedPro Imaging Expands Operations With Opening of Dedicated Advanced Transducer Repair Facility 2MedPro Imaging Expands Operations With Opening of Dedicated Advanced Transducer Repair Facility 3ORTHOCON® Receives CE Mark and Health Canada Medical Device License for HEMASORB® 2
(Date:8/23/2014)... Teen substance abuse ranks as one of the ... Countless adolescents throughout North Carolina struggle with a drug or ... receive professional rehab due to a lack of information available ... Troubled Teens Holly Springs is a helpline designed to make ... alcohol abusers in Wake County who are seeking to ...
(Date:8/22/2014)... Search Engine Optimization is needed ... of search engines and get more audience and ... compared many Linux hosting suppliers and announced that ... most recommended Linux hosting suppliers for webmasters from ... buy high quality Linux hosting (including VPS and ...
(Date:8/22/2014)... 2014 2014 Deep Research Report ... and in-depth research report on the Glucose Meter ... including Glucose Meter definition, classification, application, and industry ... research covers the international market analysis, including domestic ... macroeconomic environment & economic situation analysis. The report ...
(Date:8/22/2014)... Recently, Skmen.com, an experienced supplier of ... bohemian dresses in its online store. Moreover, all these ... to 28% off. All the international clients can obtain ... 2014. , The company’s professional online workers update ... worldwide customers more the latest information about its new ...
(Date:8/22/2014)... NV (PRWEB) August 22, 2014 AWeber, ... marketing services that currently helps more than 120,000 ... has caught the attention of Shane Michaels, prompting an ... a crucial element for any online marketing campaign, despite ... email in the marketing world,” reports Michaels. “AWeber is ...
Breaking Medicine News(10 mins):Health News:New Helpline Provides Teen Drug & Alcohol Recovery Information in Holly Springs, NC 2Health News:Top10BestSEOHosting.com Announces Best Cheap Hosting Suppliers Of This Summer 2Health News:Glucose Meter Industry Global (Europe, Asia, NA, ROW) Analysis Now Available at ReportsnReports.com 2Health News:Glucose Meter Industry Global (Europe, Asia, NA, ROW) Analysis Now Available at ReportsnReports.com 3Health News:Cheap Bohemian Dresses Unveiled by Experienced Supplier Skmen.com 2Health News:AWeber: Review Exposes Affordable Provider of Opt-In Email Marketing Services 2
... PITTSBURGH, Aug. 15 Researchers at the University of ... allows a common and usually harmless virus to transform ... called Merkel Cell Carcinoma (MCC). Their findings, published today ... improve diagnosis for MCC and may help in understanding ...
... NY, August 15, 2011 Regular exercise could help ... according to research published this month in Elsevier,s journal ... allows the brain to rapidly produce chemicals that prevent ... study at the National Institute of Environmental Health Sciences ...
... study conducted by Hebrew University researchers has found that ... the time of exposure and development of cancer in ... electro-magnetic fields (EMFs). Previous studies have described excess risks ... have addressed the issue of short latency periods from ...
... , NEW YORK, N.Y. (August 15, 2011) Autism Speaks, ... announcing significant findings from the largest known study of younger ... spectrum disorder (ASD). This study, based on data from the ... led by investigators from the UC Davis MIND Institute, was ...
... pandemic of ailments called the "allergic march" -- the gradual ... childhood -- has frustrated both parents and physicians. For the ... fever, and asthma have afflicted children in the United States, ... causes the march and how to derail it has remained ...
... Randy Dotinga HealthDay Reporter , FRIDAY, Aug. ... who undergo prostate removal often suffer more from incontinence ... about possible aftereffects. The findings suggest there,s a ... post-surgery and what actually happens -- and that many ...
Cached Medicine News:Health News:Pitt cancer researchers find key oncoprotein in Merkel cell carcinoma 2Health News:Exercise may help prevent brain damage caused by Alzheimer's disease 2Health News:Short latencies shown for cancer in young workers with exposures to electro-magnetic fields 2Health News:Risk of autism among younger siblings of a child with autism much greater than previously reported 2Health News:Slowing the allergic march 2Health News:Many Men Underestimate Prostate Surgery Side Effects 2Health News:Many Men Underestimate Prostate Surgery Side Effects 3
Rotary Piston Nebulizer...
... the exceptional performance you need at a price ... and durability youd expect from headlights priced much ... features our thinnest cable and adjusts from 90 ... when you reach for a headlight you can ...
... The newest STERIS lighting system ... controls, Wavelens™ technology for super-focus capability, ... shadow control and depth of field, ... backup. The system's LCD control center ...
... micro-prism refractive technology that precisely focuses ... onto the surgical site. Patented prism ... of cavity illumination, shadow control, heat ... highly maneuverable PrismAlix Series is available ...
Medicine Products: