BioSpace Collaborative

Academic/Biomedical Research
News & Jobs
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  C2C Services & Suppliers™
Europe
Asia

DIVERSITY

PROFILES
Company Profiles

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Research Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
Get Our Industry eNewsletter FREE email:    
   

Amgen (AMGN) Backs States' Efforts to Enact Biosimilar Legislation That Allows for Substitution and Supports Patient Safety


1/28/2013 9:34:32 AM

THOUSAND OAKS, Calif., Jan. 25, 2013 /PRNewswire/ -- In conjunction with our oncology biosimilars partner Actavis' announcement earlier today of our four oncology biosimilars products, Amgen (NASDAQ:AMGN) today stated that it supports state biosimilars initiatives that focus on sound science and patient safety. As a biotech company developing both innovator biologics and biosimilars, Amgen believes that patient safety does not stop at drug approval.

"Amgen endorses state policies that would put patients first and, in doing so, increase confidence in the biosimilar pathway. It is important to have consistent policies in place at the federal and state level," said Scott Foraker, vice president and general manager of biosimilars at Amgen.

States' efforts to create safe substitution rules for interchangeable biologics will help accelerate the successful implementation of the U.S. biosimilars pathway. Regulatory authorities in Europe and the U.S. have emphasized the need for long-term safety monitoring of biologics. Biologic medicines are different than traditional chemical drugs in several important ways. Biologics are so complex that they can usually only be made by a living cell. In fact, when made by different manufacturers, they differ from each other. They are also very large compared to chemical drugs and can be more sensitive to storage and handling. As a result biologic medicines have the potential to cause an unwanted immune response, which can show up months after taking the medicine. This emphasizes why Amgen believes state pharmacy acts must enhance safety monitoring of substituted biologics.

Amgen is helping educate state policymakers on these considerations to ensure that physicians, patients and pharmacists share important information about biologic substitution. To provide appropriate safeguards, patient medical records must accurately reflect the biologic medicine a patient receives, by requiring that physicians be informed within a reasonable time after an interchangeable biologic substitution has occurred. Furthermore physicians and pharmacists must work collaboratively to serve patients and protect patient safety.

Amgen believes that a notification process that does not impose an undue burden on the pharmacist is in the patient's best interest. Some proposed state legislation includes these important safeguards such as after-the-fact notification to facilitate accurate record keeping and attribution of adverse events. The company said it is critical that efficient measures close the gap in biologic traceability that could otherwise be created.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and vital medicines, visit www.amgen.com. Follow us on www.twitter.com/amgen.

CONTACT: Amgen, Thousand Oaks
Ashleigh Koss, 805-313-6151 (media)
Arvind Sood, 805-447-1060 (investors)

(Logo: http://photos.prnewswire.com/prnh/20081015/AMGENLOGO)

SOURCE Amgen


Read at BioSpace.com


Amgen
 
 

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES
 

//-->