Navigation Links
Amgen Backs States' Efforts To Enact Biosimilar Legislation That Allows For Substitution And Supports Patient Safety
Date:1/25/2013

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
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Amgens Full Year 2012 Revenues Increased 11 Percent To $17.3 Billion And Adjusted Earnings Per Share (EPS) Increased 22 Percent To $6.51
2. Amgen Announces 31 Percent Increase In 2013 First Quarter Dividend And Increase In Its Share Repurchase Authorization
3. Amgen to Acquire deCODE Genetics, a Global Leader in Human Genetics
4. Amarantus BioSciences Appoints Amgen Co-Founder Dr. Joseph Rubinfeld to Advisory Board
5. Amgen To Present Data From Four Phase 2 Studies At Upcoming American Heart Association Scientific Sessions 2012
6. Amgen Supports Assistance for Patients Affected by Hurricane Sandy
7. Amgen To Present At The Bank of America Merrill Lynch Global Healthcare Conference
8. Amgen To Present At The Morgan Stanley Global Healthcare Conference
9. Amgen To Present At The Baird Healthcare Conference
10. Amgen Announces Termination Of Ganitumab Phase 3 Study For Futility In Metastatic Pancreatic Cancer
11. Amgens Second Quarter 2012 Revenues Increased 13 Percent To $4.5 Billion And Adjusted Earnings Per Share (EPS) Increased 34 Percent To $1.83
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/28/2017)... Hill-Rom Holdings, Inc. (NYSE: HRC), will host its fiscal ... Friday, November 3, 2017, beginning at 7:00 a.m. (CDT) ... a.m. (CDT) / 9:30 a.m. (EDT). In ... guidance for 2018, Hill-Rom executives will also highlight the ... long-range financial outlook through 2020. ...
(Date:9/27/2017)... 27, 2017  Commended for their devotion to personalized service, ... as number one in the South Florida Business Journal,s 50 ... 5000 yearly list, the national specialty pharmacy has found its ... will soon be honored by SFBJ as the 2017 ... Set to receive his award in October, Bardisa said ...
(Date:9/25/2017)... 25, 2017   Montrium , an industry ... today—from the IQPC Trial Master Files & Inspection ... that EastHORN Clinical Services has selected eTMF ... TMF management. EastHORN, a leading European contract research ... increase transparency to enable greater collaboration with sponsors, ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... The American Board of ... its next President and Chief Executive Officer, succeeding Dr. James C. Puffer upon his ... July 1, 2018 until Dr. Puffer’s retirement at the end of 2018. Upon assuming ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Lori R. Somekh, ... member of ElderCounsel, a national organization of elder law and special needs planning attorneys. ... and rules. It also provides a forum to network with elder law attorneys nationwide,” ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network for professional women, ... towards gender equality at their inaugural Summit in New York City in June. The ... social audience of over 3 million. To watch the Mobilize Women video, click ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... Agile Software Development, has been awarded a contract by the Center for Medicare ... (BPA) aims to accelerate the enterprise use of Agile methodologies in a consistent ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... sleep apnea using cutting-edge Oventus O2Vent technology. As many as 18 ... characterized by frequent cessation in breathing. Oral appliances can offer significant relief to ...
Breaking Medicine News(10 mins):