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Amgen Backs States' Efforts To Enact Biosimilar Legislation That Allows For Substitution And Supports Patient Safety

 Amgen Backs States' Efforts To Enact Biosimilar Legislation That Allows For
                   Substitution And Supports Patient Safety

Biologics and Biosimilars are Complex Drugs, and Their Presence in the
Marketplace Requires Appropriate Public Policy at the Federal and State Levels

PR Newswire

THOUSAND OAKS, Calif., Jan. 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

Website: http://www.amgen.com
 
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