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Submitted to the Editor - New York Times

February 12, 2013

To The Editor:

The Editorial “Improper Efforts to Limit Competitive Drugs,” on Feb. 9 omits several key facts. These are: FDA can approve biosimilars now, without additional guidance and regulations; FDA can finalize guidance after approvals; currently no state law addresses automatic substitution of biologics; biosimilar development is ongoing with at least 12 products in clinical development for the U.S.

State legislation would create, not restrict, biosimilar substitution.  Payers’ ability to favor biosimilars through benefit structures would be unaffected. 

State requirements for patient consultation are not novel hurdles to blunt biosimilar competition.  These provisions are current law for pharmaceuticals in most states. Amgen supports policies that inform physicians about the product their patients received. This fosters patient safety and reflects the differences between biologics and traditional pharmaceuticals.

Amgen plans to commercialize biosimilars. We do not support legislation or measures to constrain biosimilars uptake.

Joseph Miletich, M.D., Ph.D.
Senior Vice President, Amgen Research & Development
Thousand Oaks, CA