Submitted to the Editor - Los Angeles Times
March 18, 2013
To the Editor:
The editorial Battle over ‘biosimilars’ published on March 17 omits key facts regarding biosimilar legislation. The FDA can approve biosimilars now, without finalized guidance, and currently no state law addresses automatic substitution of biologics deemed interchangeable by FDA.
Amgen plans to commercialize biosimilars. We do not support legislation or measures to constrain biosimilars uptake. Provisions to inform patients or seek their consent are current law for pharmaceutical substitutions in most states.
Notification to a physician after substitution is not a form of consultation or consent. Physicians should know which biologic medicine their patients have taken. Fostering accurate medical records is consistent with FDA policies for these complex medicines and will promote patient safety.
We believe FDA-approved biosimilars will be safe. We also think that all responsible manufacturers should want tracking for biosimilars deemed interchangeable by FDA.
Joseph Miletich, M.D., Ph.D.
Senior Vice President, Amgen Research & Development
Thousand Oaks, CA