First Biosimilar Approval Lacks Needed Safety Guidelines

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March 20th, 2015

The press release below was sent out on March 6th, 2015 in response to the FDA’s approval of the first biosimilar.

Today, the FDA approved the first biosimilar to be authorized for use in the United States.  While the approval of Zarxio (a biosimilar to the reference biologic Neupogen) was no surprise (it has been approved for use for a number of years in Europe) it was very troubling considering that the FDA has not yet released guidance on critical safety measures on how a biosimilar should be named, tracked, and how the manufacturing process will be regulated, inspected and controlled.  It is the precedent that this approval sets that troubles RetireSafe.

Future biosimilars may not have the prior use information of this first biosimilar and will probably be more complicated.  It should be noted that even with the background of usage in Europe this product was still NOT approved as an interchangeable replacement (meaning it could be substituted without any notification) but as a biosimilar, meaning that the drug was only similar to the reference biologic.

In deciding on the name for this first approved biosimilar they were quick to point out that the name they assigned “should not be viewed as reflective of the agency’s decision on a comprehensive naming policy”.  That statement was necessary because they have not yet released a naming policy.  They went on to say that they would be coming out with a naming policy in the near future; they have been saying that for over two years.

The over 1,400 older Americans who took our survey concerning biosimilars overwhelmingly indicated that safety with these new medicines was paramount.  The success of these money saving biosimilars can only be achieved if there is a trust by both the patient and the healthcare provider that this medicine is safe.  Careening forward with biosimilar approvals without the input from those groups who represent the patients and the older Americans who are most likely to use this drug and without the guidance and regulations that will ensure that any adverse effects can be tracked is not a way to build this trust.