Biosimilar Labeling Stirs Concerns

by Amanda Conschafter, blog editor


Will the labels used for biosimilars help – or hinder – the adoption of these new medications? Stakeholders weighed in on the issue at a recent Alliance for Patient Access sponsored panel discussion held in conjunction with the American Academy of Dermatology’s annual meeting. And a new survey of physicians suggests that health care providers have a clear stance: patient safety demands transparent labels with biosimilar-specific data.

As with naming conventionsphysician notificationprocedures and indication extrapolation, effective standards reflect biosimilars’ unique nature. Biosimilars are not generics. Thus, applying the procedures used for generic drugs may not adequately inform physicians – or protect patients.

And the very purpose of a prescription drug label is to give health care professionals the information they need to safely prescribe drugs.

Labeling includes all printed information that accompanies a prescription medication. For biosimilar labels, physicians need basic details, such as whether the product is a biosimilar and has been FDA approved as “interchangeable.”

Labels also include data from the studies conducted by the medication’s manufacturer. And on this point, biosimilars differ from traditional generics substantially. Generic drugs rely on testing data from the referenced brand-name medication’s manufacturer. The Abbreviated New Drug Applicationprocess used to approve generic drugs does not require the generic drug companies to provide their own data.

But biosimilars are a different story. Biosimilars are approved through the 351(k) biologics license application, which does require data – a significant amount of it – from the biosimilar’s manufacturer. Given that biosimilars are not identical to the biologic they resemble, health care providers and patients need access to this data. Otherwise, physicians may hesitate to prescribe biosimilars for their patients.

But so far the FDA has not demonstrated a commitment to clear and transparent labeling. The first and recently approved biosimilar in the U.S., Zarxio™ (filgrastim-sndz), carries a label almost identical to that of the reference product. The FDA has confirmed that the Center for Drugs Evaluation and Research plans to release guidance on labeling in 2015, establishing once and for all how clear and complete physicians’ information about biosimilars will be.


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