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FDA Issues Final Guidance on Biosimilar Labeling, Sticking with Generic Model

Earlier this month, FDA issued final guidance on the labeling of biosimilar products. The final guidance continues the approach adopted in FDA’s March 2016 draft guidance. That approach largely treats biosimilars like generic drugs for purposes of labeling, even though biosimilars, unlike generic drugs, are not exact copies of innovator products.

Generic drugs must adopt the same label as their reference drugs, with minor deviations permitted only in limited circumstances.  Like a generic label, the label for the first FDA approved biosimilar, Zarxio, was essentially identical to that of its reference product, Neupogen. The Zarxio label led to criticism from physicians and industry on the basis that the label did not state that Zarxio was approved as a biosimilar of Neupogen, nor did it state that Zarxio had not been determined to be interchangeable with Neupogen.

To address the first concern, the draft guidance recommended inclusion of a “biosimilarity statement” in the highlights of prescribing information.  This recommendation carries over, with slightly revised text, in the final guidance. The statement should read as follows:

[BIOSIMILAR PRODUCT’S PROPRIETARY NAME (biosimilar product’s proper name)] is biosimilar* to [REFERENCE PRODUCT’S PROPRIETARY NAME (reference product’s proper name)]. 

This statement is to be accompanied by the following footnote:

*Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of [BIOSIMILAR PRODUCT’S PROPRIETARY NAME] has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.

The second sentence of the footnote is new to the final guidance.  The draft guidance referred only to “indications listed,” rather than the broader category of “condition(s) of use.”

In addition, certain product-specific deviations from the label of the reference product are permitted.  The final guidance provides that the information provided in a biosimilar label “may differ from that of the reference product labeling when it reflects differences between the biosimilar product and the reference product that do not preclude licensure of the biosimilar product.” In addition, because a biosimilar may be licensed for fewer than all of the approved indications of a reference drug, the guidance specifies that the biosimilar label should include only the information relevant to the approved indications of the product.

However, the general rule remains that the reference product serves as the starting point for the biosimilar label.  For instance, in general, the label should include only clinical trial information from the clinical trials used to support the initial approval of the reference product, not data from the clinical trials used to establish biosimilarity. This approach ensures that differences between the labels are limited.

FDA deferred consideration of labeling for interchangeable products.

Categories: Biosimilars, BPCIA, FDA, Labeling
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