Biosimilar Labeling Variation From Reference Product OK, FDA Says

A biosimilar that is not licensed for all of the indications on a reference product's label may still need to include some information about that off-label indication to ensure safe use, draft guidance says.

FDA appears open to more variation between the labels of a biosimilar product and its reference biologic than may have been evident in its first approval under the 351(k) pathway.

Although biosimilar labeling should incorporate relevant data and information from the reference product's labeling, there are situations in which the...

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