Biosimilar comparative data not needed on labels, says FDA
The FDA has recommended that data comparing biosimilars with originator molecules does not need to be incorporated on their labels.
In draft guidance published yesterday, the US drug regulator said it was taking this approach to avoid confusion or misinterpretation of the comparative data used to establish that the biosimilar is a near-copy of a biological medicine.
The FDA instead said that biosimilar labelling should include relevant data and information from the approved labelling for the reference product, along with any modifications specific to the biosimilar.
For instance, labels may vary if a biosimilar manufacturer has decided not to market the near-copy in all of the originator product’s indications, said Leah Christl, associate director for therapeutic biologics at the FDA, in a blog post.
Potential differences in clinical study parameters, may lead to confusing or even misleading information for health providers, said Christl.
Christl noted that comparative data will generally be publicly available in product reviews on the FDA’s website, should healthcare providers wish to “delve more deeply” into comparative data.
The FDA’s approach is comparable the European Medicines Agency’s guidance, which requires a biosimilar medicine to derive its summary of product characteristics from a reference product.
Christl added that the FDA is finalising rules on naming of biosimilars following a consultation on proposals to add a four-letter suffix to the their non-proprietary names.
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