US FDA issues biosimilar labeling guidance but interchangeability not addressed

31-Mar-2016 - Last updated on 01-Apr-2016 at 14:01 GMT

Biosimilar labeling will have to include a statement describing the product’s relationship to its reference drug, according to US FDA draft guidance published yesterday.

Almost eight months after Sandoz launched biosimilar Zarxio (filgastrim)in the US, the country’s Food and Drug Administration (FDA) has offered up draft guidance on biosimilar labeling and has given industry 60 days to comment.

“FDA recommends that biosimilar product labeling incorporate relevant data and information from the reference product labeling, with appropriate product-specific modifications,” the guidelines said.

But the FDA is also calling for the inclusion of a statement that the product is biosimilar to the reference product printed beneath the initial US approval date for the copycat product.

Using fictitious product names, the Agency gives the example: “NEXSYMEO (replicamab-cznm) is biosimilar to JUNEXANT (replicamab-hjxf) for the indications listed,” with a footnote explaining that a biosimilar is approved based on data demonstrating that it is highly similar to an FDA-approved biological product (reference product).

“For the Full Prescribing Information, we recommend that biosimilar product labeling incorporates relevant data and information from the FDA-approved labeling for the reference product, along with any appropriate modifications specific to the biosimilar product,” Leah Christl, associate director for therapeutic biologics at the FDA explained in a blog.

Interchangeability guidance to come

The labeling recommendations follow draft guidance set out in August last year on the non-proprietary naming of biosimilar products, and are likely to be welcomed by industry groups BIO and PhRMA which filed a citizen’s petition in December.

The petition had called on the FDA to include a statement of biosimilarity in order to “foster regulatory transparency and informed prescribing decisions.”

However, their demands that labelling should include a statement on the interchangeability of a biosimilar with its reference product were not addressed by the FDA, which said this issue will be addressed in the future.

The Agency’s long-awaited interchangeability guidance has been scheduled for release later this year.