US FDA issues biosimilar labeling guidance but interchangeability not addressed

By Dan Stanton contact

- Last updated on GMT

Related tags: Reference product, Food and drug administration

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will have to include a statement describing the product’s relationship to its reference drug, according to US FDA draft guidance published yesterday.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launched biosimilar Zarxio (filgastrim)in the US​, the country’s Food and Drug Administration (FDA) has offered up draft guidance​ on biosimilar labeling and has given industry 60 days to comment.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The labeling recommendations follow draft guidance set out in August last year​ on the non-proprietary naming of biosimilar products, and are likely to be welcomed by industry groups BIO and PhRMA which filed a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.

Related topics: Markets & Regulations, Biosimilars

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