FDA Panel Unanimously Backs Amgen’s Humira Biosimilar

Regulatory NewsRegulatory News | 12 July 2016 |  By 

The US Food and Drug Administration’s (FDA) Arthritis Advisory Committee on Tuesday voted unanimously to support Amgen’s biosimilar for AbbVie’s blockbuster biologic Humira (adalimumab).

The vote – 26-0, with no abstentions – followed the release of a positive review from FDA staff, and came after a lot of discussion on whether the data presented by Amgen could be extrapolated to all of the indications that Humira is approved for, as well as questions on analytical characterization and similarity.

Despite the unanimously positive vote, a number of questions were also raised about how adverse events would be tracked following the biosimilar’s approval. 

“I find it shocking that we’re still relying on passive systems to track adverse events,” David Margolis, professor at the University of Pennsylvania School of Medicine, said while explaining his “Yes” vote.

A number of the panelists also highlighted the importance of further educating the public and more physicians about how biosimilars and the approval pathway work, particularly as a number of these outside experts requested repeated explanations on the law surrounding the approval of biosimilars.

That focus on education also seems necessary given that a number of the speakers during the public portion of the meeting raised questions about the “non-medical switching” decisions that could be made by insurers and pharmacy benefit managers in switching patients from a reference product to a biosimilar that’s new to the market (because it’s less expensive than the reference product).

However, as a number of biosimilar experts have noted previously, countries outside the US (ie. Norway) have seen significant numbers of patients switch to biosimilar versions of biologics they were using previously with no signals of increased rates of adverse events or the need to switch back to the original biologic.

And although Amgen will be encouraged by the vote, the company will have to tune into another meeting on Wednesday, with many of the same panelists from Tuesday, as they discuss Sandoz's biosimilar for Amgen's Enbrel.

FDA is not required to follow any of the votes from its panels of outside experts, though it does in most instances.


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