Drugmakers had high hopes for the FDA's biosimilars labeling guidance; both reference-product drugmakers and copycats figured they might be able to use biosimilar labeling to their marketing advantage, depending on the language. But no dice, the FDA said late last week.
The agency took a stand for "generic-like" biosimilar labels, as Bernstein analyst Ronny Gal put it Friday to investors. The way regulators see it, data proving a drug's biosimilarity shouldn't make the cut; instead, labels should read like those of normal knockoffs. The FDA wants biosimilar labels to "contain the information needed by the physician to use the product--essentially the innovator's label," he wrote. And it wants no more than a "simple statement" about what biosimilarity means.
The results, if the guidance goes through? For one, reference-product makers won't be able to nitpick labeling data to argue against the adoption of biosimilars, the way AbbVie ($ABBV) envisioned when it last June released a citizen's petition supporting "a concise description of the pertinent data developed to support licensure."
On the other hand, biosimilar marketers won't be able to use their own labels to back their arguments against biosims from other developers. For "larger companies with strong marketing muscle" that "hoped to use their more robust clinical program as a commercial differentiator … this would be more challenging with this data not on the label," Gal noted.
The new guidance also weakens the "biosimilars are not generics" mantra that reference-product makers have repeated for some time now, to reassure investors that biosimilars wouldn't quickly tank their sales
But according to Gal, there are still multiple factors out there--such as interchangeability guidance, which is still yet to come--that could help biosimilars "to develop along either branded or generic lines." He thinks the "most likely trajectory" is "early development along branded lines with later transition to generic-like market structure." The content of the label is "only one, if meaningful, input into the mix."
- see the FDA's guidance (PDF)
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