- A biosimilar candidate made by Amgen is "highly similar" to AbbVie's Humira, the world's top-selling drug, according to a report by Food and Drug Administration staff.
- The report was released ahead of an advisory panel meeting scheduled for next week to decide whether Amgen's drug, called ABP-501, should be approved as a biosimilar version of Humira.
- Humira brought in over $14 billion in revenue for AbbVie last year and faces potential competition from a number of biosimilars, most notably Amgen's copy.
Unsurprisingly given how lucrative Humira is, AbbVie has said it plans to defend Humira's patent protection vigorously. Although the patent on Humira's compound (adalimumab) expires in December of this year in the U.S., AbbVie has non-composition of matter patents covering the drug which run through 2022.
The staff report for Amgen's biosimilar copy likely sets up a favorable advisory panel review for the drug Tuesday next week. While the FDA doesn't have to follow the advice of its advisory committees, it usually does.
"The data submitted by Amgen support a demonstration that ABP 501 is highly similar to US-licensed Humira, notwithstanding minor differences in clinically inactive components, and support a demonstration that there are no clinically meaningful differences between ABP 501 and US-licensed Humira," the report said.
While an approval for ABP-501 would not clear any potential patent litigation brought by AbbVie against Amgen, it would be a clear signal of the looming patent cliff for Humira.
The U.S. Patent office also recently accepted a petition from Coherus BioSciences to review some of AbbVie's non-composition of matter patents which protect the dosing regimen of Humira in rheumatoid arthritis.