Plenty of drugmakers are working on biosimilar copies of AbbVie's ($ABBV) Humira, gunning for a piece of the med's world-leading sales. But Amgen ($AMGN) believes it's ahead of the pack in the U.S., and on Wednesday, it got one step closer to taking its shot.
The California biotech has filed its approval application with the FDA, it said--and the submission includes data to support the switching of patients from Humira to its version, dubbed ABP 501. According to Amgen, the biosimilar candidate has already shown clinical equivalence and comparable safety to AbbVie's blockbuster in late-stage clinical trials for both rheumatoid arthritis and plaque psoriasis, two of Humira's major indications.
With annual sales nearing $13 million, Humira is a popular target for knockoffs makers. In October, Baxalta ($BXLT) and partner Momenta ($MNTA) announced they were taking a copy of the therapy into Phase III trials with hopes of making their first regulatory submissions in 2017. And that team and Amgen are hardly alone. Merck ($MRK) and Samsung Bioepis are plotting global regulatory filings after posting positive Phase III results in July, and Novartis ($NVS)--the first-ever company to receive FDA approval for a biosimilar drug--is working on its own version, too.
AbbVie, though, has vehemently insisted that it'll be able to hold off biosimilar rivals until 2020 thanks to its IP protection, and some analysts agree. Over the summer, Suntrust's John Boris wrote in a note to clients that the Illinois pharma will have time to extract "maximum value" from the franchise through volume gains, pricing, label expansion and a new formulation, all "well before" Amgen and its peers roll their copies onto the U.S. market.
But Amgen is hoping ABP 501 can help plug the holes in its own top line that biosimilars are set to create. Novartis' first biosimilar is a copy of the company's Neupogen, and in October, it announced that the FDA had accepted its regulatory submission for a potential biosimilar of Amgen's Enbrel, an anti-TNF med that took fifth place last year on the list of the world's best-selling drugs with close to $9 billion in revenue.
- read the release
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