Right now, Novartis' ($NVS) Sandoz has the only biosimilar on the U.S. market. And it's looking to make it two.
On Friday, the company announced that the FDA had accepted its regulatory submission for a potential biosimilar of Amgen's ($AMGN) Enbrel, an anti-TNF med that took fifth place last year on the list of the world's best-selling drugs with close to $9 billion in revenue.
The Swiss pharma giant is looking to nab approval in for all the indications on Enbrel's label, which include rheumatoid arthritis and psoriasis. And it thinks the "totality of evidence in its submission"--including results from a pharmacokinetic study and a safety and efficacy study--"will demonstrate that the proposed biosimilar is essentially the same as the reference product," it said in a statement.
Outside the U.S., where Pfizer ($PFE) markets the drug, Merck ($MRK) and Samsung Bioepis recently won approval for a version in South Korea, and Samsung and Biogen ($BIIB) are working to do the same in Europe, Reuters notes. But as far as Sandoz knows, its application is the first for biosimilar Enbrel that stateside regulators have accepted.
For Amgen, an Enbrel copy in the U.S. would put $4.7 billion in 2014 revenue in jeopardy, and the California biotech has been preparing for that eventuality. Last July, it announced far-reaching job cuts affecting 2,900 positions--or 15% of its workforce. Since then, Novartis has already begun threatening Enbrel's slice of the pie with next-gen psoriasis-fighter Cosentyx, which hit the market earlier this year.Novartis, on the flip side, is looking to add an Enbrel knockoff to the stable of biosimilar products it's building, where Zarxio--a copy of Amgen blockbuster Neupogen--has been holding down the fort since getting the FDA's green light in March.
Despite the regulatory go-ahead, Zarxio didn't launch until last month. Legal squabbling resulted in an injunction that held the product off through Sept. 3, when Sandoz rolled out the therapy with a 15% discount to Amgen's brand.
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