Novartis’s Sandoz is aiming to bring a biosimilar of Amgen anti-TNF giant, Enbrel, to market. And it just rolled out efficacy data that could help it get there.
Thursday, the generics behemoth announced that its copycat had met its primary endpoint in a psoriasis trial, posting comparable efficacy to Enbrel by hitting the equivalence mark on the Psoriasis Area and Severity Index after 12 weeks. The incidence of adverse events was comparable at that point, too, Sandoz said.
The data make up part of a package that’s already been accepted for review by the FDA and European Medicines Agency, according to the company. It’s hoping to snag a green light in all of Enbrel’s approved indications--including psoriasis and rheumatoid arthritis--to have the best shot of nabbing a piece of the $5.10 billion in U.S. sales that Enbrel raked in last year.
And the company already accomplished the feat once. Last March, the FDA approved Zarxio--a copy of Amgen’s Neupogen--to treat all of Neupogen’s indications, though the med didn’t launch until September thanks to legal tussling between the two companies.
Amgen, for its part, doesn’t want to see another of its major meds come under biosimilar attack--especially before it can launch some of its own biosimilar prospects. Partner Pfizer, which markets Enbrel overseas, has already had that misfortune: In January, European regulators approved an Enbrel knockoff from Samsung Bioepis, to be sold by Biogen and rolled out gradually across the EU countries, along with Norway, Iceland and Liechtenstein.
Of course, biosimilar launches are a newer concept in the U.S., which has so far only seen Zarxio’s. And Sandoz, for one, has already felt the effects of a slower market. While Novartis blamed broader generics-industry trends for weak Sandoz Q4 sales, Bernstein analyst Ronny Gal suggested at the time that slow biosimilar development and uptake was to blame, and that Sandoz’ biosimilar push--along with a corresponding de-emphasis on “simple generics”--had created a gap in launches.
- read Sandoz's release
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