Amgen stalls Apotex's Neulasta biosim launch with court victory

Apotex is working on a biosimilar of Amgen's ($AMGN) Neulasta, but if and when it wins FDA approval, it'll have to wait awhile before launching, a court ruled on Wednesday.

A Florida District Court has granted the California biotech a preliminary injunction against Apotex based on its interpretation of the Biologics Price Competition and Innovation Act, ruling that the act requires copycats to give makers of their reference products 180 days of notice before they bring a knockoff to market.

Quoting the decision of the court that delayed Novartis' ($NVS) Sandoz in launching Zarxio, its biosimilar of Amgen's Neupogen, District Judge James Cohn wrote that giving reference product makers that 180-day notice--after a biosimilar has won FDA approval and "the scope of the approved license is known"--gives them the opportunity to figure out whether they can try for an injunction on patent infringement grounds.

And that's just what Cohn expects to happen with Amgen and Apotex. "The 180 days afforded to Amgen by the injunction it seeks will Iikely result in a more crystallized patent Iitigation before this court," he wrote in the decision.

Amgen is working to do as much as it can to stave off biosimilar competition to its older best-sellers, and it had some success delaying Zarxio. After winning approval in March of this year, the med couldn't launch until September thanks to an injunction.

But with one biosimilar now in the bag, Sandoz is trying to bring its second Amgen knockoff to market. 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.

Meanwhile, though, Amgen is looking to make up for biosimilars-induced revenue holes with some copycat drugs of its own. Earlier this month, the company filed an approval application with the FDA for its version of AbbVie best-seller Humira; according to Amgen, its candidate has already shown clinical equivalence and comparable safety to the Illinois company's blockbuster in late-stage clinical trials for both rheumatoid arthritis and plaque psoriasis, two of Humira's major indications.

- read the decision (PDF)

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