Amgen ($AMGN) wants to do everything that it can to protect its best-selling RA drug Enbrel from potential biosimilar competition, and now, the company is shoring up its defenses by suing Novartis' ($NVS) Sandoz unit in federal court.
Thousand Oaks, CA-based Amgen in the U.S. District Court for the District of New Jersey filed a suit claiming that Sandoz infringed some of its patents for Enbrel by seeking FDA approval for its biosimilar of the med. Amgen also wants the court to grant an injunction that would prevent Sandoz from selling its biosimilar, if and when it is approved. In October, the FDA accepted Sandoz's application for its Enbrel biosimilar, moving the company one step closer to gaining full approval for the med.
The way Amgen sees it, Sandoz is "piggybacking on the fruits" of its "trailblazing efforts" in developing Enbrel, the company said in the suit. Amgen for two decades has been working on the drug, which treats a range of autoimmune diseases including psoriasis and ankylosing spondylitis. But Sandoz has only conducted clinical trials of its biosimilar for psoriasis patients, despite the fact that it wants it approved for a host of indications, Amgen alleged in its suit.
Amgen has a lot on the line with its drug. The company brought in more than $5 billion in Enbrel sales last year in the U.S. Amgen is counting on new patents won in 2011 to ward off competition to the drug through 2029.
In the meantime, the company is making headway with its own biosimilar of another competitor's top seller. Amgen recently moved closer to winning FDA approval for its biosimilar of AbbVie's ($ABBV) Humira after the agency accepted its application for ABP 501. But the company stumbled a bit after the U.S. Patent and Trademark Office rejected its attempt to challenge Humira's patents.
The latest suit is a thorn in Sandoz's side as it attempts to gain speed with its Enbrel biosimilar. Even though Sandoz leads the pack when it comes to biosimilar development, biosimilars are "coming in a bit slow overall," Bernstein analyst Ronny Gal said last month. Sandoz hopes to pick up that pace as it forges ahead with its portfolio, which includes already-launched Zarxio, a biosimilar of Amgen's Neupogen.
- read the suit (PDF)
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