Sandoz head: Enbrel biosimilar Erelzi won't launch before 2018, delayed by legal battle

Syringe
Novartis a legal fight with Amgen over its biosimilar of Enbrel will not be resolved before next year.

Novartis CEO Joe Jimenez today pointed to the company’s biosimilars program as being one buffer if President Trump’s threat to cut drug prices should materialize into some action. The drugmaker has two approved biosimilars that it can offer caregivers to save money. But the problem is, given the legal fight it is in with Amgen, it will be next year, or beyond, before it will be able to tap any of the $5 billion in U.S. sales enjoyed by Amgen’s Enbrel.

Richard Francis, head of Novartis's Sandoz generics business, told Reuters today that approval or not, it takes a long time to fight these battles.

“That won't really reach a conclusion until 2018," Francis said. "That's the frustration sometimes of the legal situation, but the way I look at that, we're carving the landscape out as we go."

It has been nearly 5 months since Novartis won FDA approval for Erelzi as a replacement for Enbrel. Once on the market, doctors can prescribe it in place of Amgen’s drug for any of its indications—including rheumatoid arthritis, plaque psoriasis and psoriatic arthritis.

But even before its approval, Amgen sued the Swiss drugmaker over patent issues, saying Novartis was “piggybacking on the fruits” of its Amgen’s trailblazing efforts.”

In addition to the patent fight, another legal battle between the two companies is now before the U.S. Supreme Court that will affect how quickly biosimilars get to market. The Supreme Court this month agreed to consider arguments over when a required six-month waiting period begins to run after a biosim company notifies the original developer about its would-be rival drug.

A federal appeals court had ruled that companies must have an FDA approval in hand before they can officially notify a launch. Sandoz argued that the court's interpretation created an “exclusivity windfall” for the originator company not envisioned by Congress when it wrote the Biologics Price Competition and Innovation Act. The Novartis unit has made the case that biosim makers should be able to provide that notice earlier in the development process so drugs can launch shortly after their approval.

Still, Jimenez is confident that Novartis' biosimilars business will help it through a tough period, he said when announcing weak Q4 earnings today.

“What better position to be in than with a $10 billion generics business, which can help healthcare systems to lower the cost of care with these biosimilars,” he said, according to Pharmaphorum.