Judge says Novartis can launch biosimilar of Amgen's Neupogen

Novartis CEO Joe Jimenez

Novartis ($NVS) CEO Joe Jimenez was a bit dismissive about the immediate impact of biosimilars when his company became the first to get one approved in the U.S. But Amgen ($AMGN) didn't see the biosimilar of its blockbuster Neupogen in quite the same light and tried to stop its release. Unfortunately for the company, a federal judge denied Amgen's request for a temporary injunction.

Neupogen fights infections in cancer patients and the FDA approved Novartis' copy earlier this month but the release was halted by Amgen's court action. Thursday's decision allowing the release of Novartis' drug Zarxio does not a put an end to the fight. Amgen said it would appeal Thursday's ruling. Novartis, the Wall Street Journal reports, had held off on the release of Zarxio until the court ruled but didn't say if it would do the same while the decision is appealed. Amgen has said that it might also take Novartis to court with its contention that Zarxio violates patents of Neupogen, a drug that raked in $1.2 billion last year.

Of course other biosimilar developers are anxiously watching to see what kinds of legal mud wrestling they might get into when their own drugs are approved. More importantly, they want the drug to get to market to see how doctors and patients respond to the copies of biologic drugs.

There have been widely varying projections of just how grand the biosimilar market will be financially. Some say only $35 billion this decade, while others forecast closer toward $200 billion. Their uptake in Europe, where they have been available for years, has been tepid. But then again, Europe's national payer market is a different animal than the U.S. where pharmacy benefit managers (PBMs) have a lot to say about which drugs are paid for under employer health plans. Troyen Brennan, chief medical officer for CVS Health ($CVS), told Reuters this month that the PBM sees biosimilars coming in at discounts of 40% to 50%, which is more aggressive than the 20% estimates that have been floating around for years.

Pfizer ($PFE) is confident enough about the market that it recently agreed to pay $15 billion for Hospira ($HSP), in part, because of its foothold in the biosimilar market. Hospira and its biosimilar partner Celltrion have a copy of Johnson & Johnson's ($JNJ) blockbuster autoimmune drug Remicade pending before the FDA but last month the agency said it was delaying a meeting that had been set for this week for consideration of their drug while the two fed the agency some more info.

It is these kinds of issues that left Novartis' Jimenez sanguine about his company being the first to file for a biosimilar application. While he expects Novartis' generic unit Sandoz to be a big player in the biosimilar business, and for the biosimilar business to be big, he said that it will take at least 5 years before the industry knows how regulators, payers, patients and healthcare providers will take to them. "By the year 2020, which is just 5 years from now, you're going to see a big impact," he said at the time.

- read The New York Times' piece
- here's the Wall Street Journal story (sub. req.)
- and more from Reuters

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