Novartis' Sandoz aims for 5 biosim launches by 2020

By Carly Helfand Jun 20, 2016 9:42am

Novartis’ Sandoz may only have one biosimilar on the U.S. market right now. But come 2020, that number will be up to 5 between the U.S. and other "key geographies," it says.

The generics giant ($NVS) is aiming to have 11 biosimilar regulatory filings in the can by the end of next year--and it expects those to result in thumbs ups for copies of megablockbusters Enbrel from Amgen and Pfizer, Humira from AbbVie, Neulasta from Amgen ($AMGN), Remicade from Johnson & Johnson ($JNJ) and Merck ($MRK), and Rituxan from Roche ($RHHBY), it said in a Monday statement.

While it’s an ambitious goal--especially considering the U.S. market currently boasts just one biosimilar med--6 of those 11 filings are already on the books, Sandoz said. Most recently, European regulators accepted an application for a copy of cancer star Rituxan.

And the way the company sees it, if anyone can pull it off, Novartis is the one. It launched the world’s first biosimilar back in 2006--Omnitrope, a recombinant human growth hormone preparation--and last year it rolled out Zarxio, the first to hit the scene in the U.S.

Sandoz isn’t going to get there without some increased spending, though, and plans for that are in the works as well. It intends to sock a combined $1 billion this decade into expanding its manufacturing facilities in Austria, it said.

If Sandoz can get there, the payoff should be hefty. The reference products for the 5 approved biosimilars it sees in its 2020 portfolio generated nearly $44 billion in 2015 global sales.

But it’s not going to happen without some serious IP squabbling. AbbVie, for one, has told its investors multiple times that it has a “robust” patent defense system in place on Humira, the world’s best-selling med.

- read Sandoz' release

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