The age of biosimilars in the U.S. has finally dawned with the launch of Novartis' Zarxio, a copy of Amgen's Neupogen (filgrastim). And it's arriving with a 15% discount to win scripts over from the brand.
Thursday, the Swiss pharma giant announced its Sandoz generics unit had begun rolling out the med in the U.S., which the FDA green-lighted back in March after years of drawing up a biosimilars regulatory approval pathway.
Legal squabbling between Novartis ($NVS) and Amgen ($AMGN) over patent infringement has kept the drug from hitting the market sooner, though. The U.S. Court of Appeals for the Federal Circuit--which initially blocked Zarxio's launch in May--eventually decided to keep an injunction on the drug in place until this week.
Now, though, the U.S. is catching up with Europe, Australia and India, to name a few markets where biosimilars are already making their mark. How much of a mark Zarxio can make, though--and how quickly--still remains to be seen.
|Novartis CEO Joe Jimenez|
Novartis CEO Joe Jimenez, for one, has said he's not expecting too much of a splash before 2020, and a recent doctor community survey from QuantiaMD suggests he may be right. Only 17% of the participating physicians Quantia deemed most likely to prescribe biologics--and, thus, the most likely to prescribe biosimilars in the future--said they were "very likely" to do so. Seventy percent said they either weren't sure or were "somewhat likely" to write a biosimilar script.
The way Jimenez sees it, it'll take a while for the industry to figure out how doctors--as well as patients and payers--feel about the newcomer drugs, and in the case of Zarxio, that would be just fine by Amgen. Neupogen hauled in $839 million in the U.S. last year, and second-best-seller Enbrel is also facing new competition from next-gen psoriasis fighters.
The California company does have a new approval in hand, though, that'll help soften the blow. Late last week, the FDA gave PCSK9 contender Repatha the go-ahead, setting up a mammoth contest between the med and Sanofi's ($SNY) Praluent.
- read the release
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