ViewPoints: Approval of the first US biosimilar – the key questions

When will Novartis launch Zarxio? – its biosimilar version of Amgen's Neupogen; how much will it cost?; how will payers react to the first US biosimilar approval?; and will oncologists use it?

When will Novartis launch Zarxio?

FDA approval occurs independent of ongoing patent litigation between Novartis and Amgen, which will go some way to determine when Zarxio is launched in the US market. Litigation is focused on Sandoz's alleged failure to follow the patent provisions laid down in the 351(k) pathway.

After Sandoz's 351(k) application for biosimilar filgrastim was accepted by the FDA in July 2014, Sandoz had 20 days to provide Amgen with an un-redacted copy of the application and a description of the processes used to manufacture the biosimilar. In October 2014, Amgen filed a suit in the US District Court for the Northern District of California alleging that Sandoz's refusal to "dance" pursuant to the Biologics Price Competition and Innovation Act (BPCIA) constitutes unlawful acts in violation of 42 U.S.C. Sections 262(1)(2)(A) and 262(l)(8)(A) that deprive Amgen of the benefits afforded under the statute provided by Congress for brand holders, including the ability to seek a preliminary injunction against Sandoz and court intervention to prevent Amgen from suffering irreparable harm.

In response, Amgen sued Sandoz seeking an injunction against the potential launch of biosimilar filgrastim in the US in March 2015. Sandoz has counter-sued, and agreed that it will not launch its biosimilar filgrastim product in the US until the earlier of 10 April 2015, or a ruling in Sandoz's favour on Amgen's motion.

For further analysis listen to FirstWord's free Biosimilar Index Podcast – an interview with IP and legal expert Paul Calvo.

How much will it cost?

Novartis has yet to provide details on how Zarxio will be priced, but the FDA advisory committee meeting held in January to assess the product (where approval was unanimously recommended) was notable for its discussion of pricing and cost.

Responding to questioning about the price of Zarxio during the AdCom meeting, Mark McCamish said "we can't say that the price will be less because in some situations, the price will be at parity because of other relative terms that will come into existence that's there. The cost will be less to the consumer, to the payer, to the healthcare economy. It has to be. Otherwise, it doesn't make sense."

Referencing the US launch of Omnitrope, Novartis' protein growth hormone, which was approved in the EU as a biosimilar, but not in the US (where it was approved through the 505(b)(2) pathway), McCamish noted that launching with a near 50 percent price discount resulted in poor sales through specialty pharmacies, who had little incentive to prescribe the product as they receive a percentage of the price. In contrast, penetration among managed care organisations was much higher, as they evaluate the overall price.

Finding a balance will be critical in biosimilar pricing, suggested McCamish with Omnitrope's ability to compete for second/third place in terms of market share, despite being the seventh growth hormone to market, evidence of Novartis' experience in such matters.

What do payers think?

Biosimilars appear poised to debut in the US market at a time when payers – pharmaceutical benefit managers (PBMs) in particular – have become emboldened by successful strategies designed to extract greater discounts from the pharmaceutical industry.

One of the most aggressive PMBs, Express Scripts, has suggested that Zarxio could save the US healthcare system $5.7 billion over the next decade, assuming a 30 percent discount versus the current list price for Neupogen.

Will oncologists use it?

A multitude of factors will dictate the rate of adoption for Zarxio, although analysts at Bernstein were quick to note that almost identical labelling to Neupogen is a positive development for Novartis. Bernstein analyst Geoffrey Porges wrote "an uncertainty had been whether the biosimilar label would emphasize innovator data or focus on the data supporting biosimilarity. Ultimately, the FDA chose to opt for the former."

When FirstWord polled US-based oncologists in mid-January, feedback towards Zarxio appeared very positive. Thirty-six percent of respondents said they would be 'extremely' comfortable prescribing the product, with a further 36 percent describing themselves as being 'very' comfortable. Two-thirds of oncologists said the unanimous AdCom recommendation for Zarxio had had an 'extremely' or 'very' influential impact on their sentiment towards the biosimilar – see Physician Views Poll Results: Positive FDA sentiment for biosimilar Neupogen shared by oncologists.

What other factors to consider

Zarxio has been approved as a biosimilar, but not an interchangeable product. The FDA has confirmed that to support interchangeability status, Novartis would need to demonstrate proof that repeated dosing and switching with the biologic originator would not affect immunogenicity.

Approval of Zarxio has also hinted at the direction the FDA will take with regard to international non-proprietary name (INN) convention, a topic of debate between biosimilar and branded manufacturers. Zarxio has been approved with the INN filgrastim-sndz (Spotlight On: What's in a name? – FDA makes historic biosimilar approval, but is yet to decide on INN convention).

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