Major lessons learned from Zarxio’s US launch: the start of a biosimilar revolution

Category: Review Article
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Abstract
Introduction: The first biosimilar was launched on the European market in 2006 and since then, the US market has been anticipating their arrival and the potential cost savings that biosimilars can bring to the healthcare system. Zarxio™ (filgrastim-sndz) was the first biosimilar to gain US Food and Drug Administration (FDA) approval and was launched in September 2015.
Objective: The objective of this article is to identify key biosimilar sales and marketing trends and their drivers. This will enable best practices to be outlined for biosimilar manufacturers looking to enter the US market, and reference product manufacturers who are trying to defend their market share against biosimilar entrants.
Methods: Using the first US biosimilar launch, Zarxio, as a test case, a review and analysis of US sales performance, market share, pricing trends, branding strategies and coverage detail available through public and proprietary sources was conducted. The sources included (but were not limited to) pharmaceutical and promotional audits (evaluation of the expenditures companies spend on promoting their product), Centers for Medicare and Medicaid Services (CMS) data, market intelligence databases, news media, key academic literature and company annual/quarterly reports.
Conclusion: It is likely that first-to-market biosimilar entrants will not need to employ aggressive discounting tactics (defined as 50% or higher) to gain market share, however, biosimilar manufacturers should expect more aggressive price discounts in markets with multiple biosimilar entrants for the same reference product.  As the landscape evolves, biosimilars will get favoured tier coverage and/or formulary exclusivity from payers as biosimilar manufacturers increase their rebates.  In addition, early biosimilar market entrants will also need to invest in their brand to gain buy-in from key stakeholder groups – physicians, patients, and payers through education and support via the appropriate channels.

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