Launched in 2015, Zarxio (filgrastim-sndz) was the first biosimilar to gain US Food and Drug Administration (FDA) approval [1]. It competes with Neupogen (its reference product), Granix and Neulasta, for a share of the neutropenia market. This approval came almost a decade after the 2006 launch of the first biosimilar in Europe. Following this, a new study has examined Zarxio’s first years’ performance in the US short-acting (SA) filgrastim market to identify key sales and marketing trends and their drivers [2].
Zarxio’s manufacturer, Sandoz, refined its US commercialization approach from that adopted in its EU launch. The company’s primary strategies were to launch the product with modest discounting relative to the reference product, target physicians to increase awareness, and to focus on improving insurance coverage to gain US market share.
The analysis of Zarxio’s sales performance, market share, pricing trends, branding strategies and coverage has yielded several key insights into the US biosimilars market:
- In the near term, biosimilar manufacturers will see limited initial acceptance and uptake of products.
- It is anticipated that there will be modest discounts on biosimilar products (20−30%) versus reference products until there are multiple biosimilar competitors on the market.
- The US biosimilar market is evolving to resemble more a ‘branded’ market, requiring product promotion and advertisement to obtain buy-in from key stakeholders. This is in contrast to a ‘generics’ market, which typically requires little to no promotional activity.
- As biosimilars increase their rebates (greater than a 20% price differential versus the reference product) they will secure favoured tier coverage and/or formulary exclusivity from payers.
These insights can be used to guide biosimilar manufacturers that want to enter the US market. They can also help reference product manufacturers defend market share against biosimilar entrants.
Zarxio is a pioneer product in the US and its market entry has revealed useful information on the US biosimilars market. This will be particularly useful for the manufacturers of biosimilars in the recently updated ‘Purple Book,’ a list of licensed biological products and biosimilars that are biological equivalents of the ‘Orange Book’, which lists pharmaceuticals and their generic drug equivalents [3]. When it comes to market entry and uptake, it would not be necessary for first-to-market biosimilar entrants to employ aggressive discounting tactics to gain market share. However, manufacturers can anticipate aggressive price discounts to play a role in markets with multiple biosimilar entrants. As the landscape evolves and manufacturers increase rebates, it is expected that biosimilars will get favoured tier coverage and/or formulary exclusivity from payers. In addition, to gain buy-in from patients, physicians and payers, early biosimilar market entrants need to develop and invest in their brand.
Editor’s comment
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What pricing and reimbursement policies to use for off-patent biologicals in Europe? – results from the second EBE biological medicines policy survey
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves its first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 9]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-its-first-biosimilar
2. Sarshad M. Major lessons learned from Zarxios US launch: the start of a biosimilar revolution. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(4):165-73. doi:10.5639/gabij.2017.0604.035
3. GaBI Online - Generics and Biosimilars Initiative. FDA updates Purple Book for biologicals and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 9]. Available from: www.gabionline.net/Biosimilars/General/FDA-updates-Purple-Book-for-biologicals-and-biosimilars
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