The Biosimilars Trend Report published in 2020 describes the landscape for biosimilars in the US. The current biosimilars available for oncology therapeutics are trastuzumab, bevacizumab and rituximab. Overall, biologicals make up approximately half of all oncology products and they are expensive due to higher development and production costs. Biosimilars offer an opportunity to reduce the cost of oncology treatments. As of July 2020, 12 oncology biosimilars were available in the US.
Oncology therapeutics
In the US, oncology biosimilars have had strong growth, with trastuzumab and bevacizumab accounting for at least 40% of sales by volume.
Trastuzumab
Trastuzumab’s originator is Herceptin. This now has five competitors that were all launched at lower wholesale acquisition cost (WAC) and average sales price (ASP) than Herceptin. All trastuzumab biosimilars launched at prices of 7%‒20% less than the ASP of Herceptin. With successive launches, some launched at greater discounts than their predecessors offered but were not always launched as the cheapest trastuzumab product available, see Figure 1.
Figure 1: ASP of trastuzumab products at biosimilars launches
*Q2’20 sales data through 3 July 2020; monthly rollup based on 4-4-5 calendar.
Biosimilar WAC price used for comparing against reference product ASP until biosimilar ASP is available.
ASP: average sales price; WAC: wholesale acquisition cost.
Source: Analysource.
Trastuzumab biosimilars have had high uptake and at the time the report was published, Kanjinti approved in the US in June 2019 [1] had captured a 33% market share. The other biosimilars had not been on the market for long, so their share was much smaller.
Other trastuzumab biosimilars: Herzuma (trastuzumab-pkrb), Ogivri (trastuzumab-dkst), Ontruzant (trastuzumab-dttb), Trazimera (trastuzumab-qyyp) have also been approved in the US [2].
Bevacizumab
Bevacizumab’s originator is Avastin. This now has two competitors that were launched at lower WAC and ASP than Avastin. The second biosimilar to launch, Zirabev, had a lower ASP than the first, Mvasi. However now, the ASP of Mvasi is lower than that of Zirabev, and both remain lower than the ASP of Avastin, although that has decreased by 2% since biosimilar market entry, see Figure 2.
Figure 2: Biosimilar uptake curve for trastuzumab products
*Q2’20 sales data through 3 July 2020; monthly rollup based on 4-4-5 calendar.
Source: OBU Customer Data Pack Weekly (IQVIA DDD + Chargeback).
Mvasi and Zirabev were approved in the US in September 2017 [3] and June 2019 [4], respectively.
There has been a strong adoption of bevacizumab biosimilars with Mvasi capturing 38% of the market in nine months.
Rituximab
Rituximab’s originator is Rituxan. This now has two competitors that were launched at lower WAC and ASP than Rituxan. The second biosimilar to launch, Ruxience, had a lower ASP than the first, Truxima. Both biosimilars were relatively new to the market and no price concessions were yet observed for them, although Rituxan’s ASP had reduced by 1%, see Figure 3. Their future uptake levels are yet to be discovered.
Figure 3: ASP of rituximab products at biosimilars’ launches
*Q2’20 sales data through 3 July 2020; monthly rollup based on 4-4-5 calendar.
Biosimilar WAC price used for comparing against reference product ASP until biosimilar ASP is available.
ASP: average sales price; WAC: wholesale acquisition cost.
Source: Analysource.
Ruxience and Truxima were approved in the US in July 2019 [5] and November 2018 [6], respectively.
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves trastuzumab biosimilar Kanjinti [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-trastuzumab-biosimilar-Kanjinti
2. GaBI Online - Generics and Biosimilars Initiative. Top developments in biosimilars during 2019 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from: www.gabi-journal.net/top-developments-in-biosimilars-during-2019.html
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves bevacizumab biosimilar Mvasi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-bevacizumab-biosimilar-Mvasi
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves bevacizumab biosimilar Zirabev [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-bevacizumab-biosimilar-Zirabev
5. GaBI Online - Generics and Biosimilars Initiative. FDA approves rituximab biosimilar Ruxience [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-rituximab-biosimilar-Ruxience
6. GaBI Online - Generics and Biosimilars Initiative. FDA approves first rituximab biosimilar Truxima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-first-rituximab-biosimilar-Truxima
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Source: Amgen Biosimilars
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