Tony Hagen is senior managing editor for The Center for Biosimilars®.
Amgen's 2020 biosimilar report goes into detail on market share and costs for biosimilars across the therapeutic spectrum in the United States.
Biosimilars are gaining traction at a rapid rate in the United States—they have become more numerous in their first 5 years on the US market than biosimilars were in Europe in their first half decade, according to the 2020 Biosimilar Trends Report from Amgen. The report provides a detailed breakdown of biosimilar costs versus reference product costs across drug categories.
The report counts 28 biosimilars approved and 18 biosimilars launched so far in the United States. The latter figure includes Avsola, an Amgen biosimilar for infliximab, which gained approval from the FDA in December 2019 and, according to the report, was launched in July 2020.
Upbeat on Competitive Framework
The report is upbeat in its assessment of the supportive structure for the US biosimilar market, noting “many competitive mechanisms are in place to support biosimilar uptake,” among them CMS’ move to establish separate codes and payment rates for biosimilars, which the report states can lead to “meaningful cost savings and a sustainable marketplace.”
The report also praises current US regulatory standards for development and approval of biosimilars “as well as for establishing interchangeability,” stating that these are “scientifically appropriate to protect patient safety and support provider and payer confidence.”
The requirement for interchangeability, an FDA determination that would allow pharmacists to substitute biosimilars without physician consent, has at times been questioned, as have the requirements for clinical efficacy testing, which has been criticized as redundant.
“The US marketplace for biosimilars is now well established and accelerating across multiple therapeutic areas,” the report says.
Stable of Reference and Biosimilar Products
Amgen produces numerous biosimilars and reference products. On the innovative side, the company owns the pegfilgrastim brand Neulasta and also reference filgrastim (Neupogen), etanercept (Enbrel), and epoetin alpha (Epogen). In the United States, biosimilar competition exists for each of these drugs except etanercept, which is protected by exclusivity status.
On the biosimilar side, Amgen recently launched an infliximab (Avsola) and markets a trastuzumab (Kanjinti) and a bevacizumab (Mvasi). It has an approved adalimumab biosimilar (Amjevita), which has yet to launch, and it is developing additional biosimilars, including a rituximab (ABP-798).
In the United States, just 2 biosimilars have been approved so far in 2020, but 6 biosimilars have launched; and over the first 5 years of biosimilar availability in the United States, 26 biosimilars were approved compared with just 11 in the European Union, which supports the idea that, although well behind Europe in terms of biosimilar uptake, the United States is making rapid progress. The report states that, despite the scarcity of approvals so far in 2020, the number of approved biosimilars over the past 12 months is up 65% and launches are up 157%.
Still in the wings and awaiting launch are FDA-approved biosimilars for pegfilgrastim (Nyvepria), infliximab (Ixifi), etanercept (Erelzi, Eticovo), and adalimumab (Amjevita, Cyltezo, Hyrimoz, Hadlima, Abrilada, Hulio).
Pricing Differences by WAC and ASP
Of the biosimilar products that have launched, wholesale acquisition costs (WAC, manufacturer’s list price) for biosimilars have averaged 15% to 37% lower at launch than reference products’ WACs, according to the report. In addition, biosimilars’ average sales price (ASP) at launch is typically 3% to 24% below the reference products’ ASP, Amgen said.
Filgrastim biosimilars have been on the market the longest time—5 years—and have achieved a 72% share of the market, Amgen said. Bevacizumab products now have 40% of the market; trastuzumab biosimilars, 39%; pegfilgrastim, 27%; rituximab and infliximab, 20%.
The trastuzumab biosimilar Kanjinti currently has an ASP 25% below reference Herceptin’s ASP prior to the appearance of biosimilar competition in the third quarter of 2019; Herceptin is just 3% lower by ASP, according to the report.
Bevacizumab biosimilar Mvasi is 24% lower by ASP than the reference product Avastin’s ASP prior to biosimilar competion; Avastin’s ASP has dropped just 2% since the third quarter of 2019, when bevacizumab biosimilars appeared.
Rituximab biosimilars have managed to pull down the ASP of reference Rituxan by just 1% since the late 2019 launch of the first rituximab biosimilar, Truxima. Currently, Truxima’s ASP is 5% lower than the reference product’s ASP was at Truxima’s launch. However, Ruxience was launched at an ASP 20% below the reference product’s ASP and remains at that lower level, according to the report
In the category of nephrology/oncology supportive care, the epoetin alfa biosimilar Retacrit was launched at 33% below Epogen’s WAC and 5% below Epogen’s ASP. Retacrit was launched 57% below Procrit’s WAC and 5% below its ASP. Epogen and Procrit are identical drugs but are marketed by separate companies in different therapeutic areas. Retacrit now has a 25% share of the market for epoetin alpha vs 18% for Procrit and 57% for Epogen.
In the US infliximab market, 3 biosimilars have been marketed, including Avsola (July 2020). The ASP for reference Remicade has dropped to 33% below its pre-biosimilar cost, and the ASPs for Renflexis and Inflectra currently stand at 40% and 43%, respectively, below the reference product’s ASP cost before biosimilar competition, according to the report.