In early May, manufacturers reported their first-quarter earnings. These earnings reports usually have some valuable information about the company and industry as a whole. BR&R listened in on a few of them to pick up some morsels that point to the important industry trends.
Coherus’ On-Body Injector
On the biosimilar side of its portfolio, Coherus Biosciences revealed that its Yusimry® adalimumab biosimilar sales barely registered, at $3.9 million in the first quarter. This was not surprising considering Coherus’ own statement that this is no longer a core business for the company.
However, we were more interested in the performance of its pegfilgrastim on-body injector (OBI) formulation. The Udenyca® OBI was launched in February 2024, so its effects on revenues and marketshare are not fully reflected in the first-quarter results. In any case, net sales of Udenyca were $42.7 million in the quarter, an 18% increase over the previous quarter and a 63% increase compared with Q1 2023. The company’s marketshare has increased to 25%, and that will likely grow as it competes directly with Neulasta® OnPro®. So far, the company’s unique autoinjector contributed 8% to the revenues, and the OBI only 2% from its late introduction. The company’s executives believe that the OBI formulation will be the primary driver of growth in 2024.
Amgen’s Biosimilar Portfolio Performance
In the US, Mvasi® is Amgen’s best-performing biosimilar, with $105 million in Q1 sales. Globally, the bevacizumab biosimilar brought in $202 million. Worldwide sales are close to last year’s figures, which should be considered a positive. As prices moderate for products that have been sold for several years, it is exceedingly difficult to avoid declining revenues.
Amjevita® continues its lackluster US performance, with only $30 million in US sales for the quarter, but worldwide, its net revenues grew by 2% to $168 million.
Other biosimilar products were not broken out in its earnings report, but the “Other product category” included the “other biosimilar” sales worldwide of $176 million in Q1 2024, compared with $121 million in 2023. This category includes Kanjinti®, Riabni®, and Avasola®.
Sandoz’s Growth
Sandoz has seen some promising signs recently. Since its April 1 implementation, its arrangement with CVS Health (and its Cordavis subsidiary) has resulted in an impressive uptake in Hyrimoz® prescriptions. In its earnings presentation, the adalimumab biosimilar stands at 13% of new prescriptions through the end of April. The CVS deal excludes Humira®, with unbranded Humira®, Hyrimoz, Cordavis-branded Hyrimoz, and Hadlima® as the options. According to Endpoints, pushback from patients or doctors wanting to stick with the reference product has been minimal, and about 93% of people taking an autoimmune medication are using a biosimilar version (although this calculation may include biosimilar infliximab as well).
Overall, Sandoz’s revenues from biosimilars worldwide grew 21% to $0.6 billion overall (counting only 1 month of Cimerli® sales and without launching Tyruko®). Their presentation does not break down sales by product in the US, but it would be interesting to note figures for Ziextenzo®, for which average sales price figures have not been released by the federal government since July 2023.
They have one near-term pending FDA decision on a biosimilar, for insulin glargine; the 351(k) application was filed in February 2023. The decision is potentially overdue (or Sandoz has not announced a negative outcome).
Celltrion’s Subcutaneous Formulation of Infliximab
Global biosimilar sales for Celltrion jumped 58% in Q1 2024, with Europe accounting for 51% of the total. Celltrion’s subcutaneous formulation of infliximab (Zymfentra®) only launched in mid-March in the US, so it is not a real contributor to net sales for the quarter. However, Celltrion signed a deal with Express Scripts as the preferred drug on the PBM’s national preferred formulary. This should help jumpstart prescriptions of this pharmacy benefit–friendly version of Inflectra®. Zymfentra is not considered a biosimilar, as Remicade®, the reference product, is not available in a subcutaneous formulation. This injectable form has seen its marketshare rise in Europe, up to 21% through the fourth quarter of 2023, and growing steadily.
AbbVie Humira® Earnings
US Humira net revenues in the first quarter of this year were $1.8 billion, 40% below that from Q1 2023. If these figures are annualized, this would be $7.08 billion, which almost certainly overstates Humira’s potential revenue. The figure does not account for previously announced biosimilar manufacturers’ deals with CVS Caremark and ESI, the former of which is already reducing Humira prescription volume. Even if $7 billion could be reached in 2024, this would represent a 42% decrease from 2023 net revenues, and an impressive 65% lower figure than in 2022, before adalimumab biosimilars were launched. Of note, Skyrizi® net revenues in the US were $1.6 billion, an increase of 43%, and may well overtake Humira as its highest revenue autoimmune medication (though it is not known whether this net figure accounts for any revenue sharing from Skyrizi with development partner Boehringer Ingelheim).
Note that some manufacturers based outside the US do not (or are not required to) provide the same earnings information as those headquartered in the US (e.g., Samsung Bioepis). In addition, companies that are partnered with others on some products (e.g., Organon, Biogen, Amneal, among others) may only list their own net revenues and not total sales of the biosimilar.
