In some cases, the only time a company reveals important developments is during their quarterly earnings calls. This past “earnings season” also yielded a few interesting tidbits.
The first notes relate to the adalimumab market, as reported by the manufacturers. First, AbbVie disclosed that third-quarter net sales of Humira in the US were down 42% to $1.76 billion (or about $7 billion on an estimated annualized basis). This equates to a 62% drop since its 2022 peak of over $18 billion, just before the launch of the first adalimumab biosimilar, Amjevita. At the same time, AbbVie’s Skyrizi sales were 48% higher, reaching $2.8 billion for the quarter, and Rinvoq increased 46%, to $1.2 billion. In other words, AbbVie is doing its best to replace lost revenue in the innovator immunology category.
Speaking of Amjevita, Amgen reported that the product racked up only $28 million in US sales for the quarter, according to Amgen. Fortunately for Amgen, other global sales have bolstered the franchise, with earnings of $138 million.
Sandoz does not report separate US sales figures for individual products. However, it noted that North American biosimilar sales (all biosimilar products) accounted for $1.7 billion for the first 9 months of 2024 and $0.6 billion for the third quarter (vs. $0.5 billion in Q3 2023). Without additional information, we can only guess that increased US Hyrimoz utilization is responsible for the revenue hike. Hyrimoz and its unbranded version comprises 14.6% of the adalimumab market share (and biosimilars overall account for 19% of adalimumab prescriptions), and has represented the bulk of adalimumab biosimilar prescribing since the beginning of the second quarter of 2024.
Despite having the only approved natalizumab (Tysabri) biosimilar, Sandoz has not been able to launch Tyruko, as the FDA has not yet given approval to the company for its John Cunningham virus (JCV) assay. Tyruko has launched in the EU, however, and Sandoz is seeing 16% market share across the pond. Currently, it is the only biosimilar approved for the treatment of multiple sclerosis. The key US patent for the market-leading multiple sclerosis biologic drug Ocrevus will expire in 2029.
As we reported earlier this week, Coherus has sold its remaining biosimilar (Udenyca) to Intas Pharmaceuticals. On its third-quarter earnings call, Coherus noted that its pegfilgrastim market share was continuing to climb, up to 28%, with net sales of $33 million. It had been hampered recently by a supply-chain problem with its contract manufacturer. Coherus sold off its adalimumab market entry and ranibizumab biosimilar within the last 18 months.
Celltrion has high hopes for Zymfentra, the US branding of its subcutaneous formulation of infliximab (Zymfentra). Sales have gotten off to a slower start, with sales for the quarter of only $4.5 million. Sold in Europe as Remsema SC, net sales were $120 million for the same quarter. Celltrion’s global sales of Yuflyma, the adalimumab biosimilar, were reported to be $65 million in the third quarter. North American net sales for its biosimilar portfolio was $163 million, down 2% from the third quarter of 2023.
Pfizer, Celltrion’s marketing partner on US sales of Inflectra, reported third-quarter revenues on this product at $65 million (up 7%) in the US. In fact, it is the only biosimilar product Pfizer reported out separately. It listed its total oncology biosimilar revenue as $176 million (down 12%) from Q3 2024. Although the company does not separate its adalimumab (Abrilada) revenue separate from its “All Other Specialty Care,” this is likely minimal.
Biocon also does not report US revenues by product. During the company’s earnings call, Biocon stated, “In the United States, we continue to deliver strong performance across our product portfolio. Our oncology franchise comprising Ogivri (trastuzumab) and Fulphila (pegfilgrastim) is witnessing robust demand that we have reported marked year-on-year market share increases, with Ogivri increasing to 18% from 11% and Fulphila rising to 21% from 15%. Our Semglee and [unbranded] insulin glargine franchise shares continue to be in the mid- to high teens, including closed-door pharmacy networks and government business.” Biocon seems to be developing a high-concentration formulation of its adalimumab biosimilar.
Alvotech announced that third-quarter revenues contributed $62 million to nine-month revenue of $128 million globally (which also included sales of ustekinumab in some EU countries and Canada). There was no reported breakout by product in the US.
