First-Quarter Sales of Adalimumab Reveal Plenty of Savings, but Little Early Revenue for Amgen

Yesterday marked two important earnings calls for the adalimumab market, and the results were mixed at best for both manufacturers involved.

As everyone is well aware, 2023 is the year of adalimumab launches, and Amgen’s Amjevita® was the first to compete with AbbVie’s originator biologic Humira®. Launched on January 31, the question of how many Amjevita sales have been registered is on the minds of many. The first-quarter earnings presentation was the initial opportunity to understand how well the launch is proceeding and perhaps offer a window into the trend for Amjevita in the second quarter, before the mass launch of competitive products.

As reported by Murdo Gordon, Amgen’s Executive Vice President, Global Commercial Operations, Amjevita sales totaled $51 million from January 31 to March 31. This figure is unimpressive, based on AbbVie’s 2022 Humira revenue of greater than $20 billion, However, the company expects even “lower Q2 sales, as most of the Q1 sales were associated with inventory build.” Amgen indicated that most existing Amjevita sales were associated with integrated delivery networks, not the pharmacy benefit managers. The company is focused on “building demand, patient by patient, IDN by IDN.”

This implies that Amgen will not benefit greatly from its first-entry advantage. The major PBMs’ policy of covering Humira and two or three biosimilars at parity will not be a great motivator for converting share in 2023. With AbbVie’s net price closely mirroring that of Amgen (through either its high WAC or low WAC options), it would seem that lower prices will be needed to move the needle on biosimilar uptake in the short term. If both are covered at parity, providers may not perceive any need to switch from the originator at this time.

The other limiting factor for Amgen is that it does not yet have approval on its high-concentration formulation (which is the formulation utilized by 85% of patients taking Humira). The first biosimilar with a high-concentration formula to launch will be Hadlima® (Samsung Bioepis/Organon) and Hyrimoz® (Sandoz). The first interchangeable biosimilar will be Cyltezo® (Boehringer Ingelheim, but as a low-concentration formulation), and possibly AVT02 (Alvotech/Teva). These biosimilars may launch in early summer.

The adalimumab biosimilar competition has resulted in considerable savings for payers. AbbVie also reported its first-quarter earnings yesterday, disclosing that US Humira sales produced a 26% drop in net revenue compared with the same quarter in 2022 ($2.95 billion in Q1 2023). The savings is due to the competitive need to drop its net price. AbbVie expects continued Humira sales erosion as competition heats up.

In Other Biosimilar News

During its earnings call, Amgen disclosed that it filed its 351(k) biosimilar licensing application (BLA) in February for its biosimilar to eculizumab (reference product, Soliris®). Soliris is approved for the treatment of adults and children with paroxysmal nocturnal hemoglobinuria, a rare, life-threatening bone marrow disorder. An FDA decision on its product, ABP 959, would be possible in Q4 of this year or Q1 of 2024. This product was approved by the European Medicines Agency earlier this month.

Formycon announced that it had successfully completed its phase 1 and 3 clinical trial program for FYB202, a biosimilar to ustekinumab (Stelara®), and that it plans to submit its BLA in the third quarter of 2023.

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