Over the past month, several developments have been noted in the adalimumab product space, and we summarize them below.
First, according to its early October press release, Pfizer planned to launch its interchangeable biosimilar Abrilada® by the end of that month. Pfizer’s switching studies were carried out using the low-concentration formulation (LCF), so it is assumed that it is interchangeable with the LCF version of Humira® only (occupying the same competitive slot as Boehringer Ingelheim’s Cyltezo®). The launch of this second interchangeable also calls into question the 180-day exclusivity period, since Cyltezo launched on July 1. Pfizer had announced that Abrilada would be available initially at a 5% discount to Humira’s wholesale acquisition cost (WAC), with its intention to introduce a lower WAC offering (of 60% below Humira’s WAC) before the end of the year. This could result in significantly less savings than some of the other biosimilar adalimumab offerings (with discounts > 80%), unless Pfizer piles on more rebates or further incentives.
In early October, Boehringer Ingelheim launched its unbranded, low-WAC version of Cyltezo, with an 81% discount to Humira’s list price. The product is an LCF version of adalimumab (like Cyltezo) that is interchangeable with the reference product.
On November 3, the FDA approved AbbVie’s application to market its long-anticipated unbranded version of Humira. AbbVie has not yet signaled its launch schedule or pricing, but it is anticipated to be marketed as a low-WAC competitor to the other biosimilar branded and unbranded products for 2024.
Here is an update of the chart we first posted after the July 1 launches.
|BIOSIMILAR WAC DISCOUNTS RELATIVE TO HUMIRA PRICES|
|Cyltezo||Boehringer Ingelheim||5%||LCF (interchangeable)|
|(Unbranded)||Boehringer Ingelheim||81%||LCF (interchangeable)|
|Hulio||Biocon Biologics/Kyowa Kirin||5%||LCF|
|(Unbranded)||Biocon Biologics/Kyowa Kirin||85%||LCF|
*Not yet launched; †Amgen’s HCF version has been approved but no public announcement has been made about branded/unbranded, pricing, or launch date. HCF = high-concentration formulation; LCF = low-concentration formulation; TBD = to be announced.
Data gathered from corporate websites, E-mail communications.
(Note: Thanks to Neelam Goswami for the heads up on AbbVie’s approval)