Ustekinumab Biosimilars Update

In August 2020, we posted our findings on the various stages of prospective ustekinumab (Stelara®) biosimilar manufacturers. Since that time, some significant progress has been made by some of the players in this area. Ustekinumab may well be the first interleukin-based biosimilar product entering the market, and its main patent will expire in September 2023.

Johnson & Johnson reported third-quarter 2021 earnings in the US for Stelara at $1.57 billion, a 19% increase over those in 2020 (or approximately $6 billion annualized). This represents one of the largest immunologic category prizes after Humira® and number 8 in terms of overall global drug sales.

The Table summarizes these developments. Products by Amgen, Celltrion, and Formycon are all running neck and neck in the race for first 351(k) filing with the Food and Drug Administration. Of note, Amgen’s ABP 654 is the sole agent with public information on an active interchangeability study (planned completion in March 2023).

Celltrion and Formycon have advanced into Phase 3 trials (our original report did not report on completion of Formycon’s early-stage studies). Samsung Bioepis’ SB17 has also been added to the list (with its Phase 3 trial completion on the heels of the frontrunners). All publicly available information on clinical trials involve patients with plaque psoriasis. The reference drug, an injectable interleukin-12/23 inhibitor, is approved for the treatment of not only moderate-to-severe plaque psoriasis but also psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

ManufacturerDrugStatusPotential FDA Application
AmgenABP 654Phase 3 multiswitching study to be completed in March 2023; Phase 3 main study to be completed in June 2022Q4 2022
Formycon/BioeqFYB202Phase 3 study to be completed March 2022Q4 2022
CelltrionCT-P43Phase 3 study to be completed May 2022Q4 2022
Samsung BioepisSB17Primary completion of Phase 3 study in June 2022Q1 2023
AlvotechAVT04Phase 3 study to be completed May 2023Q4 2023
Bio-TheraBAT2206Phase 3 study to be completed May 2023Q4 2023
NeucloneNeuLaraPhase 1 study completed in 2020; Phase 3 trial not yet announcedNo earlier than Q2 2024

(This post was revised on 12/6; Thank you to Neelam Goswani for the update.)

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