When was Bimzelx approved?
Bimzelx (bimekizumab-bkzx) gained FDA approval on October 18, 2023, for moderate-to-severe plaque psoriasis in adults.[1] This makes it one of the newest biologics in its class, with just over a year on the U.S. market as of late 2024.
How does it compare to older IL-17 inhibitors?
Bimzelx targets both IL-17A and IL-17F, unlike older drugs like Cosentyx (secukinumab, approved 2015) or Taltz (ixekizumab, approved 2016), which block only IL-17A.[1] Developers say this dual action may clear skin faster in some patients, backed by phase 3 trials showing 85-91% achieving clear or almost clear skin at week 16.[2]
What other approvals has it received?
The European Commission approved Bimzelx in 2021 for psoriasis, followed by non-radiographic axial spondyloarthritis in 2022 and psoriatic arthritis in 2023.[3] It's also approved in several other countries, expanding its global reach before U.S. entry.
When does Bimzelx's patent protection end?
U.S. patents for bimekizumab extend into the 2030s, with key composition-of-matter patents listed until 2033 and others potentially longer via extensions.[4] No generics or biosimilars are expected soon. Check DrugPatentWatch.com for the latest expiration dates and challenges.[4]
Who makes Bimzelx and what's the pricing?
UCB Pharma, a Belgian biotech firm, developed and markets it. List price is about $8,000-$9,000 per monthly dose in the U.S., though patient assistance programs and insurance often lower out-of-pocket costs.[5]
[1]: FDA.gov - Bimzelx Approval Letter (October 18, 2023). https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761195s000lbl.pdf
[2]: New England Journal of Medicine - Bimekizumab trials (2023). https://www.nejm.org/doi/full/10.1056/NEJMoa2212061
[3]: EMA.europa.eu - Bimzelx EPAR. https://www.ema.europa.eu/en/medicines/human/EPAR/bimzelx
[4]: DrugPatentWatch.com - Bimzelx Patents. https://www.drugpatentwatch.com/p/tradename/BIMZELX
[5]: UCB Pharma - Bimzelx Pricing Info. https://www.bimzelx.com/support-and-resources/cost-and-access