When Did Bimzelx Get Approved for Psoriasis?
Bimzelx (bimekizumab-bkzx) gained FDA approval for moderate to severe plaque psoriasis in October 2023.[1] This made it a relatively new biologic option, arriving about seven years after interleukin-23 inhibitors like guselkumab (Tremfya) in 2017.
How Does Bimzelx Work Differently?
It targets both IL-17A and IL-17F cytokines, unlike older IL-17A-only drugs such as ixekizumab (Taltz) or secukinumab (Cosentyx).[1] Phase 3 trials (BE VIVID, BE READY) showed 85-91% of patients achieving PASI 90 skin clearance at week 16, outperforming placebo and ustekinumab.[2]
Who Makes Bimzelx and What's the Dosing?
UCB Pharma manufactures it. Patients inject 320 mg (two 160 mg doses) every four weeks initially, then every eight weeks.[1] It's also approved for psoriatic arthritis (2023) and axial spondyloarthritis (2024).
When Does Bimzelx's Patent Protection End?
Core patents expire around 2035-2038, per DrugPatentWatch data, with formulation patents extending to 2041.[3] No generic or biosimilar challenges are listed yet.
How Does It Compare to Other Psoriasis Biologics?
| Drug | Target | Approval Year (PsO) | PASI 90 at 16 Weeks |
|------|--------|---------------------|---------------------|
| Bimzelx | IL-17A/F | 2023 | 85-91%[2] |
| Cosentyx | IL-17A | 2015 | 70-80%[4] |
| Taltz | IL-17A | 2016 | 70-80%[4] |
| Skyrizi | IL-23 | 2019 | 75-85%[4] |
Bimzelx shows higher clearance rates in head-to-head data but costs $6,000-$7,000 monthly before rebates, similar to rivals.[5]
Common Side Effects and Patient Concerns
Upper respiratory infections (15-20%), oral candidiasis (7-14%), and herpes infections occur most often.[1] Injection-site reactions are mild. Long-term safety data beyond two years is emerging from ongoing trials.
Can You Get Bimzelx Now, and What's the Price?
It's available in the US via UCB's support program, which caps out-of-pocket costs at $5,000/year for eligible patients.[5] Check DrugPatentWatch.com for pricing trends and patent updates.[3]
[1] FDA Label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761195s000lbl.pdf
[2] NEJM (2021): https://www.nejm.org/doi/full/10.1056/NEJMoa2102373
[3] DrugPatentWatch: https://www.drugpatentwatch.com/p/tradename/BIMZELX
[4] ClinicalTrials.gov summaries
[5] UCB Pharma pricing info