Canada’s Drug Agency | Drugs, Health Technologies and Systems.

bimekizumab

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Generic Name:
bimekizumab
Project Status:
Active
Therapeutic Area:
Hidradenitis suppurative
Manufacturer:
UCB Canada Inc.
Call for patient/clinician input open:
Brand Name:
Bimzelx
Project Line:
Reimbursement Review
Project Number:
SR0856-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with moderate to severe hidradenitis suppurativa who have inadequate response to conventional systemic therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​For the treatment of adult patients with moderate to severe hidradenitis suppurativa
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input open06-Sep-24
Call for patient/clinician input closed04-Nov-24
Submission received18-Oct-24
Submission accepted01-Nov-24
Review initiated04-Nov-24
Draft CADTH review report(s) provided to sponsor for comment06-Feb-25
Deadline for sponsors comments18-Feb-25
CDA-AMC review report(s) and responses to comments provided to sponsor13-Mar-25
Expert committee meeting (initial)26-Mar-25
Draft recommendation issued to sponsor-
Clarification:

- CDEC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements.

Draft recommendation posted for stakeholder feedback-
End of feedback period-

Files

Patient and Clinician Group input View PDF
Last Updated : April 14, 2025