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guselkumab

Last Updated: September 14, 2017
Result type: Reports
Project Number: SR0530-000
Product Line: Common Drug Review

Generic Name: guselkumab

Brand Name: TBC

Manufacturer: Janssen Inc.

Indications: Psoriasis, moderate to severe plaque

Submission Type: New

Project Status: Active

Biosimilar: No

Fee Schedule1: Schedule A

Key Milestones2

Call for patient input posted327-Jul-17
Patient group input closed318-Sep-17
Patient input summary sent for review to patient input groups-
Patient group comments on input summary closed-
Submission received25-Aug-17
Submission accepted for review11-Sep-17
Review initiated12-Sep-17
Draft CDR review report(s) sent to applicant24-Nov-17
Comments from applicant on draft CDR review report(s) received05-Dec-17
Redaction requests from applicant on draft CDR review report(s) received12-Dec-17
CDR review team's comments on draft CDR review report(s) sent to applicant05-Jan-18
Canadian Drug Expert Committee (CDEC) meeting17-Jan-18
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansJanuary 29, 2018
To
January 31, 2018
  1. Refer to Appendix 1 of the Procedure for the CADTH Common Drug Review for details regarding CDR application fee schedules.
  2. Please refer to the Procedure for the CADTH Common Drug Review for complete details regarding the CDR process and targeted time frames for key milestones.
  3. The call for patient group input is posted 20 business days in advance of the applicant's anticipated date of filing the CDR application. Patient groups have a total of 35 business days for preparing and submitting patient input.
  4. The embargoed CDEC recommendation is held in confidence by all stakeholders and not acted upon until after CADTH has issued the notice of CDEC Final Recommendation.The applicant may make a request for reconsideration or resubmission based on reduced price during the embargo period, and the drug plans may make a request for clarification, as applicable (see section 8 of the Procedure for the CADTH Common Drug Review).
  5. The timing for posting the CDEC Final Recommendation and CDR review report(s) depends on several factors including the need for consultation with the applicant regarding redaction issues.
  6. The time frame required to address a request for clarification at the drug plans' request or request for reconsideration at the applicant's request depends on the amount of work required to address the request and the available dates for CDEC meetings.