insulin glargine

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Generic Name:
insulin glargine
Project Status:
Withdrawn
Therapeutic Area:
Diabetes mellitus, Type 1 & 2
Manufacturer:
BGP PHARMA ULC
Call for patient/clinician input open:
Brand Name:
Semglee
Project Line:
Reimbursement Review
Project Number:
SE0589-000
Call for patient/clinician input closed:
Biosimilar:
Yes
Manufacturer Requested Reimbursement Criteria1:
To be listed as the preferred insulin glargine treatment for patients who have been diagnosed with type 1 or type 2 diabetes requiring long-acting insulin.
Submission Type:
Initial
Fee Schedule:
Schedule D
Indications:
Diabetes mellitus, Type 1 & 2
  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 input postedOctober 16, 2018
Patient group input closedDecember 04, 2018
Clarification:

- Patient input submission received from Diabetes Canada

Patient input summary sent for review to patient input groupsDecember 12, 2018
Patient group comments on input summary closedDecember 19, 2018
Clarification:

- Patient input summary feedback received

Submission receivedNovember 14, 2018
Submission accepted for reviewNovember 29, 2018
Clarification:

- Submission was not accepted for review on 21 Nov 2018

Review initiatedNovember 30, 2018
Clarification:

- Voluntarily withdrawn by the manufacturer on 2019-Mar-05