Drug Submission Requirements Checklist for Biosimilars (Category 1 and 2) to the BC Ministry of Health

Category 1 Documents and Information Required for Biosimilars Reviewed by the Canadian Agency for Drug and Technologies in Health (CADTH) Common Drug Review (CDR) and by the BC Ministry of Health

Category 1 biosimilar documents and information are required by the CDR review team, the Canadian Drug Expert Committee (CDEC), and the BC Ministry of Health for drug submission review and recommendation processes.

A biosimilar is a biologic drug that enters the Canadian market subsequent to a biologic already authorized in Canada or an authorized non-Canadian biologic drug from a jurisdiction that has an established relationship with Health Canada (i.e., a “reference product”), with which it demonstrates a high degree of similarity.

When submitting Category 1 documents and information for biosimilar products, drug submission sponsors must:

  • Include Ministry-specific Category 1 biosimilar documents in the submission to the Ministry of Health
  • Follow and meet the required Category 1 biosimilar document requirements, as listed in the CADTH Common Drug Review Procedure and Submission Guidelines for Biosimilars (PDF)
  • Send the complete drug submission package of CDR Category 1 biosimilar documents to the Ministry of Health at the same time as they submit their drug submission package to the CDR
  • Submit one copy of the complete submission requirements on a USB flash drive to the Ministry of Health. The USB flash drive should be unlocked and fully executable. Hard/paper copies of drug submissions are no longer accepted
  • Read and follow the checklist of required documents below to ensure the submission package is complete
  • Send the complete drug submission package of CDR and Ministry-specific Category 1 biosimilar documents to the courier address below:

Courier Packages to:

Director, Formulary Management
Pharmaceutical Services Division
BC Ministry of Health
1515 Blanshard Street
Victoria BC  V8W 3C8

Regular Correspondence to:

Director, Formulary Management
Pharmaceutical Services Division
BC Ministry of Health
PO BOX 9652 STN PROV GOVT
Victoria BC  V8W 9P4

Below are detailed checklist of Category 1 biosimilar documents required by the Ministry of Health and the CDR.

Note:

  • All letters submitted specifically to the Ministry of Health, unless otherwise stated in the checklist, must be prepared on company letterhead, signed by an appropriate senior official, and submitted as an electronic copy
  • Send the complete drug submission package of biosimilar documents to the Ministry of Health at the same time as the package is submitted to the CDR
  • Documents required by the CDR (e.g., letters) should be addressed to the CDR
  • Documents required by the Ministry of Health (e.g., letters) should be addressed to the Director of Formulary Management at the Ministry of Health
  • Only complete drug submission packages that follow the checklist criteria and that include all checklist documents will be reviewed
  • NEW: If BC-specific Category 1 biosimilar documents are not ready at the time CDR Category 1 documents are submitted, then the BC specific Category 1 documents can be sent later when the BC-specific and CDR Category 2 documents are submitted
  • Drug submission sponsors are not required to send any Category 1 biosimilar documents that are specific to the Ministry of Health to the CDR.
  • If you have any questions about specific drug submissions, or the drug submission process, send an email to the Ministry of Health Formulary Management team at: DrugReviewProcess@gov.bc.ca


Checklist of required Category 1 biosimilar documents specific to the Ministry of Health

  • Submit all documents to the Ministry of Health electronically. Do not submit as hard/paper copy.
  • Documents with *Signature Required* must be signed by an appropriate senior official.
  • Documents may be signed using an e-signature. When printing hard copies to sign and scan, use blue ink. 
  • Some documents must be submitted in multiple electronic formats (e.g., *Submit as PDF and Excel*).
General Documentation

❏ Cover letter    *Signature Required*

The cover letter, printed on company letterhead and signed by an appropriate senior official, should identify:

  • the type of drug submission to be reviewed
  • each indication, strength and the Drug Identification Number (DIN) to be reviewed
  • the name of each vendor/associate company working on the submission
  • contact information for the primary and backup person who can be contacted regarding the submission under review.

❏ Letter confirming that written notification of any future changes will be provided    *Signature Required*

The letter should be printed on company letterhead and signed by an appropriate senior official.

❏ Letter confirming the availability of the drug pre-NOC  *Signature Required*

The letter should be printed on company letterhead and signed by an appropriate senior official.

❏ Letter confirming ability to supply for anticipated demand  *Signature Required*

The letter should be printed on company letterhead and signed by an appropriate senior official.

❏ Letter confirming that Periodic Safety Update Reports submitted to Health  Canada will also be submitted to the Ministry of Health  *Signature Required*

The letter should be printed on company letterhead and signed by an appropriate senior official.

❏ Letter declaring that all known unpublished studies have been disclosed  *Signature Required*

The letter should be printed on company letterhead and signed by an appropriate senior official.

❏ Table of all known ongoing trials for indications different than the indication being submitted for review

Access applicable information and templates from:

❏ Letter of consent authorizing unrestricted communication and sharing of information  *Signature Required*

The letter, printed on company letterhead and signed by an appropriate senior official, authorizes the Ministry of Health to share information with respect to the drug product under review, with:

  • Health Canada
  • Other provinces and territories
  • CADTH/CDR (Canadian Agency for Drugs and Technologies in Health/Common Drug Review)
  • PMPRB
  • Health authorities including regional health authorities
  • Contracted third party reviewers who are subject to a signed confidentiality agreement.

❏ All Pharmaceutical Advertising Advisory Board (PAAB)-approved promotional materials or draft copies of materials submitted to PAAB


Checklist of required Category 1 biosimilar documents specific to the CDR

  • Submit all documents to the Ministry of Health electronically. Do not submit as hard/paper copy.
  • Some documents must be signed by an appropriate senior official (e.g., *Signature Required*) or submitted in multiple electronic formats (e.g., *Submit as PDF and Excel*).

Category 1 Requirements for a CDR Biosmilar Submission Filed on a Pre-NOC Basis

General Documentation

❏ Completed CDR application overview template

❏ Cover letter  *Signature Required*

❏ Declaration letter for a biosimilar

❏ Product monograph

Health Canada Documentation

At the time of filing:

❏ A placeholder document specifying the anticipated NOC date for the indication(s) to be reviewed by CDR

After NOC or NOC/c is issued:

❏ NOC or Notice of Compliance with conditions (NOC/c)

❏ Letter of Undertaking (only if NOC/c granted)

 Submission Template

At the time of filing:

❏ Completed biosimilar submission template

After NOC or NOC/c is issued:    

❏ Updated biosimilar submission template

Evidence of Switching

❏ Table of studies

❏ Copies of published studies

Pricing and Distribution Documentation

❏ Summary list and/or table on the unit price for all dosage forms, strengths and package sizes, to four decimal places

❏ Method of distribution

Category 1 Requirements for a CDR Biosmilar Submission Filed on a Post-NOC Basis

General Documentation

❏ Completed CDR application overview template

❏ Cover letter  *Signature Required*

❏ Declaration letter for a biosimilar

❏ Product monograph

Health Canada Documentation

❏ NOC or Notice of Compliance with conditions (NOC/c)

Letter of Undertaking (only if NOC/c granted)

Submission Template

  Completed biosimilar submission template

Evidence of Switching

Table of studies

❏ Copies of published studies

Pricing and Distribution Documentation

❏ Summary list and/or table on the unit price for all dosage forms, strengths and package sizes, to four decimal places

❏ Method of distribution

Important: The Ministry of Health reserves the right to ask for additional information as required. The drug submission sponsor must submit any required electronic documentation in accordance with copyright permissions. 

Category 2 Documents and Information Required for Biosimilars Reviewed by the Canadian Agency for Drug and Technologies in Health (CADTH) Common Drug Review (CDR) and by the BC Ministry of Health

Category 2 biosimilar documents and information are required by Canadian drug plans only, including the Ministry of Health, for drug submission review and recommendation processes. CADTH provides secretariat support to the drug plans by gathering Category 2 requirements and ensuring that the documents are complete. The CDR does not use Category 2 documents and information as part of their review and recommendation processes.

When submitting Category 2 documents and information for biosimilar products, drug submission sponsors must:

  • Include Ministry-specific Category 2 documents in the submission to the Ministry of Health
  • Follow and meet the required Category 2 biosimilar document requirements, as listed in the CADTH Common Drug Review Procedure and Submission Guidelines for Biosimilars (PDF)
  • Send the complete drug submission package of CDR Category 2 documents to the Ministry of Health at the same time as they submit their drug submission package to the CDR. The Ministry does not accept hard/paper copies of drug submissions. The Ministry requires one electronic copy of their complete submission on a USB flash drive that is unlocked and fully executable to the Ministry.
  • Read and follow the checklist of required documents below to ensure the submission package is complete
  • Send the complete drug submission package of CDR and Ministry-specific Category 2 documents to the courier address below:

Courier Packages to:

Director, Formulary Management
Pharmaceutical Services Division
BC Ministry of Health
1515 Blanshard Street
Victoria BC  V8W 3C8

Regular Correspondence to:

Director, Formulary Management
Pharmaceutical Services Division
BC Ministry of Health
PO BOX 9652 STN PROV GOVT
Victoria BC  V8W 9P4

Below are detailed checklist of Category 2 documents required by the Ministry of Health and the CDR.


Checklist of required Category 2 documents specific to the Ministry of Health

  • Submit all documents to the Ministry of Health electronically. Do not submit as hard/paper copy.
  • Documents with *Signature Required* must be signed by an appropriate senior official.
  • Documents may be signed using an e-signature. When printing hard copies to sign and scan, use blue ink.
  • Some documents must be submitted in multiple electronic formats (e.g., *Submit as PDF and Excel*).
General Documentation

❏ Drug Product Request Form for Biosimilars

*Applies to Common Drug Review (CDR) Submissions Only* 

Access and complete the Ministry of Health Drug Product Request Form for CDR Submissions (DOCX) as a Word document. In the template, include the following:

  • Each indication, strength and the Drug Identification Number (DIN) to be reviewed.
  • The name of the drug manufacturer and each vendor/associate company working on the submission.
  • Contact information for the primary and backup person who can be contacted regarding the submission.
  • A high-level executive summary describing the submission.


Checklist for required Category 2 documents specific to the CDR

  • Submit all documents to the Ministry of Health electronically. Do not submit as hard/paper copy.
  • Some documents must be signed by an appropriate senior official (e.g., *Signature Required*) or submitted in multiple electronic formats (e.g., *Submit as PDF and Excel*).
Budget Impact Analysis and Supporting Documentation

❏ Budget Impact Analysis (BIA)  (Reports and Models) *Submit as PDF and Excel*

  • Include BIAs (reports and models) for the following jurisdictions’ drug plans: British Columbia (BC), Alberta, Saskatchewan, Manitoba, Ontario, New Brunswick, Nova Scotia, Prince Edward Island, Newfoundland and Labrador, and the Non-Insured Health Benefits Program.

❏ Reference list of all supporting documentation used and/or cited in the BIAs

❏ Copies of all supporting documentation used and/or cited in the BIAs

Important: The Ministry of Health reserves the right to ask for additional information as required. The drug submission sponsor must submit any required electronic documentation in accordance with copyright permissions.