Drug and Health Product Submissions Under Review (SUR): Supplemental submissions under review

This list is current as of: 2026-03-31.

An Excel version of the updated SUR List is available from the Overview page.

Submissions currently under review: Supplemental new drug submissions for new uses
Medicinal Ingredient(s) Therapeutic Area Year, Month Submission was Accepted into Review Company Name (available for submissions accepted into review on or after October 1, 2018) Submission 'Class' (if applicable) (available for submissions accepted into review on or after October 1, 2018)
Acalabrutinib maleate Antineoplastic agents 2025-12 AstraZeneca Canada Inc Part of an 'aligned review' with a health technology assessment organization
Adalimumab Immunosuppressants 2024-09 JAMP Pharma Corporation Biosimilar
Aflibercept Ophthalmologicals 2025-12 Bayer Inc Not applicable
Alirocumab Lipid modifying agents 2024-12 Sanofi-Aventis Canada Inc Not applicable
Amivantamab Antineoplastic agents 2025-08 Janssen Inc Not applicable
Atezolizumab Antineoplastic agents 2025-09 Hoffmann-la Roche Limited Not applicable
Avapritinib Antineoplastic agents 2025-05 Blueprint Medicines Corporation

Being reviewed under the Priority Review Policy

Part of an 'aligned review' with a health technology assessment organization

Baricitinib Immunosuppressants 2026-03 Eli Lilly Canada Inc Not applicable
Belzutifan Antineoplastic agents 2025-12 Merck Canada Inc Not applicable
Belzutifan Antineoplastic agents 2026-03 Merck Canada Inc Not applicable
Benralizumab Drugs for obstructive airway diseases 2025-10 AstraZeneca Canada Inc Not applicable
Berotralstat hydrochloride Other hematological agents 2026-03 Biocryst Pharmaceuticals Inc Part of an 'aligned review' with a health technology assessment organization
Brexpiprazole Psycholeptics 2026-03 Otsuka Pharmaceutical Co Ltd Not applicable
Budesonide, formoterol fumarate dihydrate, glycopyrronium bromide Drugs for obstructive airway diseases 2025-10 AstraZeneca Canada Inc Not applicable
Cemiplimab Antineoplastic agents 2025-08 Regeneron Canada Company Not applicable
Coagulation factors II (human), IX (human), VII (human), X (human), proteins C, S Antihemorrhagics 2025-10 Octapharma Pharmazeutika Produktionsges M B H Not applicable
Corynebacterium diphtheriae CRM-197 protein, pneumococcal conjugate serotype 33F, pneumococcal polysaccharide serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, deOAc15B, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 35B Vaccines 2025-11 Merck Canada Inc Not applicable
Daratumumab Antineoplastic agents 2025-12 Janssen Inc Not applicable
Drospirenone, estetrol monohydrate Sex hormones and modulators of the genital system 2025-11 Searchlight Pharma Inc Not applicable
Dupilumab Other dermatological preparations 2025-11 Sanofi-Aventis Canada Inc Not applicable
Dupilumab Other dermatological preparations 2026-01 Sanofi-Aventis Canada Inc Not applicable
Dupilumab Other dermatological preparations 2026-02 Sanofi-Aventis Canada Inc Not applicable
Durvalumab Antineoplastic agents 2025-10 AstraZeneca Canada Inc Part of an 'aligned review' with a health technology assessment organization
Elinzanetant Other gynecologicals 2025-10 Bayer Inc Not applicable
Enfortumab vedotin Antineoplastic agents 2025-12 Pfizer Canada ULC

Being reviewed under the Priority Review Policy

Part of an 'aligned review' with a health technology assessment organization

Epcoritamab Antineoplastic agents 2026-03 Abbvie Corporation

Being reviewed under the Priority Review Policy

Part of an 'aligned review' with a health technology assessment organization

Fish oil, medium-chain triglycerides, olive oil, soybean oil Blood substitutes and perfusion solutions 2025-11 Fresenius Kabi Canada Ltd Not applicable
Guselkumab Immunosuppressants 2025-01 Janssen Inc Not applicable
Inebilizumab Immunosuppressants 2025-07 Amgen Canada Inc Not applicable
Iopromide Contrast media 2025-12 Bayer Inc Being reviewed under the Submissions Relying on Third-Party Data Guidance
Ipilimumab Antineoplastic agents 2025-11 Bristol-Myers Squibb Canada Not applicable
Iptacopan hydrochloride Immunosuppressants 2025-07 Novartis Pharmaceuticals Canada Inc Part of an 'aligned review' with a health technology assessment organization
Isatuximab Antineoplastic agents 2025-08 Sanofi-Aventis Canada Inc Part of an 'aligned review' with a health technology assessment organization
Larotrectinib sulfate Antineoplastic agents 2025-11 Bayer Inc Not applicable
Lisocabtagene maraleucel Antineoplastic agents 2026-03 Bristol-Myers Squibb Canada Not applicable
Lurbinectedin Antineoplastic agents 2025-08 Jazz Pharmaceuticals Ireland Limited Not applicable
Mepolizumab Drugs for obstructive airway diseases 2025-01 GlaxoSmithKline Inc Part of an 'aligned review' with a health technology assessment organization
Nivolumab Antineoplastic agents 2025-11 Bristol-Myers Squibb Canada Not applicable
Ocrelizumab Immunosuppressants 2026-01 Hoffmann-la Roche Limited Not applicable
Pegcetacoplan Immunosuppressants 2025-10 Swedish Orphan Biovitrum AB (Publ)

Being reviewed under the Priority Review Policy

Part of an 'aligned review' with a health technology assessment organization

Peginterferon alfa-2a Immunostimulants 2026-02 Pharmaand GmbH Not applicable
Pembrolizumab Antineoplastic agents 2025-11 Merck Canada Inc Being reviewed under the Priority Review Policy
Pembrolizumab Antineoplastic agents 2025-12 Merck Canada Inc

Being reviewed under the Priority Review Policy

Part of an 'aligned review' with a health technology assessment organization

Pembrolizumab Antineoplastic agents 2026-03 Merck Canada Inc Not applicable
Pirtobrutinib Antineoplastic agents 2026-01 Eli Lilly Canada Inc Not applicable
Pirtobrutinib Antineoplastic agents 2026-03 Eli Lilly Canada Inc Not applicable
Respiratory syncytial virus prefusion F protein (RSVPreF3) Vaccines 2026-01 GlaxoSmithKline Inc Not applicable
Retifanlimab Antineoplastic agents 2025-08 Incyte Corporation Part of an 'aligned review' with a health technology assessment organization
Risankizumab Immunosuppressants 2025-12 Abbvie Corporation Not applicable
Ritonavir Antivirals for systemic use 2026-01 Abbvie Corporation Not applicable
Roflumilast Antipsoriatics 2025-10 Arcutis Canada, Inc. Not applicable
Roflumilast Antipsoriatics 2026-02 Arcutis Canada, Inc. Not applicable
Sacituzumab govitecan Antineoplastic agents 2026-01 Gilead Sciences Canada Inc Part of an 'aligned review' with a health technology assessment organization
Sacituzumab govitecan Antineoplastic agents 2026-01 Gilead Sciences Canada Inc Part of an 'aligned review' with a health technology assessment organization
Selumetinib sulfate Antineoplastic agents 2025-09 Alexion Pharma GmbH Not applicable
Semaglutide Drugs used in diabetes 2025-04 Novo Nordisk Canada Inc Not applicable
Semaglutide Drugs used in diabetes 2026-01 Novo Nordisk Canada Inc Not applicable
Setmelanotide acetate Antiobesity preparations, excluding diet products 2026-03 Rhythm Pharmaceuticals, Inc

Being reviewed under the Priority Review Policy

Part of an 'aligned review' with a health technology assessment organization

Tafasitamab Antineoplastic agents 2025-06 Incyte Corporation Part of an 'aligned review' with a health technology assessment organization
Tapinarof Antipsoriatics 2025-10 Organon Canada Inc. Not applicable
Tarlatamab Antineoplastic agents 2025-09 Amgen Canada Inc Not applicable
Teclistamab Antineoplastic agents 2026-02 Janssen inc Being reviewed under the Priority Review Policy
Tirzepatide Drugs used in diabetes 2025-08 Eli Lilly Canada Inc Part of an 'aligned review' with a health technology assessment organization
Tirzepatide Drugs used in diabetes 2025-08 Eli Lilly Canada Inc Not applicable
Tirzepatide Drugs used in diabetes 2025-12 Eli Lilly Canada Inc Not applicable
Tirzepatide Antineoplastic agents 2026-02 Eli Lilly Canada Inc Not applicable
Trastuzumab deruxtecan Antineoplastic agents 2026-02 AstraZeneca Canada Inc Part of an 'aligned review' with a health technology assessment organization
Trastuzumab deruxtecan Antineoplastic agents 2026-03 AstraZeneca Canada Inc

Being reviewed under the Priority Review Policy

Part of an 'aligned review' with a health technology assessment organization

Trastuzumab deruxtecan Antineoplastic agents 2026-03 AstraZeneca Canada Inc Not applicable
Upadacitinib Immunosuppressants 2026-02 Abbvie Corporation Not applicable
Ustekinumab Immunosuppressants 2026-02 Janssen Inc Not applicable
Venetoclax Antineoplastic agents 2025-08 Abbvie Corporation Not applicable

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2026-04-30