Drug and Health Product Submissions Under Review (SUR): Supplemental submissions under review
This list is current as of: 2025-08-31.
An Excel version of the updated SUR List is available from the Overview page.
| 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 | 2024-11 | AstraZeneca Canada Inc | Part of an 'aligned review' with a health technology assessment organization |
| Adalimumab | Immunosuppressants | 2024-09 | JAMP Pharma Corporation | Biosimilar |
| Alirocumab | Lipid modifying agents | 2024-12 | Sanofi-Aventis Canada Inc | Not applicable |
| Amivantamab | Antineoplastic agents | 2025-08 | Janssen Inc | Not applicable |
| Antihemophilic factor (recombinant, B-domain deleted, pegylated) | Antihemorrhagics | 2024-12 | Bayer Inc | 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 |
| Belimumab | Immunosuppressants | 2023-11 | GlaxoSmithKline Inc | Not applicable |
| Bimekizumab | Immunosuppressants | 2024-06 | UCB Canada Inc | Part of an 'aligned review' with a health technology assessment organization |
| Cemiplimab | Antineoplastic agents | 2025-08 | Regeneron Canada Company | Not applicable |
| Corynebacterium diphtheriae CRM-197 protein, pneumococcal polysaccharide serotypes 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, 35B, deOAc15B | Vaccines | 2024-11 | Merck Canada Inc | Not applicable |
| Daratumumab | Antineoplastic agents | 2025-01 | Janssen Inc | Part of an 'aligned review' with a health technology assessment organization |
| Dupilumab | Other dermatological preparations | 2024-06 | Sanofi-Aventis Canada Inc | Not applicable |
| Dupilumab | Other dermatological preparations | 2025-01 | Sanofi-Aventis Canada Inc | Not applicable |
| Durvalumab | Antineoplastic agents | 2024-01 | AstraZeneca Canada Inc | Not applicable |
| Durvalumab | Antineoplastic agents | 2025-07 | AstraZeneca Canada Inc | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
| Efgartigimod alfa | Immunsuppressants | 2025-01 | Argenx BV | Part of an 'aligned review' with a health technology assessment organization |
| Finerenone | Diuretics | 2025-03 | Bayer Inc | Part of an 'aligned review' with a health technology assessment organization |
| Fremanezumab | Analgesics | 2025-04 | Teva Canada Limited | Not applicable |
| Glecaprevir, pibrentasvir | Antivirals for systemic use | 2025-06 | Abbvie Corporation | Being reviewed under the Priority Review Policy |
| Guselkumab | Immunosuppressants | 2024-06 | Janssen Inc | Not applicable |
| Guselkumab | Immunosuppressants | 2025-01 | Janssen Inc | Not applicable |
| Guselkumab | Immunosuppressants | 2025-01 | Janssen Inc | Not applicable |
| Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B | Vaccines | 2025-04 | BGP Pharma ULC | Not applicable |
| Inebilizumab | Immunosuppressants | 2025-07 | Amgen Canada Inc | 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 |
| Leuprolide acetate | Endocrine therapy | 2025-01 | Abbvie Corporation | Not applicable |
| Lurbinectedin | Antineoplastic agents | 2025-08 | Jazz Pharmaceuticals Ireland Limited | Not applicable |
| Macitentan | Antihypertensives | 2024-02 | Janssen Inc | Not applicable |
| Maralixibat chloride | Bile and liver therapy | 2025-04 | Mirum Pharmaceuticals, Inc. | Part of an 'aligned review' with a health technology assessment organization |
| Meningococcal groups A, C, Y, and W polysaccharide-tetanus toxoid conjugate | Vaccines | 2025-05 | Sanofi Pasteur 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 | 2024-03 | Bristol-Myers Squibb Canada | Not applicable |
| Obinutuzumab | Antineoplastic agents | 2025-03 | Hoffmann-la Roche Limited | Not applicable Part of an 'aligned review' with a health technology assessment organization |
| Retifanlimab | Antineoplastic agents | 2025-08 | Incyte Corporation | Not applicable |
| Roflumilast | Antipsoriatics | 2025-01 | Arcutis Canada, Inc. | Not applicable |
| RSV F-protein mRNA, 5'(m7G-5'-ppp-5'-Gm), 3' poly(A) | Vaccines | 2025-03 | Moderna Biopharma Canada Corporation | Not applicable |
| RSV subgroups A, B stabilized prefusion F protein | Vaccines | 2024-12 | Pfizer Canada ULC | Not applicable |
| Ruxolitinib phosphate | Other dermatological preparations | 2024-12 | Incyte Corporation | Not applicable |
| Selumetinib sulfate | Antineoplastic agents | 2025-05 | Alexion Pharma GmbH | Not applicable |
| Semaglutide | Drugs used in diabetes | 2024-02 | Novo Nordisk Canada Inc | Not applicable |
| Semaglutide | Drugs used in diabetes | 2025-03 | Novo Nordisk Canada Inc | Not applicable |
| Semaglutide | Drugs used in diabetes | 2025-04 | Novo Nordisk Canada Inc | Not applicable |
| Semaglutide | Drugs used in diabetes | 2025-04 | Novo Nordisk Canada Inc | Being reviewed under the Priority Review Policy |
| Sotatercept | Antihypertensives | 2025-06 | Merck Canada Inc | Being reviewed under the Priority Review Policy |
| Tafasitamab | Antineoplastic agents | 2025-06 | Incyte Corporation | Part of an 'aligned review' with a health technology assessment organization |
| Tenecteplase | Antithrombotic agents | 2024-08 | Hoffmann-la Roche Limited | Not applicable |
| Tezepelumab | Drugs for obstructive airway diseases | 2025-04 | AstraZeneca Canada Inc | Part of an 'aligned review' with a health technology assessment organization |
| Tirzepatide | Drugs used in diabetes | 2025-02 | Eli Lilly Canada Inc | Not applicable |
| Tirzepatide | Drugs used in diabetes | 2025-08 | Eli Lilly Canada Inc | Not applicable |
| Tirzepatide | Drugs used in diabetes | 2025-08 | Eli Lilly Canada Inc | Not applicable |
| Trastuzumab deruxtecan | Antineoplastic agents | 2024-12 | AstraZeneca Canada Inc | Part of an 'aligned review' with a health technology assessment organization |
| Ustekinumab | Immunosuppressants | 2025-07 | Fresenius Kabi Canada Ltd | Biosimilar |
| Venetoclax | Antineoplastic agents | 2025-08 | Abbvie Corporation | Not applicable |
| Vutrisiran sodium | Other nervous system drugs | 2025-02 | Alnylam Netherlands B.V. | Part of an 'aligned review' with a health technology assessment organization |