Drug and Health Product Submissions Under Review (SUR): New drug submissions under review
This list is current as of: 2025-07-31.
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) |
|---|---|---|---|---|
| Afamelanotide | Emollients and protectives | 2024-12 | Clinuvel, Inc. | New active substance |
| Aflibercept | Ophthalmologicals | 2023-09 | Celltrion Inc | Biosimilar Part of 'aligned review' with a health technology assessment organization |
| Aflibercept | Ophthalmologicals | 2024-07 | Samsung Bioepis Co., Ltd | Biosimilar |
| Aflibercept | Ophthalmologicals | 2025-01 | Formycon AG | Biosimilar |
| Aflibercept | Ophthalmologicals | 2025-01 | Sandoz Canada Incorporated | Biosimilar |
| Aflibercept | Ophthalmologicals | 2025-07 | JAMP Pharma Corporation | Biosimilar Part of 'aligned review' with a health technology assessment organization |
| Aprocitentan | Antihypertensives | 2025-01 | Idorsia Pharmaceuticals Ltd | New active substance |
| Aripiprazole | Psycholeptics | 2024-09 | Odan Laboratories Ltd | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Atrasentan hydrochloride | Agents acting on the renin-angiotensin system | 2025-07 | Novartis Pharmaceuticals Canada Inc | New active substance |
| Avacincaptad pegol | Ophthalmologicals | 2025-02 | Astellas Pharma Canada Inc | New active substance Part of 'aligned review' with a health technology assessment organization |
| Axatilimab | Immunosuppressants | 2025-01 | Incyte Corporation | New active substance |
| Bempedoic acid | Lipid modifying agents | 2025-01 | Esperion Therapeutics, Inc | New active substance |
| Bempedoic acid, ezetimibe | Lipid modifying agents | 2025-01 | Esperion Therapeutics, Inc | Not applicable |
| Betamethasone dipropionate, calcipotriol monohydrate | Antipsoriatics | 2025-07 | Glenmark Pharmaceuticals Canada Inc. | Not applicable |
| Benzoyl peroxide | Anti-acne preparations | 2024-09 | Searchlight Pharma Inc | Not applicable |
| Benzoyl peroxide, tretinoin | Anti-acne preparations | 2025-02 | Searchlight Pharma Inc | Not applicable |
| Betamethasone dipropionate, calcipotriol | Antipsoriatics | 2025-01 | MC2 Therapeutics Ltd | Not applicable |
| Bevacizumab | Antineoplastic agents | 2025-06 | Curateq Biologics Private Limited | Biosimilar Part of 'aligned review' with a health technology assessment organization |
| Bulevirtide acetate | Antivirals for systemic use | 2025-02 | Gilead Sciences Canada Inc | New active substance Being reviewed under the Priority Review Policy Part of 'aligned review' with a health technology assessment organization |
| Carbidopa, levodopa | Anti-parkinson drugs | 2025-07 | Knight Therapeutics Inc. | Not applicable |
| Ceftaroline fosamil | Antibacterials for systemic use | 2025-07 | Sterimax Inc. | New active substance Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Chikungunya virus virus-like particle (CHIKV VLP) | Vaccines | 2025-07 | Bavarian Nordic AS | New active substance |
| Chloroprocaine hydrochloride | Ophthalmologicals | 2025-02 | Apotex Inc | Part of 'aligned review' with a health technology assessment organization |
| Cilastatin sodium, imipenem, relebactam | Antibacterials for systemic use | 2025-05 | Merck Canada Inc | New active substance Being reviewed under the Priority Review Policy |
| Clesrovimab | Immune sera and immunoglobulins | 2025-04 | Merck Canada Inc | New active substance |
| Clobetasol propionate | Ophthalmologicals | 2025-03 | Apotex Inc | Part of 'aligned review' with a health technology assessment organization |
| Cyclophosphamide, cyclophosphamide monohydrate | Antineoplastic agents | 2023-08 | Dr Reddys Laboratories Ltd | Not applicable |
| Cyclosporine | Ophthalmologicals | 2025-01 | Apotex Inc | Not applicable |
| Cysteamine hydrochloride | Ophthalmologicals | 2024-05 | Leadiant Biosciences, Inc. | Part of 'aligned review' with a health technology assessment organization |
| Delgocitinb | Other dermatological preparations | 2024-02 | Leo Pharma Inc | New active substance Part of 'aligned review' with a health technology assessment organization |
| Denosumab | Drugs for treatment of bone diseases | 2024-05 | Celltrion Inc |
Biosimilar Part of 'aligned review' with a health technology assessment organization |
| Denosumab | Drugs for treatment of bone diseases | 2024-05 | Celltrion Inc |
Biosimilar Part of 'aligned review' with a health technology assessment organization |
| Denosumab | Drugs for treatment of bone diseases | 2024-05 | Samsung Bioepis Co., Ltd | Biosimilar |
| Denosumab | Drugs for treatment of bone diseases | 2024-05 | Samsung Bioepis Co., Ltd | Biosimilar |
| Denosumab | Drugs for treatment of bone diseases | 2024-07 | Mantra Pharma Inc. | Biosimilar |
| Denosumab | Drugs for treatment of bone diseases | 2024-09 | Shanhai Henlius Biotech, Inc. | Biosimilar |
| Denosumab | Drugs for treatment of bone diseases | 2024-09 | Shanhai Henlius Biotech, Inc. | Biosimilar |
| Denosumab | Drugs for treatment of bone diseases | 2024-10 | Biosimilar Collaborations Ireland Limited | Biosimilar Part of 'aligned review' with a health technology assessment organization |
| Denosumab | Drugs for treatment of bone diseases | 2024-10 | Biosimilar Collaborations Ireland Limited | Biosimilar Part of 'aligned review' with a health technology assessment organization |
| Denosumab | Drugs for treatment of bone diseases | 2024-11 | Apotex Inc | Biosimilar Part of 'aligned review' with a health technology assessment organization |
| Denosumab | Drugs for treatment of bone diseases | 2024-11 | Apotex Inc | Biosimilar Part of 'aligned review' with a health technology assessment organization |
| Denosumab | Drugs for treatment of bone diseases | 2025-06 | Fresenius Kabi Canada Ltd | Biosimilar |
| Denosumab | Drugs for treatment of bone diseases | 2025-06 | Fresenius Kabi Canada Ltd | Biosimilar |
| Depemokimab | Drugs for obstructive airway diseases | 2025-04 | GlaxoSmithKline Inc | New active substance Part of 'aligned review' with a health technology assessment organization |
| Donanemab | Psychoanaleptics | 2024-02 | Eli Lilly Canada Inc | New active substance Part of 'aligned review' with a health technology assessment organization |
| Doxycycline hyclate | Antibacterials for systemic use | 2025-01 | Sterimax Inc | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Eculizumab | Immunosuppressants | 2022-07 | Amgen Canada Inc | Biosimilar Part of 'aligned review' with a health technology assessment organization |
| Eculizumab | Immunosuppressants | 2023-05 | Amgen Canada Inc | Biosimilar Part of 'aligned review' with a health technology assessment organization |
| Eculizumab | Immunosuppressants | 2023-07 | Samsung Bioepis Co., Ltd | Biosimilar |
| Epinephrine | Drugs for obstructive airway diseases | 2025-02 | ARS Pharmaceuticals Operations, Inc. | Part of 'aligned review' with a health technology assessment organization |
| Gadopiclenol | Contrast media | 2025-04 | Bracco Imaging Canada | New active substance |
| Garadacimab | Antithrombotic agents | 2023-12 | CSL Behring Canada Inc | New active substance |
| Glucagon | Pancreatic hormones | 2024-11 | Lupin Pharma Canada Limited | Not applicable |
| Golimumab | Immunosuppressants | 2025-06 | JAMP Pharma Corporation | Biosimilar Part of 'aligned review' with a health technology assessment organization |
| Imlunestrant tosylate | Antineoplastic agents | 2025-02 | Eli Lilly Canada Inc | New active substance Part of an 'aligned review' with a health technology assessment organization |
| Latanoprost | Ophthalmologicals | 2025-01 | Orimed Pharma Inc | Not applicable |
| Latanoprost, timolol maleate | Ophthalmologicals | 2025-01 | Orimed Pharma Inc | Not applicable |
| Lecanemab | Psychoanaleptics | 2023-05 | Eisai Limited | New active substance Part of an 'aligned review' with a health technology assessment organization |
| Lenacapavir sodium | Antivirals for systemic use | 2025-06 | Gilead Sciences Canada Inc | Part of an 'aligned review' with a health technology assessment organization |
| Leniolisib | Immunostimulants | 2023-10 | Pharming Technologies BV | New active substance Being reviewed under the Priority Review Policy Part of 'aligned review' with a health technology assessment organization |
| Leuprolide mesylate | Endocrine therapy | 2025-06 | Accord Healthcare Inc | Part of an 'aligned review' with a health technology assessment organization |
| Levothyroxine sodium | Thyroid therapy | 2025-07 | Biosyent Pharma Inc | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Lifileucel | Antineoplastic agents | 2025-01 | Iovance Biotherapeutics, Inc | New active substance Being reviewed under the Notice of Compliance with Conditions Guidance |
| Melatonin | Psychleptics | 2024-08 | Neurim Pharmaceuticals Ltd. | Not applicable |
| Metformin hydrochloride | Drugs used in diabetes | 2025-05 | Pharmaris Canada Inc | Not applicable |
| Methohexital sodium | Anesthetics | 2024-09 | Sterimax Inc | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
| Mirvetuximab soravtansine | Antineoplastic agents | 2025-03 | Abbvie Corporation | New active substance Being reviewed under the Priority Review Policy Part of 'aligned review' with a health technology assessment organization |
| Mosunetuzumab | Antineoplastic agents | 2025-06 | Hoffmann-La Roche Limited | New active substance Being reviewed under the Notice of Compliance with Conditions Guidance |
| mRNA encoding SARS-CoV-2 spike protein NTD-RBD subdomains | Vaccines | 2024-12 | Moderna Biopharma Canada Corporation | New active substance For use in relation to COVID-19 |
| Nadofaragene firadenovec | Antineoplastic agents | 2025-04 | Ferring Inc | New active substance Part of ‘aligned review’ with a health technology assessment organization |
| Natalizumab | Immunosuppressants | 2024-06 | Polpharma Biologics S.A. | Biosimilar |
| Nemolizumab | Other dermatological preparations | 2024-06 | Galderma Canada Inc. | New active substance Part of ‘aligned review’ with a health technology assessment organization |
| Nipocalimab | Immunosuppressants | 2025-01 | Janssen inc | New active substance |
| Olezarsen sodium | Lipid modifying agents | 2025-06 | Theratechnologies Inc | New active substance Being reviewed under the Priority Review Policy Part of ‘aligned review’ with a health technology assessment organization |
| Oritavancin diphosphate | Antibacterials for systemic use | 2024-08 | Xediton Pharmaceuticals Inc | New active substance Being reviewed under the Priority Review Policy |
| Palopegteriparatide | Calcium homeostasis | 2025-03 | Pendopharm Division of Pharmascience Inc | New active substance |
| Pegfilgrastim | Immunostimulants | 2025-03 | Curateq Biologics Private Limited | Biosimilar |
| Pegunigalsidase alfa | Other alimentary tract and metabolism products | 2024-11 | Chiesi Farmaceutici S.P.A. | New active substance |
| Pertuzumab | Antineoplastic agents | 2025-05 | Shanghai Henlius Biotech, Inc. | Biosimilar |
| Pirtobrutinib | Antineoplastic agents | 2025-03 | Eli Lilly Canada Inc | New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of ‘aligned review’ with a health technology assessment organization |
| Plozasiran | Lipid modifying agents | 2025-07 | Arrowhead Pharmaceuticals, Inc. | New active substance Being reviewed under the Priority Review Policy |
| Pregabalin | Analgesics | 2025-01 | Orimed Pharma Inc | Being reviewed under the Submissions Relying on Third-Party Data Guidance Part of ‘aligned review’ with a health technology assessment organization |
| Pregabalin | Analgesics | 2025-02 | Odan Laboratories Ltd | Not applicable |
| Rifapentine | Antimycobacterials | 2025-03 | Macleods Pharmaceuticals Limited | New active substance Part of ‘aligned review’ with a health technology assessment organization |
| Rituximab | Antineoplastic agents | 2024-02 | Dr. Reddy’s Laboratories SA | Biosimilar Part of ‘aligned review’ with a health technology assessment organization |
| Seladelpar lysine | Bile and liver therapy | 2025-02 | Gilead Sciences Canada Inc | New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of ‘aligned review’ with a health technology assessment organization |
| Sepiapterin | Other alimentary tract and metabolism products | 2024-07 | PTC Therapeutics International Limited | New active substance Being reviewed under the Priority Review Policy |
| Sevabertinib | Antineoplastic agents | 2025-05 | Bayer Inc | New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of ‘aligned review’ with a health technology assessment organization |
| Testosterone undecanoate | Sex hormones and modulators of the genital system | 2024-12 | Marius Pharmaceuticals, LLC | Not applicable |
| Testosterone undecanoate | Sex hormones and modulators of the genital system | 2025-01 | Tolmar International Ltd. | Not applicable |
| Tislelizumab | Antineoplastic agents | 2025-02 | BeOne Medicines I GmbH | New active substance Part of ‘aligned review’ with a health technology assessment organization |
| Tislelizumab | Antineoplastic agents | 2025-06 | Beigene Switzerland GmbH | Not applicable |
| Tocilizumab | Immunosuppressants | 2024-07 | Celltrion Inc | Biosimilar Part of ‘aligned review’ with a health technology assessment organization |
| Tocilizumab | Immunosuppressants | 2024-10 | Biogen Canada Inc | Biosimilar |
| Toripalimab | Antineoplastic agents | 2024-12 | Apotex Inc | New active substance Part of ‘aligned review’ with a health technology assessment organization |
| Trastuzumab | Antineoplastic agents | 2017-11 | Not available | Not available |
| Trastuzumab | Antineoplastic agents | 2017-11 | Not available | Not available |
| Trastuzumab | Antineoplastic agents | 2018-02 | Not available | Not available |
| Ustekinumab | Immunosuppressants | 2024-05 | Accord Healthcare Inc | Biosimilar Part of ‘aligned review’ with a health technology assessment organization |
| Ustekinumab | Immunosuppressants | 2024-05 | Biosimilar Collaborations Ireland Limited | Biosimilar Part of ‘aligned review’ with a health technology assessment organization |
| Vamorolone | Corticosteroids for systemic use | 2025-04 | Kye Pharmaceuticals Inc | New active substance Being reviewed under the Priority Review Policy Part of ‘aligned review’ with a health technology assessment organization |
| Viloxazine hydrochloride | Psychoanaleptics | 2024-12 | Knight Therapeutics Inc. | New active substance |
| Vosoritide | Drugs for treatment of bone diseases | 2025-02 | Biomarin International Limited | New active substance |
| Zanidatamab | Antineoplastic agents | 2025-04 | Jazz Pharmaceuticals Ireland Limited | New active substance Being reviewed under the Notice of Compliance with Conditions Guidance |
| Zuranolone | Psychoanaleptics | 2024-12 | Biogen Canada Inc | New active substance |
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