Drug and Health Product Submissions Under Review (SUR): New drug submissions under review
This list is current as of: 2025-03-31.
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 |
2022-05 |
Biosimilar Collaborations Ireland Limited |
Biosimilar Part of 'aligned review' with a health technology assessment organization |
Aflibercept |
Ophthalmologicals |
2023-09 |
Celltrion HealthCare Co Ltd |
Biosimilar Part of 'aligned review' with a health technology assessment organization |
Aflibercept |
Ophthalmologicals |
2023-10 |
Amgen Canada Inc |
Biosimilar Part of 'aligned review' with a health technology assessment organization |
Aflibercept |
Ophthalmologicals |
2024-02 |
Apotex 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 |
Amphetamine aspartate monohydrate, amphetamine sulfate, dextroamphetamine sulfate, mixed salts amphetamine |
Psychoanaleptics |
2024-04 |
KYE Pharmaceuticals Inc |
Not applicable |
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 |
Artesunate |
Antiprotozoals |
2024-09 |
Amivas Ireland Ltd. |
New active substance Being reviewed under the Priority Review Policy |
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 |
Beclomethasone dipropionate, formoterol fumarate dihydrate, glycopyrronium bromide |
Drugs for obstructive airway diseases |
2023-05 |
Chiesi Farmaceutici S.P.A. |
Part of 'aligned review' with a health technology assessment organization |
Belantamab mafodotin |
Antineoplastic agents |
2024-09 |
GlaxoSmithKline Inc |
New active substance Part of 'aligned review' with a health technology assessment organization |
Belantamab mafodotin |
Antineoplastic agents |
2024-09 |
GlaxoSmithKline Inc |
Part of 'aligned review' with a health technology assessment organization |
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 |
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 |
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 |
Celecoxib |
Antiinflammatory and antirheumatic products |
2024-02 |
Scilex Pharmaceuticals Inc. |
Part of 'aligned review' with a health technology assessment organization |
Chloroprocaine hydrochloride |
Ophthalmologicals |
2025-02 |
Apotex Inc |
Part of 'aligned review' with a health technology assessment organization |
Cipaglucosidase alfa |
Other alimentary tract and metabolism products |
2024-06 |
Amicus Therapeutics Canada Inc. |
New active substance Part of 'aligned review' with a health technology assessment organization |
| Clobetasol propionate | Ophthalmologicals | 2025-03 | Apotex Inc | Part of 'aligned review' with a health technology assessment organization |
Crovalimab |
Immunosuppressants |
2024-05 |
Hoffmann-La Roche Limited |
New active substance 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 Healthcare Co Ltd |
Biosimilar |
Denosumab |
Drugs for treatment of bone diseases |
2024-05 |
Celltrion Healthcare Co Ltd |
Biosimilar |
Denosumab |
Drugs for treatment of bone diseases |
2024-05 |
Samsung Bioepis Co., Ltd |
Biosimilar |
Denosumab |
Drugs for treatment of bone diseases |
2024-05 |
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 |
Deutivacaftor, tezacaftor, vanzacaftor calcium |
Other respiratory system products |
2024-09 |
Vertex Pharmaceuticals (Canada) Incorporated |
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 |
Elafibranor |
Bile and liver therapy |
2024-09 |
Ipsen Biopharmaceuticals 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 |
Elinzanetant |
Other gynecologicals |
2024-09 |
Bayer Inc |
New active substance |
Epinephrine |
Drugs for obstructive airway diseases |
2025-02 |
ARS Pharmaceuticals Operations, Inc. |
Part of 'aligned review' with a health technology assessment organization |
Garadacimab |
Antithrombotic agents |
2023-12 |
CSL Behring Canada Inc |
New active substance |
Glucagon |
Pancreatic hormones |
2024-11 |
Lupin Pharma Canada Limited |
Not applicable |
Imlunestrant tosylate |
Antineoplastic agents |
2025-02 |
Eli Lilly Canada Inc |
New active substance Part of an 'aligned review' with a health technology assessment organization |
Labetalol hydrochloride |
Beta blocking agents |
2023-11 |
Hikma Canada Limited |
Not applicable |
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 |
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 |
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 |
Methohexital sodium |
Anesthetics |
2024-09 |
Sterimax Inc |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
Midazolam hydrochloride |
Psycholeptics |
2024-06 |
Neuraxpharm Pharmaceuticals, S.L. |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
Miglustat |
Other alimentary tract and metabolism products |
2024-06 |
Amicus Therapeutics Canada Inc. |
Part of 'aligned review' with a health technology assessment organization |
| 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 |
mRNA encoding haemagglutinin of B/Victoria lineage, haemagglutinin of influenza A/H1N1, haemagglutinin of influenza A/H3N2, SARS-CoV-2 spike protein NTD-RBD subdomains |
Vaccines |
2025-02 |
Moderna Biopharma Canada Corporation |
New active substance For use in relation to COVID-19 |
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 |
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 |
Oritavancin diphosphate |
Antibacterials for systemic use |
2024-08 |
Xediton Pharmaceuticals Inc |
New active substance Being reviewed under the Priority Review Policy |
Osilodrostat phosphate |
Corticosteroids for systemic use |
2023-02 |
Recordati Rare Diseases Canada Inc |
New active substance Part of 'aligned review' with a health technology assessment organization |
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 |
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 |
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 |
Quizartinib |
Antineoplastic agents |
2024-08 |
Daiichi Sankyo Pharma Canada Limited |
New active substance Part of 'aligned review' with a health technology assessment organization |
Repotrectinib |
Antineoplastic agents |
2024-05 |
Bristol-Myers Squibb Canada |
New active substance |
Rifapentine |
Antimycobacterials |
2025-03 |
Macleods Pharmaceuticals Limited |
New active substance |
Risperidone |
Psycholeptics |
2022-03 |
Teva Canada Limited |
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 |
Tapinarof |
Antipsoriatics |
2023-05 |
Dermavant Sciences GmbH |
New active substance |
Teplizumab |
Drugs used in diabetes |
2024-10 |
Sanofi-Aventis Canada Inc |
New active substance Being reviewed under the Priority Review Policy |
Teprotumumab |
Immunosuppressants |
2024-05 |
Amgen Canada Inc |
New active substance Part of 'aligned review' with a health technology assessment organization |
Terbinafine hydrochloride |
Antifungals for dermatological use |
2024-01 |
Medexus Pharmaceuticals Inc. |
Part of 'aligned review' with a health technology assessment organization |
Testosterone undecanoate |
Sex hormones and modulators of the genital system |
2024-12 |
Marius Pharmaceuticals |
Not applicable |
Testosterone undecanoate |
Sex hormones and modulators of the genital system |
2025-01 |
Tolmar International Ltd. |
Not applicable |
Tirzepatide |
Drugs used in diabetes |
2024-07 |
Eli Lilly Canada Inc |
Not applicable |
Tislelizumab |
Antineoplastic agents |
2025-02 |
Beigene Switzerland GmbH |
New active substance Part of 'aligned review' with a health technology assessment organization |
Tocilizumab |
Immunosuppressants |
2024-07 |
Celltrion Inc |
Biosimilar |
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 |
Triamcinolone acetonide |
Corticosteroids, dermatological preparations |
2024-03 |
Bausch & Lomb Inc |
Not applicable |
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 |
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 |
Zuranolone |
Psychoanaleptics |
2024-12 |
Biogen Canada Inc |
New active substance |
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