Drug and Health Product Submissions Under Review (SUR): Supplemental submissions under review
This list is current as of: 2025-11-30.
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) |
|---|---|---|---|---|
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 |
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 |
Belimumab |
Immunosuppressants |
2023-11 |
GlaxoSmithKline Inc |
Not applicable |
Benralizumab |
Drugs for obstructive airway diseases |
2025-10 |
AstraZeneca Canada Inc |
Not applicable |
Bimekizumab |
Immunosuppressants |
2024-06 |
UCB Canada Inc |
Part of an 'aligned review' with a health technology assessment organization |
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 |
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 |
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 |
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 |
Finerenone |
Diuretics |
2025-03 |
Bayer Inc |
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 |
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 |
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 |
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 |
Lurbinectedin |
Antineoplastic agents |
2025-08 |
Jazz Pharmaceuticals Ireland Limited |
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 |
Nivolumab |
Antineoplastic agents |
2025-11 |
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 |
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 |
Pembrolizumab |
Antineoplastic agents |
2025-11 |
Merck Canada Inc |
Being reviewed under the Priority Review Policy |
Retifanlimab |
Antineoplastic agents |
2025-08 |
Incyte Corporation |
Not applicable |
Roflumilast |
Antipsoriatics |
2025-10 |
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 |
Selumetinib sulfate |
Antineoplastic agents |
2025-05 |
Alexion Pharma GmbH |
Not applicable |
Selumetinib sulfate |
Antineoplastic agents |
2025-09 |
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 |
Tapinarof |
Antipsoriatics |
2025-10 |
Organon Canada Inc. |
Not applicable |
Tarlatamab |
Antineoplastic agents |
2025-09 |
Amgen Canada Inc |
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 |
2025-08 |
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 |
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 |