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.

Submissions currently under review: New drug submissions
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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