The GI Society (Canadian Society of Intestinal Research) recently published an updated list of originator biologicals and biosimilars used to treat inflammatory bowel disease (IBD), specifically Crohn’s disease and ulcerative colitis, in Canada.
Biological treatments have become crucial for managing Crohn’s disease (CD) and ulcerative colitis (UC), especially for patients who do not respond well to conventional therapies. These therapies target specific components of the immune system to reduce inflammation and prevent further tissue damage, providing a lifeline for many IBD patients.
Currently, seven biological molecules marketed under 23 brand names, are approved in Canada for Crohn’s disease and ulcerative colitis. Among these, three have biosimilar versions available: adalimumab (8 biosimilars), infliximab (5), and ustekinumab (2), representing 15 brands [1]. Table 1 details the indications for these molecules and their available delivery methods (infusion or injection).
| Table 1: Biological therapies currently available for Crohn’s disease and ulcerative colitis in Canada
|
| Molecule
|
Brand Name
|
Adult
|
Paediatric
|
Infusion
|
Injection
|
|
|
|
CD
|
UC
|
CD
|
UC
|
|
|
| adalimumab originator
|
Humira (AbbVie)
|
✓
|
✓
|
✓1
|
✓4
|
|
✓
|
| adalimumab biosimilar
|
Abrilada (Pfizer)
|
✓
|
✓
|
✓1
|
✓4
|
|
✓
|
| Amgevita (Amgen)
|
✓
|
✓
|
✓1
|
✓4
|
|
✓
|
| Hadlima (Organon)
|
✓
|
✓
|
|
|
|
✓
|
| Hulio (Viatris)
|
✓
|
✓
|
✓1
|
✓4
|
|
✓
|
| Hyrimoz (Sandoz)
|
✓
|
✓
|
✓1
|
✓4
|
|
✓
|
| Idacio (Fresenius Kabi)
|
✓
|
✓
|
✓1
|
|
|
✓
|
| Simlandi (JAMP Pharma)
|
✓
|
✓
|
|
|
|
✓
|
| Yuflyma (Celltrion)
|
✓
|
✓
|
|
|
|
✓
|
| infliximab originator
|
Remicade (Janssen) Omvyence (Janssen)§
|
✓
|
✓
|
✓2
|
✓3
|
✓
|
|
| infliximab biosimilar
|
Avsola (Amgen)
|
✓
|
✓
|
✓2
|
✓3
|
✓
|
|
| Inflectra (Pfizer)
|
✓
|
✓
|
✓2
|
✓3
|
✓
|
|
| Ixifi (Pfizer)
|
✓
|
✓
|
✓3
|
✓3
|
✓
|
|
| Remsima (Celltrion)
|
✓
|
✓
|
|
|
|
✓
|
| Renflexis (Organon)
|
✓
|
✓
|
✓2
|
✓3
|
✓
|
|
| golimumab originator
|
Simponi (Janssen)
|
|
✓
|
|
|
|
✓
|
| mirikizumab originator
|
Omvoh (Eli Lilly)
|
|
✓
|
|
|
✓
|
✓
|
| risankizumab originator
|
Skyrizi (AbbVie)
|
✓
|
|
|
|
✓
|
✓
|
| ustekinumab originator
|
Stelara (Janssen)
|
✓
|
✓
|
|
|
✓
|
✓
|
| ustekinumab biosimilar
|
Steqeyma (Celltrion)
|
✓
|
|
|
|
✓
|
✓
|
| Wezlan (Amgen)
|
✓
|
✓
|
|
|
✓
|
✓
|
| vedolizumab originator
|
Entyvio (Takeda)
|
✓
|
✓
|
|
|
✓
|
✓
|
|
1. Indicated for children 13 to 17 years old, weighing more than 40 kg (88 lbs), with severe disease and have failed conventional and/or some biologics.
2. Not for use for children less than 9 years of age.
3. Not for use for children less than 6 years of age.
4. Indicated for children 5 years of age and older, with moderate to severe disease and have failed conventional therapies (e.g., corticosteroids and immunosuppressants). §Omvyence (infliximab, Janssen Inc) was approved on 29 December 2020, by Health Canada. This product is not biosimilar. CD: Crohn’s disease; UC: ulcerative colitis.
|
To improve patient convenience, some biosimilars offer innovative injection devices beyond the standard pre-filled syringe and pen. For example, Amgen’s adalimumab is available with the SureClick autoinjector, and Organon provides the PushTouch autoinjector, enhancing ease of use for patients managing IBD.
A third Ustekinumab, Jamteki, is also approved in Canada; however, it is only approved for the indications of psoriasis and psoriatic arthritis.
As of October 2024, Health Canada has approved 61 biosimilars [2], with 15 specifically indicated for Crohn’s disease and ulcerative colitis, as shown in Table 1. This diverse array of biological and biosimilar options allows patients to personalize their treatment, accommodating both age-specific needs and personal preferences for either infusion or injection.
With an expanding variety of biological and biosimilar options, Canadian patients with IBD have more choices than ever. Collaborating closely with healthcare providers to select the most suitable treatment—considering both clinical efficacy and convenience—enables patients to better manage their condition and improve their quality of life. As treatment options continue to grow, patients can look forward to more tailored and effective care for managing IBD.
Related articles
Canada's path to biosimilar adoption and healthcare accessibility: insights from British Columbia
Three more biosimilar approvals in Canada in 2023
|
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References
1. GaBI Online - Generics and Biosimilars Initiative. Canada approves trastuzumab Adheroza and ustekinumab Steqeyma biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 26]. Available from: www.gabionline.net/biosimilars/news/canada-approves-trastuzumab-adheroza-and-ustekinumab-steqeyma-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Update of biosimilars approved by Health Canada in 2023 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 26]. Available from: www.gabionline.net/biosimilars/news/update-of-biosimilars-approved-by-health-canada-in-2023
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada
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