A biologic is a drug that is made from living cells. Vaccines, insulin, and monoclonal antibodies are examples of biologics. They have large, complex molecular structures. Some of the biologic medications are engineered to target specific activity in the immune system to treat inflammation. Inflammation is the body’s normal response to things like injury, infection (e.g., bacteria, viruses), stress, and pain. For reasons not yet understood, sometimes the immune system does not function properly and causes damage to healthy tissue. Biologics stop or reduce inflammation by blocking key cells or chemicals involved in triggering inflammation. In IBD patients, use of biologics blocks inflammation in the gut and allows it to heal. 

Biologics are generally administered under the skin by injection or intravenously by infusion. There are different types of biologics used to treat Crohn’s disease and ulcerative colitis:

Anti-TNF Biologics

One of the signals involved in causing inflammation in people with Crohn’s or colitis is called tumour necrosis factor alpha, or TNF-alpha. Biologic medications that block those signals are known as anti-TNF biologics.

α4β7 Integrin Blockers Biologics or selective adhesion molecule inhibitors (SAM)

These biologic medications block the attachment of white blood cells to tissues, preventing them from entering the lining of the gut and causing inflammation. 

Antibody to the p40 subunit of IL-12 and IL-23

IL-12 and IL-23 are messenger chemicals that recruit white blood cells into the gut to cause inflammation. Anti-p40 medications block the messenger signal of both IL-12 and IL-23 to reduce inflammation. 

In Canada, biologics can also be used as treatment for many other complex conditions, including arthritis, cancer, osteoporosis, psoriasis, HIV, multiple sclerosis, and more. If you have moderate to severe inflammatory bowel disease (IBD), you should discuss with your physician if biologic therapy is appropriate for you.


With the use of biotechnology, specific cells isolated from living organisms are given a piece of DNA (gene) that codes for a specific protein. These cells will produce this specific protein in large amounts that can then be harvested for use as biologics in patients. 

Biologics tend to be higher in costs than simple small molecule drugs due to their complex manufacturing, transport, and administration. Manufacturers of biologics tend to offer a wide variety of support to patients, including coordination of injection/infusion services and assistance with reimbursement. Private insurers and public health programs can provide partial or complete financial coverage for biologics, depending on specific eligibility criteria. 


All medications are associated with risk and benefits. Risks of using biologics may include injection or infusion site reactions, allergic reactions, and infection. Your doctor will work with you to determine proper dosage to help balance your symptoms and potential side effects.


As with other medicines, once a patent expires for a biologic, it is legal for other manufacturers to reproduce the drug. Most medicines, such as aspirin, are small molecule products, which mean they have simple molecular structures that are easy to reproduce or copy. Such copies are called generic drugs. By comparison, biologics are very large and have complex molecular structures. It is impossible to produce an exact copy without using the exact same ingredients, the living cell lines, and manufacturing conditions. Therefore, the drug that is produced by another manufacturer can never be considered identical to the initial biologic and is referred to as a ‘biosimilar’ (and not a ‘generic’). 

Read our factsheet for more information about biosimilars in Canada.


Because biosimilars are not identical to originator biologics, Health Canada regulates biosimilars as new drugs and states clearly that biosimilars are not generic biologics. Health Canada only approves biosimilars for marketing in Canada when the manufacturer demonstrates that their product is of highly similar quality, safety, and efficacy (effectiveness) to their reference biologic drug. Health Canada requires that there be no clinically meaningful differences in safety and efficacy. Currently, there are two IBD biosimilars approved by Health Canada, but additional biosimilars are expected in the near future, as the patents for innovator biologics continue to expire.  

See below for a full list of biotherapies currently available in Canada. 


Drug Name: Adalimumab

Biologic Name (Indications*): Humira®
  • Moderate to severe Crohn’s disease (adult and pediatric), and ulcerative colitis (adult).
  • Used for patients who have not responded well to conventional therapies, or who have lost response to other biologics.
  • Method of Administration: SC*
Biosimilar Name (Indications*): N/A

Drug Name: Infliximab

Biologic Name (Indications*): Remicade​®
  • Moderate to severe Crohn’s disease (adult and pediatric), and fistulizing Crohn’s (adult and pediatric).
  • Moderate to severe ulcerative colitis (adult and pediatric).
  • Patients who have not responded well to conventional therapies.
Biosimilar Name (Indications*): Inflectra​®
  • Moderate to severe Crohn’s disease (adult), and fistulizing Crohn’s.
  • Moderate to severe ulcerative colitis (adult).
  • Method of Administration: IV*
Biosimilar Name (Indications*): Renflexis®
  • Moderate to severe Crohn’s disease (adult and pediatric), and fistulizing Crohn’s.
  • Moderate to severe ulcerative colitis (adult and pediatric).
  • Method of Administration: IV*

Drug Name: Golimumab 

Biologic Name (Indications*): Simponi®
  • Moderate to severe colitis (adults).
  • Used when conventional medicines have not worked or cannot be tolerated, or in patients who have demonstrated steroid dependence.
  • Method of Administration: SC*
Biosimilar Name (Indications*): N/A

α4 β7 Integrin Blockers

Drug Name: Vedolizumab

Biologic Name (Indications*): Entyvio​®
  • Moderate to severe Crohn’s disease and colitis (adults).
  • Used when conventional medicines have not worked well or cannot be tolerated, and in patients who have not had satisfactory response with infliximab.
  • Method of Administration: IV*
Biosimilar Name (Indications*): N/A

Antibody to the p40 subunit of IL-12 and IL-23

Drug Name: Ustekinumab

Biologic Name Treatment (Indications*): Stelara®
  • Moderate to severe Crohn’s disease (adults).
  • Used when conventional therapies have not worked or cannot be tolerated, or in patients who have failed or were intolerant to treatment with one or more TNF blockers.
  • Method of Administration: First dose by IV. Subsequent doses by SC.*
Biosimilar Name Treatment (Indications*): N/A


  • Indications may vary between originator and biosimilar drug. Product monographs provide detailed descriptions of indications for each drug listed in the table.
  • Subcutaneous injection (SC): A short needle is inserted into the layer of tissue between the skin and the muscle.
  • Intravenous injection (IV): A needle or tube is used to insert the drug directly into a vein.

Need more information?

Click on the drug name below to download a PDF of the product monograph: Humira, Remicade, InflectraRenflexisSimponiEntyvioStelara

A comparison chart PDF of the above Biologics and Biosimilars is also available for download Here.


Typically, if a patient has a prescription for a small molecule medication, a pharmacist is authorized to substitute a generic version without consulting with the patient’s physician. This is called interchangeability. The provincial health ministries decide whether to require interchangeability in their respective provinces. 

Some provincial governments are implementing or considering implementing interchangeable policies with biologics. It is the position of Crohn’s and Colitis Canada that decisions about switching from a biologic to a biosimilar should be made by the physician and patient in consultation. Learn more about our legal/ethics review, evidence review, and position statement.

We think that treatment decisions should be made between you and your doctor. Policy change made at the expense of your health is not okay. If you agree, take part in our letter-writing campaign to let your local government representative know how you feel!


Individuals doing well on a biologic innovator drug should be aware of the risks and benefits of substituting the innovator drug with its biosimilar. Because biologics are ‘foreign’ proteins that were not produced by the patient’s own genes, the body can develop antibodies to the biologic over time. This immune response is called immunogenicity. Once antibodies to a biologic are formed by a patient’s body, the biologic may stop working or cause an allergic-like reaction. Whether immunogenicity is made more likely by switching among biologics and biosimilars remains unclear. Some researchers believe that there is sufficient clinical evidence to suggest that switching does not increase or accelerate immunogenicity while others believe that more rigorous clinical studies are required. 

LEARN MORE ABOUT BIOTHERAPIES for crohn's and colitis

Read our factsheet for more information about biosimilars and non-medical switch in Canada

Click on the video below to learn from experts in the field about biologic and biosimilar treatment options which have recently been made available.

To learn more about biologic and biosimilar medications for Crohn's and colitis, download or order a copy of our brochure

Click here for an information sheet about biologic and biosimilar medications, developed by the Gastrointestinal Society of Canada in collaboration with Crohn’s and Colitis Canada.

  • Canada has among the highest incidence rates of Crohn's and colitis in the world.
  • 1 in 140 Canadians lives with Crohn’s or colitis.
  • Families new to Canada are developing these diseases for the first time.
  • Incidence of Crohn’s in Canadian kids under 10 has doubled since 1995.
  • People are most commonly diagnosed before age 30.

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