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Biosimilars 101

Over the past 50 years biologic medicines have revolutionized the treatment and prevention of many disabling and life-threatening diseases. But biologic medicines are also expensive, and many can cost $10,000 to $25,000 or more per year to treat a single patient. Public and employee-sponsored benefit plans want to expand their coverage of patients to include more innovative new medicines, but they also need to manage costs.

Fortunately, there is an important solution to this challenge. Patents on many originator biologic drugs have expired, and other manufacturers are now able to produce subsequent entry medicines called biosimilar biologic drugs. Biosimilars have been a standard fixture in patient care in Europe for more than 15 years. The use of biosimilars in Canada continues to grow, with more than 2.1 million retail prescriptions for biosimilars medicines filled annually and the increasing use of biosimilars in hospitals for oncology and other treatments.

What is an originator biologic drug?

Biologic drugs come from living organisms or from their cells. They are often made using biotechnology. Examples of biologic drugs include insulin, growth hormones and antibodies. Biologic drugs are used to treat diseases and medical conditions including anemia, cancer, diabetes, eye disorders and diseases, inflammatory bowel disease, psoriasis, rheumatoid arthritis and venous thromboembolism. Biologic drugs are generally larger and more complex in composition than chemically produced pharmaceutical drugs.

An originator biologic drug is the first version of a biologic drug approved for an active substance. It is protected by patents and other forms of intellectual property protection and enjoys a market monopoly for many years before it can be used as a reference biologic drug by Health Canada for the approval of a subsequent entry biologic, known as a biosimilar biologic drug.

What is a biosimilar biologic drug?

A biosimilar biologic drug, or biosimilar, is a drug demonstrated to be highly similar to a biologic drug that was already authorized for sale. Health Canada evaluates all the information provided to confirm that the biosimilar and the reference biologic drug are similar and that there are no clinically meaningful differences in safety and efficacy between them. Health Canada’s rigorous standards for authorization mean that you can have the same confidence in the quality, safety and efficacy of a biosimilar as any other biologic drug.

Learn more about biosimilars

Biosimilars Canada and its partners with the International Generic and Biosimilar Medicines Association (IGBA) have developed the following educational materials to help the public and other stakeholders learn more about the history, science, benefits and real-world experience with biosimilar biologic drugs. We invite you to explore the six modules below.