• Biosimilars are highly similar copies of a biologic drug that is already approved by Health Canada. The already approved biologic drug is called the reference biologic because it is the drug that the biosimilar is compared to.
• Because of how complex they are, reference biologics and biosimilars cannot be identical, as opposed to generic drugs, but they are almost the same. A biosimilar and its reference biologic work in the same way and have the same safety and effectiveness.
• Based on Health Canada's guidelines and approval standards for the pharmacokinetics, pharmacodynamics, safety and clinical efficacy of biologics, there are no clinically meaningful differences between biosimilars and their reference biologics.
  

• Yes. For Health Canada to approve a biosimilar, the drug manufacturer must demonstrate through clinical trials that the biosimilar and the reference biologic are highly similar, and that there are no clinically meaningful differences in terms of safety and efficacy.
• Biosimilars are regulated as new drugs under the Food and Drugs Act and the Food and Drug Regulations. Health Canada's rigorous standards for authorization mean that patients and health care providers can rely upon the quality, safety, and efficacy of a biosimilar, just as for any biologic.
  

• Biosimilars save money for our cancer system and give us options during drug shortages. We can provide the same quality of care to our patients for less cost and the money saved can be reinvested into our health care system.
• Reference biologic drugs are protected by a patent. While reference biologic drugs are patent protected, only one company can sell that biologic, which makes them very expensive. As the patents for reference biologic drugs expire, other companies can request approval from Health Canada to sell biosimilars. Biosimilars are sold at a lower price, so the health care system saves money.  

As more biosimilars are approved, your patients may transition to a biosimilar. If your patients are transitioned, you will be notified ahead of time to start a discussion with your patient. ‎

Yes. Although Health Canada does not make any safety recommendations for off-label use of approved medications, Health Canada states that a biosimilar can have an indication different from what was studied for its approval based on scientific rationale. In Canada, some medications are occasionally used in cancers for which there is no Health Canada approval (e.g., bevacizumab in cervical cancer). In other regions (e.g., Europe), all indications for the reference biologic are extrapolated to the biosimilar.‎

Europe has used biosimilars for more than 10 years and has not found any concerns that the products are less safe or effective than their reference biologics.

Transitioning to Biosimilars Fact Sheet for Patients (BC Cancer)

Biosimilar Biologic Drugs (Health Canada)

Oncology Biosimilars Utilization Policy (III – 190)

Biologic drugs (biologics) are complex protein molecules created inside a living cell. Biologics have become mainstays in the treatment of many types of cancer, including breast, gastrointestinal, lung, lymphoma, ovarian and other cancers. Since biologics are made from living cells, every batch is almost the same but not identical.

Biosimilars have been in use for more than 10 years in Europe. As of January 2019, Europe had approved almost 60 different biosimilars. Europe has had more than 700 million patient treatment days with biosimilars, and has not detected any signals that the products were less safe or efficacious than their reference biologics. The National Health Service has achieved almost 100% uptake of rituximab biosimilar.