In the last days of 2022, the Government of Ontario decided to put its weight behind the use of biosimilars.
Starting March 31st, 2023, Ontario Drug Benefit recipients who are using an originator biologic will be transferred to a biosimilar at no cost. Drugs like Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® are to be phased out, with patients required to transition by the end of 2023. Minister of Health Sylvia Jones says patients will continue to receive the same quality treatment, while allowing the government to fund more new drug therapies and deliver better healthcare overall.
Biologic medicines are complex molecules made with living organisms like yeast or animal cells. Some drugs like aspirin have simple molecules, making copies or generic versions easy to manufacture. Biologics, on the other hand, are sprawling molecular compounds created by living cells using specialized ingredients and a specific manufacturing process.
Biologics are often used to treat skin diseases like psoriasis, and bowel diseases like irritable bowel syndrome and Crohn’s disease. They can also be used to treat arthritis and kidney conditions. In cancer care, biologics are used to kill cancer cells, treat the side effects patients experience due to other cancer symptoms, and boost the patient’s immune system.
Because of its complexity, it is impossible to replicate a biologic medicine. However, once the patent expires for the biologic, other manufacturers can create biosimilars. But because the biologic is so complex, the biosimilar will not be exactly the same.
For the patient, this is normally not an issue. As long as patient outcomes and potential side effects are the same, biosimilars can be used in place of biologics. According to organizations like Cancer Care Ontario, there is no clinically meaningful differences between the two. The main benefit of biosimilars is that they are cheaper for the patient and, ultimately, the government.
However, organizations like the Canadian Association of Gastroenterology recommend using the biologic medicine over the biosimilar if the cost is comparable. This is because the biologic is the original and has been initially approved by Health Canada (biosimilars are approved by Health Canada as well, although the process is not as complex as the approval of biologics). If the original biologic is working and there is no real cost savings to be had, why complicate care by making the switch?
While biologics and biosimilars are considered to be interchangeable, the decision to change the medication should lie in the hands of the physician. After all, they are the one who knows the specifics of a patient’s cancer care, as each case is unique. However, in several provinces, soon to include Ontario, the switch isn’t being mandated by a doctor, but by the government.
Luckily for those in Ontario, the government has said that exceptions will be considered on a case-by-case basis. During the transition period, patients are encouraged to discuss their plan with their healthcare provider. Patients should have a thorough talk with their cancer care team about what it means for them if they switch to the biosimilar of the biologic medicine they are using, including a discussion about side effects, what to look for if you have an adverse reaction, and how this will impact your care.
While biosimilars can be used in place of biologics, the devil is in the details, and in cancer care, details are important. As the government mandates the transition this year, make sure you advocate for your rights as a patient to ensure you are receiving the correct treatment for your specific cancer.