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Understanding Biosimilars

What is a biosimilar?

A biosimilar biologic product is a biologic medicine authorized for sale based on demonstrating that it is highly similar to a biologic drug that was already authorized. Health Canada uses the same rigorous standards for quality, efficacy and safety when authorizing a biosimilar as any other biologic drug.1

How are biosimilars different from generic medicines?

While identical generic versions of small molecules can be chemically synthesized, it is not possible to create identical versions of originator biologic medicines, due to their complexity. Therefore, the processes used to develop generic medicines cannot be applied to the development of biosimilar biologic medicines.

Can a patient already being treated with an originator biologic drug be transitioned to a biosimilar biologic?

Health Canada states that biosimilars are authorized for the indications in the Product Monograph, and that “patients and health care providers can have confidence that biosimilars are effective and safe for each of their authorized indications. No differences are expected in efficacy and safety following a change in routine use between a biosimilar and its reference biologic drug in an authorized indication.2

Patients should also take into account available clinical evidence and any policies of the relevant jurisdiction.3 Many Canadian provinces have successfully implemented biosimilar transition policies.4

If you have any questions about changing from one biologic drug to another, you should speak to your health care practitioner.

What does a “well-controlled transition” look like for patients? What does it involve?

According to the Canadian Biosimilars Forum, a well-controlled transition involves a patient having a conversation with their physician about switching to a biosimilar.5 Pfizer Canada believes there are several important elements that should be included in a well-controlled transition for patients:

  • Active communication between patients and physicians to ensure patients are comfortable moving forward with the transition
  • Patients are enrolled in a Patient Support Program (PSP) which is offered by the biosimilar biologic manufacturer
  • Patients receive one on one personal communications with the Patient Support Program for their biosimilar to ask any questions or clarify any transition confusion or uncertainty
  • Patients should be monitored as per routine care for patients on originator biologics
  • PSP acts as a liaison between patient and physician and sends regular updates on how the transition is going and if the patient requires any further medical support/opinions
  • The economic savings realized from transitioning patients to biosimilars should be directed to funding new innovative therapies for patients.

Pfizer’s commitment to biosimilars

As part of its commitment to delivering the highest value of care to patients, Pfizer is applying its significant resources and proven ability to meet the world’s health care challenges to develop and deliver high-quality biosimilars. In fact, Pfizer has nearly a decade of experience bringing biosimilar biologics to patients around the world.

Pfizer has one of the most extensive biosimilars pipelines globally, with several molecules under development for the treatment of serious and chronic diseases.

We believe biosimilars play a key role in creating a more sustainable health care system.