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Understanding Biosimilars

What is a biosimilar?
A biosimilar product is a biologic product that is approved based on demonstrating that it is highly similar to an Health Canada‐approved biologic product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.[i]

Health Canada's rigorous standards for authorization mean that patients and health care providers can have the same confidence in the quality, safety and efficacy of a biosimilar as any other biologic drug.[ii]

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 reference biologic medicines, due to their complexity. Therefore, the processes used to develop generic medicines cannot be applied to the development of biosimilar medicines. [iii]

Can a patient already being treated with a reference biologic drug be switched to a biosimilar?
Health Canada considers a well-controlled switch from a reference biologic drug to a biosimilar in an approved indication to be acceptable, and recommends that a decision to switch a patient being treated with a reference biologic drug to a biosimilar, or between any biologics, be made by the treating physician in consultation with the patient and take into account available clinical evidence and any policies of the relevant jurisdiction.[iv]

Pfizer is aligned with Health Canada’s position on well-controlled switching between reference biologic drugs and biosimilars.

What does a “well-controlled switch” mean? What does it involve?
A well-controlled switch refers to switching patients who are currently on a reference biologic drug and respond well or are stable, to a biosimilar. Pfizer Canada believes that there are several important elements that should be included in a well-controlled switch policy:

  • The policymaker should ensure patients and physicians provide input into the policy.
  • Ample time should be provided to stakeholders to understand and support the policy’s implementation.
  • A physician and patient conversation should be part of the switch process. No switch should occur without patient awareness (a switch policy is not the same as interchangeability or automatic substitution).
  • An exemption process exists where physicians can provide medical justification for the patient to be excluded from switch policy and continue treatment on the reference biologic drug.
  • Patients should be monitored as per routine care for patients on biologics.
  • The economic savings realized from switching 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 biosimilars 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 will play a key role in creating a more sustainable health care system. 

 

 

[i] https://www.pfizerbiosimilars.com/characteristics-of-biosimilars  Accessed on May 2, 2019