Biosimilars

What you Need to Know

What is a biosimilar?

  • Biologics are medicines taken by IV or self-injection and are made up of large protein molecules derived from living cells. There are now two versions of biologics: “originators” and “biosimilars.” These are near identical copies. The biosimilar has the identical amino acid sequence and is thus an identical twin of the originator. It is also roughly half the price of the originator.
  • A biosimilar has identical effectiveness, safety, immunogenicity profile and quality and delivers the same therapeutic benefits to patients as its biologic originator.
  • Biosimilars have been used for many years in chronic diseases such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, ulcerative colitis, Crohn’s Disease, cancer and biosimilars have been approved by Health Canada for use in Canada since 2009 and for use in inflammatory arthritis since 2014. Since the European Union approved the first biosimilar in 2006, the EU has approved more than 40 biosimilars.

How do patients know that biosimilar medications are safe and effective?

  • 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 medication.
  • The variation between biosimilars and originators is identical to the variation seen in different batches of the originator agent. That is, the next batch of an originator is akin to a biosimilar of itself.
  • There have also been more than 90 high-quality, mostly non-industry funded research studies comparing the efficacy and safety of biologic originators and biosimilars, and on the chances of biosimilars triggering immune responses.
  • Transition policy has been safely and effectively implemented with tens of thousands of patients with autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, gastrointestinal and bowel diseases in many countries in Europe. Registries of these patients on biosimilar therapies report on their continued safe and effective use at leading scientific meetings several times each year, and have done so over the past 5 years.

What does transitioning mean?

  • Transitioning refers to a one-time change from one medication to another, whether medically necessary or through a reimbursement policy change.
  • Health Canada considers well-controlled transitions from biologic originator to biologic biosimilar in an approved indication to be acceptable.
  • Health Canada recommends that a decision to transition a patient being treated with a biologic originator drug to a biosimilar, or between any biologics, be made by the treating physician in consultation with the patient, taking into account any policies of the relevant jurisdiction.
  • Prior to transitioning, both rheumatologists and their patients must be fully informed about the policy requiring the transition and have all available information about the biosimilar, such as details about the reimbursement policy, patient program information, including contact names and phone numbers.

Why are public and private payers considering implementing a biosimilars policy transitioning?

  • Provincial, territorial and private health insurers are under increasing pressure to deliver the latest treatments and care to a booming, aging population, most living with at least one, if not several, chronic diseases.
  • For tens of thousands living with autoimmune forms of chronic diseases such as inflammatory forms of arthritis, diabetes, gastrointestinal, bowel and other chronic diseases, a cornerstone of medication therapy is biologics.
  • For certain chronic disease patients, there is now at least one other company producing their biologic medication as the patent on their originator version has expired.
  • This biosimilar has the same therapeutic value as the originator, but costs less than the originators do currently.
  • The better cost-effectiveness of biosimilars will produce savings for public and private health insurers while having no deleterious effects on patient health and well-being.

The biosimilar is cheaper. Does that mean it’s not as good?

  • No. That is based on very detailed assessments by Health Canada, the European Medicine Agency and similar national government approval mechanisms around the world.
  • A biologic biosimilar enters the market after a biologic originator patent expires, just like a generic medication can do when the brand name medication’s patent expires.

What specific benefits do biologic biosimilars bring to patients and health care systems?

  • Biosimilars can create two substantial benefits to patients, the health care system, and society:
  1. Governments are reinvesting the savings generated from biosimilars in access to new medications that are not currently available, as well as considerably relaxing the rules for access to them. This will be a huge benefit to patients with inflammatory arthritis and psoriasis.
  2. Savings from biosimilars could be invested into non-medication types of care like specialized nursing, counselling, physio- and occupational therapy, and more. In some provinces there are discussions around a triage system to rapidly determine the best therapy track for new onset joint and spinal pain.

Which provinces have biosimilar transition policies?

Alberta

Alberta launched its Biosimilars Initiative in December 2019.

British Columbia

British Columbia launched its Biosimilars Initiative in May 2019.