Sixty per cent of all prescriptions in Canada are paid for by employer-provided drug plans and some have life-time limits for biologic reimbursement. However, transitioning to a biosimilar could extend this limit for patients, said Dr. John Esdaile, scientific director at Arthritis Research Canada, during Benefits Canada’s Halifax Benefits Summit on Sept. 24.

Biologic drugs are derived through the metabolic activity of living organisms and tend to be more variable and more structurally complex than chemically synthesized drugs, he said, noting many measures are taken to assess the structure and utility of a biosimilar in comparison to its biologic.

“Biosimilars have an identical amino acid sequence [to their biologic] and must be very similar on multiple functional and structural analyses. Natural variability is inherent to all biological medicines and strict controls are always in place during manufacturing to ensure it doesn’t affect the way the medicine works or its safety. The variability in batches of biologic molecules is as large as the difference between a biologic and a biosimilar. Thus, each batch of a biologic is, in fact, a biosimilar itself.”

Read: Biosimilars have potential to offer relief for rising drug plan costs

For a decade, biosimilars have been approved for use in Europe, said Dr. Esdaile, with those for arthritis in use since 2003. Between 2006 and 2017, EU regulators approved 28 biosimilars and another seven are currently under review, he added. And, according to the Canadian Agency for Drugs and Technologies in Health, Europeans will have saved somewhere in the range of 20 billion euros by 2020 through the use of biosimilars.

The European Medicines Agency has published a guide for health-care practitioners with information on the science and regulation underpinning the use of biosimilars. The agency hasn’t identified any relevant difference in the nature, severity or frequency of adverse effects between 28 biosimilars and their reference medicines, noted Dr. Esdaile.

Further, the majority of countries in the EU — including Belgium, France, Denmark, Germany, the Netherlands, Norway, Portugal and the U.K. — support physician-led transitioning for biosimilars, he said. As of March 2017, an agreement across these countries has stated that biologics shouldn’t be substituted at the pharmacy level without the involvement of the clinical decision-maker.

Read: Rising biosimilar uptake touted amid ‘continuously evolving’ evidence for safety, efficacy

On the other hand, in the U.S., the Federal Drug Agency approved its first biosimilar in 2015. Since then, it’s approved 16 with 60 more under review. As for Health Canada, 14 biosimilars have been approved to date and another 15 are under review. However, Health Canada recommends that a decision to switch a patient being treated with an originator biologic drug to a biosimilar, or between any biologics, be made by the treating physician in consultation with the patient and take into account any policies of the relevant jurisdiction.

“The leading regulators in the world, including our own, are in agreement about the safety and efficacy of biosimilars — short and long term. These regulatory bodies support well-controlled transition. However, in Canada, prior to transition, a discussion between a health-care provider and their patient is recommended.”

Read more stories from the 2019 Halifax Benefits Summit.

Copyright © 2020 Transcontinental Media G.P. Originally published on

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