Biosimilars Initiative

The New Brunswick Department of Health launched a Biosimilars Initiative in 2021 which involves switching patients from originator biologic drugs to their biosimilar versions. It is a result of an evidence-informed strategy to better optimize our public resources, get the best value for new treatments and services, and improve access to medications for patients.

Biologics represent some of the largest drug expenditures for the New Brunswick Drug Plans. Increasing the use of biosimilars provides savings that will be used to cover new drugs and contribute to the sustainability of the public drug plans.

Patients who use certain originator biologics must switch to a biosimilar brand to maintain their coverage under the New Brunswick Drug Plans. The drugs included in the Biosimilars Initiative and the date by which patients must switch to a biosimilar brand are in the table below. Additional originator biologics will be added when their biosimilar brands are listed as benefits.

Current Switch Period(s)
None

Completed Switches to Biosimilars
 

Biologics are drugs that are made from living cells through a complex manufacturing process. The first version of a biologic drug is called an originator biologic drug but may also be called an innovator or reference biologic.

A biosimilar drug, or biosimilar, is a biologic drug that is very similar to but less expensive than its originator biologic drug. There are no expected differences in efficacy and safety between a biosimilar and the originator biologic drug.

Due to the complexity of the manufacturing process, no two batches of biologics are identical. This means there are differences between different batches of the originator biologics, as well as between originator biologics and biosimilars. These variations do not affect the drug’s effectiveness.

Approval of biosimilars

• Health Canada reviews and approves all drugs before they can be sold in Canada.
• When the patent for an originator biologic expires, other manufacturers may produce biosimilars.
• Biosimilar drugs undergo a rigorous review process and must demonstrate they have no clinically meaningful difference compared to the originator biologic drug.

Switching to a biosimilar

• There are more than 100 research studies on biosimilars in rheumatology, gastroenterology, dermatology and other diseases, which collectively show little to no clinical differences between biosimilars and their biologic originators, either when used with treatment-naïve patients, or for patients switching to a biosimilar.
• These studies did not show any significant differences in safety, efficacy or immunogenicity after switching compared to patients who were not switched.
• The majority of switching studies also found that efficacy loss associated with switching to biosimilars was the same as is expected for patients who remain on the originator drug.