NLPDP Biosimilar Initiative

Biosimilars Initiative Overview

In March 2023, the Newfoundland and Labrador Prescription Drug Program (NLPDP) launched the NLPDP Biosimilars Initiative.  Under this initiative, NLPDP beneficiaries using certain originator biologics are transitioned to a safe and effective biosimilar version, in order to maintain drug plan coverage.  The NLPDP Biosimilars Initiative provides an evidence based opportunity to get the best value from medications funded under the program, without negatively affecting patient health outcomes.

Biologic drugs, commonly referred to as “Biologics”, are made using living organisms or their cells. An originator biologic drug is the first brand that is marketed. Biosimilars, are highly similar versions of the originator biologic that are marketed when the patent expires on the originator.  Due to natural variations in the manufacturing process related to the use of living cells, biosimilars are highly similar but not identical to the originator. In fact, due to this manufacturing process, small variations also occur when comparing batches of the originator drug.

Health Canada has developed a robust, science-based regulatory framework for the authorization of biosimilars.  This framework requires a biosimilar manufacturer to submit substantial evidence to demonstrate that the biosimilar is safe, effective and expected to produce the same clinical outcomes as the originator biologic.  There are many research studies which show little to no clinical differences between biosimilars and their originators, either when used with new patients, or for patients transitioning to a biosimilar. Tens of thousands of Canadians have successfully transitioned to biosimilars and thousands of NLPDP beneficiaries have been using biosimilars since 2016.

Biologic Medications Included in the NLPDP Biosimilars Initiative:

Drugs included in the NLPDP Biosimilars Initiative are identified in the table below.  When more than one biosimilar option exists for an originator, it is the patient’s choice, in consultation with their health professional, which biosimilar option they will use.   Additional originator biologics will be added to the initiative as new biosimilar options are approved by Health Canada and listed as benefits of NLPDP.

 

Biologic* Originator Biologic* Funded Biosimilar(s)* Originator coverage end date

Non-insulin Biologics
adalimumab Humira Abrilada, Amgevita, Hadlima, Hulio, Hyrimoz, Idacio, Simlandi, Yuflyma April 1, 2024
enoxaparin Lovenox Inclunox, Noromby, Redesca, Elonox April 1, 2024
etanercept Enbrel Brenzys, Erelzi April 1, 2024
glatiramer Copaxone Glatect April 1, 2024
infliximab Remicade Avsola, Inflectra, Renflexis April 1, 2024
rituximab Rituxan Riximyo, Ruxience, Truxima April 1, 2024
ranibizumab Lucentis Byooviz December 1, 2024

Insulin Biologics
Insulin aspart NovoRapid Kirsty, Trurapi April 1, 2024
Insulin glargine Lantus Basaglar, Semglee April 1, 2024
Insulin lispro Humalog Admelog April 1, 2024

*As the first biosimilar(s) come to market for an originator biologic after the launch of this initiative, a 12-month transition period will apply.  At the end of the 12-month transition period, funding and/or special authorizations for the originator biologic will end.

Contact Information

To learn more about the NLPDP Biosimilars Initiative, please visit our website or contact a representative at the Pharmaceutical Services Division:

  • Phone: (709) 729-6507 or toll free 1-888-222-0533
  • Fax: (709) 729-2851
  • Website: gov.nl.ca/hcs/prescription/biosimilars/
  • Mail:

Pharmaceutical Services Division
Department of Health and Community Services
P.O. Box 8700, Confederation Building
St. John’s, NL
A1B 4J6