Toronto – March 27, 2023 – Biosimilars Canada, a national association representing Canada’s biosimilar medicines industry, welcomes the announcement by the Government of Newfoundland and Labrador that it is implementing a “switching” or transitioning policy to expand the use of biosimilar biologic medicines for its public drug program.
Residents of the province who are enrolled in the Newfoundland and Labrador Public Drug Program (NLPDP) and take certain biologic medicines will need to transition to a biosimilar biologic medicine on or before March 31, 2024 in order to maintain coverage. This will enable the NLPDP to invest in new and innovative drug therapies while continuing to expand access to existing drug treatments.
“Biosimilars Canada and its member companies congratulate Health and Community Services Minister Tom Osborne and the Government of Newfoundland and Labrador for implementing a biosimilars switching policy to help support the long-term sustainability of the province’s public drug program,” said Jim Keon, President of Biosimilars Canada.
The Province of Newfoundland and Labrador is the ninth jurisdiction in Canada to announce a biosimilars switching policy, and follows British Columbia (May 2019), Alberta (December 2019), New Brunswick (April 2021), Quebec (July 2021), the Northwest Territories (December 2021), Nova Scotia (February 2022), Saskatchewan (October 2022) and Ontario (December 2022).
Switching from an originator biologic drug to a biosimilar is a safe and effective practice. Health Canada confirms that “patients and health care providers can have confidence that biosimilars are effective and safe for each of their authorized indications, and that no differences are expected in efficacy and safety following a change in routine use between a biosimilar and its reference biologic drug in an authorized indication.” 1
Biologic medicines have revolutionized the treatment of many disabling and life-threatening diseases. They can, however, cost $10,000 to $25,000 or more to treat a patient for a year, which is placing an enormous financial strain on drug budgets.
The full benefits of biosimilars cannot be realized unless drug plans adopt policies that support their expanded use with the implementation of successful biosimilar transitioning or “switching” policy. Under these policies patients who use a biologic drug to treat a chronic condition are transitioned or “switched” from an original biologic drug to a biosimilar biologic drug under the supervision of their treating physician.
There is extensive real-world experience with biosimilars in Canada, with more than 1.77 million retail prescriptions filled annually, according to market data from IQVIA. Biosimilars are also used extensively in the hospital and oncology markets. There have also been more than 178 clinical trials worldwide involving approximately 21,000 switched patients, which confirm that switching from an originator biologic drug to a biosimilar biologic drug is not associated with any major efficacy, safety, or immunogenicity issues. 2
About Biosimilars Canada
Biosimilars Canada is a national association representing the biosimilar medicines industry in Canada. Our member companies are at the forefront of the global development and marketing of biosimilar medicines. Biosimilars Canada provides leadership in educating Canadian stakeholders about the safety and efficacy of biosimilar medicines, and advocates for policies that support their timely approval, reimbursement, market acceptance and expanded use. Biosimilars Canada is a division of the Canadian Generic Pharmaceutical Association. Visit us at www.biosimilarscanada.ca.
About Biosimilar Medicines 3
A biosimilar biologic drug, or biosimilar, is a drug demonstrated to be highly similar to a biologic drug that was already authorized for sale. Health Canada evaluates all the information provided to confirm that the biosimilar and the reference biologic drug are similar and that there are no clinically meaningful differences in safety and efficacy between them. Health Canada’s rigorous standards for authorization mean that you can have the same confidence in the quality, safety and efficacy of a biosimilar as any other biologic drug.
Contact:
Jeff Connell
Vice President, Corporate Affairs
Canadian Generic Pharmaceutical Association (CGPA)
Mobile: (647) 274-3379 | Email: jeff@canadiangenerics.ca
[1] Health Canada, Biosimilar biologic drugs in Canada: Fact Sheet.
[2] Barbier, L. et. al. The Efficacy, Safety, and Immunogenicity of Switching Between Reference Biopharmaceuticals and Biosimilars: A Systematic Review, March 31, 2020.
[3] Health Canada, Biosimilar biologic drugs in Canada: Fact Sheet