Over 2 years after a cabinet vote to establish a biosimilar switching policy, the Ontario government is putting one in place, making it the seventh province and eighth jurisdiction in Canada to do so.
Ontario, Canada’s public health plan announced that it will finally establish a biosimilar switching policy. The measure comes after the province’s cabinet voted to implement a measure in 2020.
The province joins sixth others (Saskatchewan, British Columbia, Quebec, Alberta, New Brunswick, Nova Scotia) and 1 jurisdiction (Northwest Territories). Saskatchewan announced its biosimilar switching policy in October 2022.
The Ontario Drug Benefit (ODB) is the largest drug plan in Canada, accounting for about 40% of public drug spending in the country. Ontario is the province that is home to the nation’s capital (Ottowa) and its most populated city (Toronto). The measure also comes after Biosimilars Canada, a national association representing the biosimilar industry in Canada, held a press conference to pressure Premier Doug Ford’s administration to implement a biosimilar switching policy in October 2022.
Sylvia Jones, Ontario’s Health Minister, confirmed that the transition to biosimilars will enable Ontario to invest more money in new drug treatments and continue to grow its roster of publicly funded medications.
“Biosimilars Canada and its member companies congratulate Minister Jones and the Government of Ontario for moving ahead with a biosimilars switching policy, and remain committed to working with the government, specialists, and other stakeholders to ensure the smooth transition to biosimilars for Ontarians,” commented Jim Keon, president of Biosimilars Canada, in a statement praising the decision.
Under the program, patients who are either beginning or currently taking certain reference biologics will be switched to a biosimilar instead. For now, the program will primarily focus on reference biologics to treat chronic conditions, such as arthritis, diabetes, inflammatory bowel disease, and psoriasis. The transition period will begin March 31, 2023, and end December 29, 2023, during which providers will inform, educate, and facilitate their patients on medication changes.
Patients who are being administered Copaxone, Enbrel (etanercept), Humalog (insulin lispro), Humira (adalimumab), Lantus (insulin glargine), NovoRapid (insulin aspart), Remicade (infliximab), and Rituxan (rituximab) will be required to transition to a biosimilar or pay out-of-pocket for the reference product.
The Ontario government said that exemptions to the program will be considered for patients in “certain clinical circumstances on a case-by-case basis in consultation with their health care provider.”
Kelsey Cheyne, executive director, Canadian Digestive Health Foundation (CDHF), commented in Ontario’s statement saying, “Both biologics and biosimilars have gone through rigorous standards for authorization by Health Canada, to which both have been found safe and effective for use in [IBD]. CDHF knows having to change any kind of medication can be very stressful. While we believe in patient-physician choice, we acknowledge political policy decisions and our organization is committed to providing clear and unbiased information on biosimilars.”
Cheryl Koehn, founder and president of the Arthritis Consumer Experts, continued, saying that she hopes that the success from other Canadian provinces will make patients feel confident about the safety of switching to biosimilars and the government’s commitment to reinvesting the savings into the health care system, especially at a time when resourced to maintain and improve patient care are urgently needed.
Senators Introduce Bipartisan Legislation to Protect Skinny Labeling
January 2nd 2025To close out the year, 4 senators came together to introduce a new bipartisan bill to protect biosimilar and generic drug manufacturers from patent litigation when obtaining “skinny label” approvals for their products.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
The Top 5 Most-Read Policy Articles of 2024
December 28th 2024The top biosimilar policy articles of 2024 highlight advancements that include FDA guidance to simplify biosimilar interchangeability and CMS drug price negotiations under the Inflation Reduction Act, alongside challenges posed by pharmacy benefit manager rebate practices and the need for more active stakeholder engagement.
Top 5 Most-Read Regulatory Articles of 2024
December 25th 2024In 2024, significant biosimilar approvals were granted by the American and European regulatory agencies, including the first interchangeability designations for biosimilars referencing ustekinumab, adalimumab, denosumab, and aflibercept, marking key regulatory milestones in improving patient access to cost-effective treatments.
Empowering Vulnerable Populations: The Path to Equitable Biologic Therapy Access
December 22nd 2024Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, discusses strategies to improve equitable access to biologic therapies, including tiered formularies, income-based cost sharing, patient assistance programs, and fostering payer partnerships.