Overview

On March 31, 2023, Ontario Drug Benefit (ODB) recipients who were on select originator biologics began to transition to a Health Canada approved biosimilar version of the drug within defined transition periods.

Going forward, as additional biologic drugs are added to the ministry’s biosimilar transition policy framework, a transition period will be provided. This will allow the patient to transition to the biosimilar version of the drug and expect the same treatment outcome.

Affected drugs

If you are taking one of the originator biologics listed in the table below, you will need to switch to a biosimilar version within the listed transition period to receive coverage for the biologic through the ODB program, unless an exception applies to you.

Transition PeriodOriginator (Drug)
March 31, 2023, to December 28, 2023
  • Copaxone® (glatiramer) footnote 1
  • Enbrel® (etanercept)
  • Humalog® (insulin lispro)
  • Humira® (adalimumab)
  • Lantus® (insulin glargine)
  • NovoRapid® (insulin aspart)
  • Remicade® (infliximab)
  • Rituxan® (rituximab)
July 31, 2024, to January 31, 2025
  • Lovenox® (enoxaparin)
  • Lucentis® (ranibizumab)
  • Neupogen® (filgrastim)
  • Stelara® (ustekinumab)

Drugs not listed

If you are taking another ODB program covered biologic not listed above, it will still be covered. As new biosimilars are approved by Health Canada and enter the Canadian market, additional biologic drugs may be subject to this transition requirement. This webpage will be updated to reflect the applicable biologic drug and transition period.

Your specialist, doctor or nurse practitioner will need to provide you with a new prescription for the biosimilar version of the drug that you will be using. Ask your specialist, doctor, nurse practitioner or pharmacist for more information about how the change will affect you.

Exceptions

If you are or become pregnant during a specified transition period or require palliative care during a specified transition period, then you may be eligible to continue receiving ODB program coverage for the originator biologic for a limited period of time if you meet certain criteria.

This exception may not apply if the biologic is not indicated for use in palliative care and/or pregnant patients. Please consult your pharmacist or prescriber for more information.

Additionally, if you have a medical reason why you can’t switch to the biosimilar, your specialist, doctor or nurse practitioner may request an exemption for you that will be considered on a case-by-case basis through the Exceptional Access Program.

Exemptions will be considered for patients in certain clinical circumstances, such as if you have experienced a negative reaction to at least two biosimilars.

ODB Program coverage

Drug

Originator biologic

(Recipients must transition to the biosimilar version before December 29, 2023)

Biosimilars funded under ODB Program effective March 31, 2023

Indications

(Transition for other indications funded on a case-by-case basis which may not appear on the below list also applies)

AdalimumabHumira®
  • Abrilada®
  • Amgevita®
  • Hadlima®
  • Hulio®
  • Hyrimoz®
  • Idacio®
  • Simlandi®
  • Yuflyma®

 

  • Ankylosing spondylitis
  • Crohn’s disease
  • Hidradenitis suppurativa
  • Plaque psoriasis
  • Polyarticular juvenile idiopathic arthritis
  • Psoriatic arthritis
  • Rheumatoid arthritis
  • Ulcerative colitis
  • Uveitis
EnoxaparinLovenox®
  • Elonox®
  • Inclunox®
  • Noromby®
  • Redesca®
  • Prevention and treatment of deep venous thrombosis
  • Treatment of pulmonary embolism
EtanerceptEnbrel®
  • Brenzys®
  • Erelzi®
  • Ankylosing spondylitis
  • Plaque psoriasis
  • Polyarticular juvenile idiopathic arthritis
  • Psoriatic arthritis
  • Rheumatoid arthritis
FilgrastimNeupogen®
  • Grastofil®
  • Nivestym®
  • Nypozi®
  • Prevention and treatment of neutropenia
Glatiramer acetateCopaxone®
  • Glatect®
  • Relapsing Remitting Multiple Sclerosis (RRMS)
InfliximabRemicade®
  • Avsola®
  • Inflectra®
  • Renflexis®
  • Ankylosing spondylitis
  • Crohn’s disease
  • Plaque psoriasis
  • Psoriatic arthritis
  • Rheumatoid arthritis
  • Ulcerative colitis
Insulin aspartNovoRapid®
  • Kirsty®
  • Trurapi®
  • Diabetes (Type 1 and 2)
Insulin glargineLantus®
  • Basaglar®
  • Semglee®
  • Diabetes (Type 1 and 2)
Insulin lisproHumalog®footnote 2
  • Admelog®
  • Diabetes (Type 1 and 2)
RanibizumabLucentis®
  • Byooviz®
  • Ranopto®
  • Age-related macular degeneration (AMD)
  • Diabetic macular edema (DME)
  • Branch retinal vein occlusion (BRVO)
  • Central retinal vein occlusion (CRVO)
  • Chorodial neovascularization
RituximabRituxan®
  • Riabni®
  • Riximyo®
  • Ruxience®
  • Truxima™
  • Rheumatoid arthritis
  • Granulomatosis with Polyangiitis (GPA or Wegener’s Granulomatosis)
  • Microscopic Polyangiitis (MPA)
UstekinumabStelara®
  • Jamteki®
  • Wezlana®
  • Severe plaque psoriasis

Originator biologics versus biosimilars

Biologics are medicines made from substances found in living things. They are often used to treat diseases such as:

  • cancer
  • immune system disorders
  • diabetes

A biosimilar biologic drug is a highly similar but generally less expensive version of an originator biologic drug. When a company develops a new biologic drug (an originator), that company has the sole right to make and sell the drug for a certain period of time. After that period ends, other companies can start making their own version. The biologic drug that other companies make is the biosimilar drug.

Biosimilars are not identical to originator biologics. However, Health Canada conducts rigorous testing to ensure that biosimilars have a highly similar structure, are equally as safe, and have the same therapeutic effect as the originator biologic. Numerous studies show little to no difference in safety and efficacy when patients move to a biosimilar. Biosimilars have been used extensively in the European Union and all Canadian jurisdictions, with the exception of Manitoba, have implemented similar biosimilar policies to expand the funding of biosimilar medications.

Health Canada is responsible for ensuring the safety, efficacy, and quality of all drugs. For a biosimilar drug to be approved in Canada, Health Canada must find no meaningful differences in safety and effectiveness compared to the originator biologic. The biosimilars included in Ontario’s expanded biosimilars policy have all been approved by Health Canada and are already in widespread use.

Biologic medicines, including biosimilars, have improved the treatment of many disabling and life-threatening diseases. The transition to biosimilars will allow patients to continue receiving the same high-quality treatment, while allowing the government to:

  • fund more new drug therapies
  • encourage innovation in the health care system
  • continue to support the delivery of better, more connected patient care

Process for switching

If you are using a biologic that is subject to the transition requirement.

  • Make an appointment as soon as possible during the transition period, with your specialist, doctor or nurse practitioner. Your specialist, doctor or nurse practitioner is also receiving information about the transition requirement and may be reaching out to you.
  • Discuss transitioning to the biosimilar with your specialist, doctor, nurse practitioner or pharmacist. Note that only your specialist, doctor or nurse practitioner will be able to write a new prescription for you.
  • Your specialist, doctor or nurse practitioner will explain the transition process, discuss your options, write you a new prescription, and help enroll you in a patient support program, if applicable.

Infusion clinics

For ODB program recipients taking a biologic drug that is subject to the transition requirement at an infusion clinic, you may have to go to a new infusion centre to receive your infusion of the biosimilar drug.

The Ministry of Health has been working closely with its health care partners to ensure that ODB Program recipients who require an infusion have access to an infusion clinic that can deliver the biosimilar. Infusion clinics in Ontario are ready to support ODB program recipients with their transition to a biosimilar.

At home

For ODB program recipients who are self-administering their biologic product at home but who are affiliated with a patient support program, you may need to be enrolled in a new patient support program associated with the biosimilar you will be using.

Preventing the nocebo effect

The nocebo effect occurs when a patient’s negative expectations affect the treatment outcomes. A patient’s mindset can impact their perceived symptoms and their sense of well-being.

To combat against a potential nocebo effect, you can:

  • acknowledge the nocebo effect
  • inform yourself about biosimilars
  • discuss biosimilars with your specialist, doctor, nurse practitioner or pharmacist and what it means for you
  • keep a neutral or positive outlook
  • stay informed about the switch process

Patient support programs

Some biosimilar manufacturers provide patient support programs (PSP) and services, along with access to infusion centres, similar to those of the originator biologic drug. If applicable, specialists, doctors or nurse practitioners can help initiate the enrolment process into a PSP.

Abrilada®

Registering to the PfizerFlex Patient Support Program gives:

  • live support for questions about the program or treatment
  • reimbursement expertise
  • experienced team members to help you access your medication as quickly as possible
  • access to a reliable infusion/injection clinic network, staffed by qualified healthcare professionals
  • practical tools to help you navigate your treatment plan

Contact the PfizerFlex Patient Support Program by:

Hours of operation: Monday to Friday, 8 a.m. to 8 p.m.

Amgevita® and Avsola®

Amgen Biosimilar patients, living in Ontario, will receive the same level of support and services that Enbrel® patients have received through the Enliven program by Amgen Entrust Patient Support Services over the last 20+ years.

Hours of operation: Monday to Friday, 8 a.m. to 8 p.m.

Brenzys®, Renflexis® and Hadlima®

The HARMONY BY ORGANON™ Patient Support Program provides eligible patients access to:

  • a designated HARMONY BY ORGANON™ coordinator
  • comprehensive reimbursement support and assistance with special authorization (SA) forms
  • financial assistance, temporary bridging, and coverage of additional doses when applicable
  • monitoring and lab testing support
  • vaccination support
  • paid subscription to the LyfeMD app, a lifestyle intervention-based program that focuses on nutrition, yoga, breathing, mindfulness, and physical activity programs

Additional services for HADLIMA® and BRENZYS®:

  • coordination with patient’s preferred pharmacy
  • self-injection training options to help patients get started on treatment
  • on-going injection support
  • extended travel assistance program including a travel case and travel documentation

Additional services for RENFLEXIS®:

  • infusion appointment coordination
  • network of approximately 600 clinics across Canada

HARMONY BY ORGANON™ has a Patient Support Team and services to help create a personalized journey for those enrolled. We are an experienced partner that can help you support your patients through customized enrollment options and transition plans.

To enroll a patient in the HARMONY BY ORGANON™ Patient Support Program, please contact the Program by: 

Hours of operation: Monday to Friday 8 a.m. to 8 p.m. EST

Erelzi®

The SANDOZ PLUS Patient Support Program provides services that are designed to help patients get quickly started with ERELZI® and support them throughout their treatment.

  • dedicated support team that is available to assist patients and Health Care Providers with reimbursement, paperwork, prescription renewal reminders, record keeping of patient documents and injection training services
  • seamless enrollment process flexible to Health Care Provider’s preference
  • expert provincial reimbursement navigation and adapted financial assistance
  • injection services with tailored options for patient convenience
  • continually updated clinical support services for patients
  • services and support adapted to each patient category and age group
  • health management support and education for physicians, nurses and pharmacists
  • specific services to assist community pharmacists supporting patients on biosimilars

To enroll a patient or have any of your questions answered, please contact the SANDOZ PLUS Patient Support Program either through our toll-free number or email address and speak with your Case Worker and/or Field Case Manager.

Hours of operation: Monday to Friday, 8 a.m. to 8 p.m.

Glatect®

The Ally Patient Support Program has been designed to provide Canadian Multiple Sclerosis RRMS patients and their healthcare professionals, efficient, value-added service aimed at insuring rapid treatment onset and sustained medication compliance on GLATECT. The Ally Patient Support Program consists of:

  • patient enrolment
  • initial welcome call
  • provision of no cost goods support program
  • compliance and adherence monitoring through patient follow up calls by ALLY Program representatives to ensure patient program satisfaction and medication compliance
  • patient self-injection training upon the first injection by a nurse or web-based questions (telephonic or by field registered nurses) and subsequent trainings as needed available upon request
  • reimbursement navigation
  • financial support
  • reporting of adverse events, product complaints, medical information requests and other reportable safety information
  • specialty pharmacy set up

Contact the program by:

Hours of Operation: Monday to Friday, 8 a.m. to 8 p.m.

Hulio®

The Viatris Advocate™ patient support program offers patients prescribed Hulio®:

  • a dedicated case manager
  • pre-requisites diagnostic testing support
  • injection training
  • reimbursement navigation and financial assistance as needed
  • flexible medication delivery services
  • treatment adherence reminder calls

Contact the program by:

Hours of operation: Monday to Friday, 8 a.m. to 8 p.m. EST

Hyrimoz®

The SANDOZ PLUS Patient Support Program provides services that are designed to help patients get quickly started with HYRIMOZ® and support them throughout their treatment through:

  • dedicated support team that is available to assist patients and Health Care Providers with reimbursement, paperwork, prescription renewal reminders, record keeping of patient documents and injection training services
  • seamless enrollment process flexible to Health Care Provider’s preference
  • expert provincial reimbursement navigation and adapted financial assistance
  • injection services with tailored options for patient convenience
  • continually updated clinical support services, including tuberculosis (TB) testing, fecal calprotectin, Therapeutic Drug Monitoring (TDM)
  • services and support adapted to each patient category and age group
  • health management support and education for physicians, nurses and pharmacists
  • specific services to assist community pharmacists supporting patients on biosimilars

To enroll a patient or have any of your questions answered, please contact the SANDOZ PLUS Patient Support Program and speak with your Patient Care Specialist and/or Nurse Case Manager by:

Hours of operation: Monday to Friday, 8 a.m. to 8 p.m.

Idacio®

KabiCare is a responsive program, tailored to patients and health care providers offering high patient satisfaction through:

  • single point of contact case managers
  • reimbursement navigation
  • financial assistance
  • patient education nursing support as well as other services.

Contact the program by:

Hours of operation: Monday to Friday 9 a.m. to 5 p.m.

Inflectra®

Registering to the PfizerFlex Patient Support Program gives:

  • live support for questions about the program or treatment
  • reimbursement expertise
  • experienced team members to help you access your medication as quickly as possible
  • access to a reliable infusion/injection clinic network, staffed by qualified healthcare professionals
  • practical tools to help you navigate your treatment plan.

Contact the program by:

Hours of operation: Monday to Friday, 8 a.m. to 8 p.m.

Riximyo®

The SANDOZ PLUS Patient Support Program provides services that are designed to help patients get started quickly with RIXIMYO® and support them throughout their treatment through:

  • dedicated support team that is available to assist patients and Health Care Providers with reimbursement, paperwork, prescription renewal reminders, record keeping of patient documents and injection training services
  • seamless enrollment process flexible to Health Care Provider’s preference
  • expert provincial reimbursement navigation and adapted financial assistance
  • a broad and open patient-centric network of infusion clinics
  • continually updated clinical support services for patients
  • health management support and education for physicians, nurses and pharmacists
  • specific services to assist community pharmacists supporting patients on biosimilars

To enroll a patient or have any of your questions answered, please contact the SANDOZ PLUS Patient Support Program and speak with your Patient Care Specialist and/or Nurse Case Manager by:

Hours of operation: Monday to Friday, 8 a.m. to 8 p.m.

Ruxience®

Registering to the PfizerFlex Patient Support Program gives:

  • live support for questions about the program or treatment
  • reimbursement expertise
  • experienced team members to help you access your medication as quickly as possible
  • access to a reliable infusion/injection clinic network, staffed by qualified healthcare professionals
  • practical tools to help you navigate your treatment plan

Contact the program by:

Hours of operation: Monday to Friday, 8 a.m. to 8 p.m.

Semglee® and Kirsty®

The Viatris Advocate™ program is a financial support program for individuals prescribed a Viatris insulin biosimilar which includes a bridging program and a copay of up to 25%* of the cost of the prescription.

*Based on reasonable upcharge, mark-up, and customary pharmacy fee.

Unique certification number: 00001001VI 
Group: 37437 
For more information, contact Viatris customer service by:

Hours of operation: Monday to Friday, 8:30 a.m. to 4:30 p.m. EST

Simlandi®

JAMP Care provides a comprehensive package of services including:

  • dedicated local Nurse Field Case Managers, a single point of contact for enrollment support, injection training and help throughout the patient’s journey
  • laboratory and vaccination services, including:
    • routine blood work
    • tuberculosis (TB) skin test
    • Quantiferon Gold (GRA) TB test
    • Therapeutic Drug Monitorin (TDM)
    • fecal calprotectin
    • QuantON cal testing
    • Shingrix
    • more (like COVID-19)
  • flexible and easy enrollment process
  • fast reimbursement navigation support
  • bridging (as needed)
  • financial assistance (including Quebec)
  • Auxita: The online and electronic medical record patient support platform
  • patient mobile first web app for faster service and communications
  • clinical testing and vaccinations
  • for patients:
    • medication delivery
    • educational materials
    • injection training at-home or in-clinic
    • welcome packages
    • print and online value-added tools
  • Nurse Field Case Manager patient adherence and follow-ups with clinic
  • pharmacy program trained support available as needed
  • nutrition counselling available on demand

Contact the program by:

Hours of operation: Monday to Friday, 8 a.m. to 8 p.m.

Truxima®

Truxima® Teva Support Solutions® (Truxima® TSS) is a comprehensive program that provides personalized support to patients with rheumatoid arthritis, granulomatosis with polyangiitis (GPA, also known as Wegener's Granulomatosis) and microscopic polyangiitis (MPA) who have been prescribed Truxima®.

Through this simple and effective program, patients can speak directly with an expert case manager for advice and answers to a vast array of questions on related topics, such as product information, symptom management, instructions for the first infusion appointment, and treatment coverage.

Truxima® Teva Support Solutions® (Truxima® TSS) offers the following services to patients currently on Truxima®:

  • unique point of contact
  • reimbursement navigation
  • financial assistance
  • site-of-care coordination
  • infusion appointment scheduling

Contact the program by:

Hours of operation: Monday to Friday, 8 a.m. to 8 p.m.

Yuflyma®

Celltrion Healthcare Canada offers CELLTRION CONNECT™, a patient-focused support program tailored to support patients and healthcare providers. The program provides:

  • guidance with reimbursement navigation
  • financial assistance
  • injection and nurse support services
  • pharmacy support services for patients throughout treatment

Contact the program by:

Hours of operation: Monday to Friday, 8 a.m. to 8 p.m.

Resources

For more information and reading materials, see the resources below.

Contact

For any questions about how this policy applies to you, please contact your specialist, doctor, nurse practitioner or pharmacist.

For more information about the biosimilar policy, please contact the Ontario Public Drug Programs by: