Biosimilars

Overview

Starting on March 31, 2023, Ontario Drug Benefit (ODB) recipients who are on an originator biologic will begin to transition to a Health Canada approved biosimilar version of the drug.

A transition period will occur between March 31, 2023 and December 29, 2023 to allow ODB program recipients to switch from an originator biologic to a biosimilar version in order to maintain ODB program coverage for their biologic. ODB program recipients will be required to switch to a biosimilar version before December 29, 2023 to maintain ODB program coverage for their biologic, unless an exception applies.

Biosimilar drugs

Biosimilar drugs are proven to be as safe and effective as the alternative higher priced originator biologic drugs and are able to treat many of the same conditions. Numerous studies show little to no difference in safety and efficacy when patients move to a biosimilar. Biosimilars have been used in the European Union for more than 15 years and Ontario is following a number of Canadian jurisdictions, including British Columbia, Alberta, New Brunswick, Quebec, Northwest Territories, Nova Scotia and Saskatchewan, to expand the use of biosimilar medications.

Biologic medicines have improved the treatment of many disabling and life-threatening diseases. Patients will continue receiving the same high-quality treatment, while allowing the government to fund more new drug therapies, bring innovation to the health care system and continue its work to deliver better, connected patient care. 

Affected drugs

You may need to switch to the biosimilar drug to get coverage through the ODB program if you are taking:

• Copaxone®^{footnote 1[1]}
• Enbrel®
• Humalog®
• Humira®
• Lantus®
• NovoRapid®
• Remicade®
• Rituxan® 

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. 

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.

As new biosimilars are approved by Health Canada, and enter the Canadian market, additional biologic drugs may be included as part of this policy change.

Ask your specialist, doctor, nurse practitioner or pharmacist for more information about how the change will affect you.

ODB Program coverage

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 and 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, that company has the sole right to make and sell the drug for awhile. After that period ends, other companies can start making their own version. The biologic drug that other companies make is the biosimilar drug.

Health Canada does a lot of testing and has clearly said that biosimilars are just as safe and effective as the originator biologic drugs.

An originator biologic is the first version of a biologic drug. Originator biologic drugs include:

• Lantus®
• Enbrel®
• Remicade®
• Rituxan®
• Humalog®
• Humira®
• NovoRapid® 

Once an originator biologic’s market exclusivity ends, other manufacturers can start producing highly similar versions of originator biologics, called “biosimilar” drugs that work in the same way. These biosimilars do not have the same costs to bring the product to market and can be offered at a much lower cost.

This change will also impact you if you are taking Copaxone® (glatiramer), which is a non-biologic complex drug (NBCD). Copaxone® and Glatect® are both glatiramer acetate products manufactured and marketed by different companies. Glatiramer acetate is classified as a non-biologic complex drug (NBCD). Such as the case for biosimilars, Glatect® is a highly similar and more affordable version of the brand medication Copaxone®. Health Canada has conducted rigorous testing to ensure Glatect® is safe and effective.

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. The Ontario government is confident in the safety and efficacy of biosimilars based on our experience over the past 10 years, as well as the experiences of many countries around the world.

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.

Process for switching

If you are using a biologic that is included in the policy:

• 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 on the policy change 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 Remicade® or Rituxan®, as part of the biosimilar transition, you may have to go to a new infusion centre to receive your infliximab or rituximab infusion.

The Ministry of Health has been working closely with our 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:

• phone: 1-855-935-FLEX (3539)  (toll-free)
• fax: 1-833-958-3539
• abrilada.ca

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.

• phone: 1-877-936-2735 (toll-free)
• fax: 1-833-423-0252
• email:
  • amgevita@oneenliven.ca (for Amgevita®)
  • avsola@oneenliven.ca (for Avsola®)
  • info@oneenliven.ca (for general inquiries)
• amgevita.ca
• avsola.ca

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: 

• phone: 1-866-556-5663
• fax: 1-866-240-4076
• email: info@harmonybyorganon.ca

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

Erelzi®

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

• A 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
• a seamless enrollment process flexible to Health Care Provider’s preference
• provincially expert 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 XPOSE® Patient Support Program either through our toll-free number or email address and speak with your Case Worker and/or Field Case Manager.

• phone: 1-888-449-7673 (toll-free)
• fax: 1-844-449-7673
• email: xpose@sandozprogramsupport.ca

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:

• phone: 1-833-ALL-Y100 (255-9100) (1-833-255-9100) (toll-free)
• fax: 1-833-255-9544
• email: ally@patientassistance.ca
• glatect.com/en/all-about-the-ally-program/

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:

• phone: 1-844-485-4677 (toll-free)
• fax: 1-844-554-8546
• email: hulio@assistprogram.com
• hulio.ca

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

Hyrimoz®

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

• a 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
• a seamless enrollment process flexible to health care provider’s preference
• provincially expert 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 XPOSE® by Sandoz Patient Support Program and speak with your Patient Care Specialist and/or Nurse Case Manager by:

• phone: 1-888-449-7673 (toll-free)
• fax: 1-844-449-7673
• email: xpose@sandozprogramsupport.ca

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:

• phone: 1-888-304-2034 (toll-free)
• fax: 1-888-304-2014
• email: info@kabicare.ca
• kabicare.ca

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:

• phone: 1-855-935-3539 (toll-free)
• fax: 1-833-958-3539
• email: inflectra@pfizerflex.com
• pfizerflex.ca

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

Riximyo®

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

• a 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 infusion services
• a seamless enrollment process flexible to health care provider’s preference
• provincially expert 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 XPOSE® by Sandoz Patient Support Program and speak with your Patient Care Specialist and/or Nurse Case Manager by:

• phone: 1-888-449-7673 (toll-free)
• fax: 1-844-449-7673
• email: xpose@sandozprogramsupport.ca

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:

• phone: 1-855-935-3539 (toll-free)
• fax: 1-833-958-3539
• email: ruxience@pfizerflex.com
• pfizerflex.ca

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:

• phone: 1-800-575-1379 (toll-free)
• email: customerservice.ca@viatris.com
• semglee.ca 
• kirsty.ca

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:

• phone: 1-855-310-5102 (toll-free)
• fax: 1-888-331-3432
• email: jampcare@supportprogram.com
• jampcare-support.ca/en/simland.html

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:

• phone: 1-877-714-2469 (toll-free)
• fax: 1-833-981-2254
• email: tss.info@truximacanada.com
• tevacanada.com/en/canada/our-products/specialty-medicines/patient-support/

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:

• phone: 1-855-966-1648 (toll-free)
• fax: 1-855-966-2223
• email: support@celltrionconnect.ca
• celltrionconnect.ca/en/yuflyma/

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

Resources

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

• Arthritis Society Canada - Biologics and Biosimilars for the Treatment of Inflammatory Arthritis
• Health Canada - Biosimilar biologic drugs in Canada: Fact Sheet
• CADTH: Biosimilar Drugs: Your Questions Answered (cadth.ca)
• Arthritis Consumer Experts Biosim Exchange
• Arthritis Consumer Experts: Biosimilars in Canada - What inflammatory arthritis patients need to know
• Canadian Digestive Health Foundation: Infographic on What’s Health Canada Saying about Biosimilars
• Canadian Digestive Health Foundation: What’s Health Canada Saying about Biosimilars? (Youtube)
• Canadian Arthritis Patient Alliance (CAPA) - Questions you may wish to ask your healthcare provider about biosimilars
• Canadian Arthritis Patient Alliance (CAPA) - Better understanding biosimilar medications (YouTube)
• Canadian Arthritis Patient Alliance (CAPA) - What is a biosimilar? (YouTube)

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:

• email: DrugProgramsDelivery@ontario.ca 
• phone: 416-327-8109 or 1-866-811-9893 and pressing “1” for the Public Inquiries Officer