Biosimilars FAQ for Patients

Biologic drugs are made using living organisms (e.g. yeast or animal cells) instead of chemical substances. They can be used to treat patients with certain serious chronic conditions.

When patents on an original biologic (originator) drug expire, other manufacturers may use a similar process to produce drugs called biosimilars. Due to their complex structure, biosimilars are not identical, but they are highly similar to the originator.

Because biologic drugs are manufactured using living organisms with some inherent variability, there are very small differences between each batch. These differences are natural and not clinically meaningful. Every biosimilar batch is tested to ensure safety and efficacy.

Since they are so complex, biologic drugs are expensive and time-consuming to develop. In B.C., biologic drugs that PharmaCare switched to biosimilar versions – Enbrel®, Remicade®, and Lantus® and now Humira® – represent some of the province’s (and Canada’s) largest drug expenditures.

Biosimilars are made based on an existing version of a biologic drug (called an “originator” biologic), and so require far less research and development. They are less expensive to produce, don’t compromise efficacy and safety, and offer major cost savings that can be reinvested into our health care system.

Health Canada is responsible for ensuring the safety, efficacy, and quality of all new drugs in Canada, including biosimilars. For a biosimilar drug to be approved for use, Health Canada must find no meaningful differences in safety and effectiveness compared to the originator. The biosimilars covered by PharmaCare have been approved by Health Canada and are already in widespread use.

If you are covered by PharmaCare and you currently take Humira® or Enbrel® for any conditions including those listed in the table below, you must switch to an approved biosimilar version of your medication before the end of the switch period to maintain your coverage.

Switch Period: April 7, 2021 to October 6, 2021

Drug

Originator

Biosimilar

Conditions Include

adalimumab

Humira®

Amgevita®

Hadlima®*

Hulio®

Hyrimoz®*

Idacio®

 

ankylosing spondylitis

Crohn’s disease

hidradenitis suppurativa (for adults)

plaque psoriasis (for adults)

polyarticular juvenile idiopathic arthritis

psoriatic arthritis

rheumatoid arthritis

ulcerative colitis

etanercept

Enbrel®

Brenzys®

Erelzi®

plaque psoriasis (for adults)

*Hadlima and Hyrimoz are not yet approved to treat pediatric Crohn's disease

Talk to your prescriber about your biosimilar options.

Though a biosimilar is not identical to an originator drug, there are no meaningful differences between them. The same safety, efficacy, and health outcomes is evidenced by a large body of clinical studies. Health Canada expects no clinical differences between a biosimilar and its originator and assures patient and health professionals that biosimilars are safe and effective for their approved indications.

Ask your prescriber about your biosimilar options.

A patient’s mindset can influence their symptoms and sense of well-being. The nocebo effect is when negative expectations of a treatment lead to negative outcomes. It can arise from mental health issues, language barriers, online media as an information source, interactions with healthcare professionals, the setting in which the patient receives information, and other factors outside the control of healthcare professionals.

To combat a potential nocebo effect, you can:

  • Acknowledge the nocebo effect
  • Seek out more information on biosimilars (see Resources for Patients)
  • Speak to your pharmacist or doctor about the switch and your biosimilar options
  • Keep a neutral or positive outlook

Some patients cannot switch to a biosimilar for medical reasons. Your prescriber can help you determine if it is medically necessary for you to remain on the originator medication. If it is, they can submit a Special Authority request asking PharmaCare to consider continued coverage of the originator. Exceptional requests are considered on a case-by-case basis.

Many European nations have required patients taking originator biologics, under publicly funded coverage plans, to switch to biosimilars. These patients have been tracked in many studies. The clinical trials and registry data findings are regularly reported at the European League Against Rheumatism (EULAR) and American College of Rheumatology (ACR) annual scientific meetings. More than 75 research studies in rheumatology, gastroenterology, dermatology and other diseases collectively show no meaningful clinical differences for the majority of patients after a switch from an originator to its biosimilar.

These studies also found that any decreased effectiveness, from switching to biosimilars, was the same as expected for patients who remained on the originator.

The Ministry of Health will be carefully monitoring drug usage, patient outcomes, and feedback from patients and healthcare practitioners both during and after the Biosimilars Initiative.

Biosimilar manufacturers provide patient support programs, as well as access to infusion centres similar to those for originator drugs. Your prescriber can help you enroll in a patient support program, if applicable.

Adalimumab

Amgevita®

The Enliven® patient support program is for patients prescribed AMGEVITA®. The program gives patients access to services such as reimbursement navigation, financial assistance, adherence assistance, injection training and nurse support. Enliven® can also help patients with Crohn's disease and ulcerative colitis access laboratory testing.

Contact the Enliven patient support program at:

Phone

1-877-936-2735

Fax

1-833-423-0252

Email

AMGEVITA@oneenliven.ca

Hours

Monday to Friday, 8:00 am to 8:00 pm EST

Hadlima®

The Merck Harmony® patient support program is for patients prescribed Hadlima®. The program gives patients access to services such as cost reimbursement navigation, financial assistance, self-injection training and coordination of laboratory testing.

To enroll, both the prescriber and patient must sign a completed Merck Harmony® support group enrolment form.

Contact the Merck Harmony® patient support program at:

Phone

1-866-556-5663

Fax

1-866-240-4076

Email

info@merckharmony.ca

Hours

Monday to Friday, 8:00 am to 8:00 pm EST

Hulio®

The Viatris advocate program is for individuals prescribed a Viatris immunology product. The program gives patients access to services such as cost reimbursement assistance, nurses for adherence support, and therapy administration assistance.

Contact the Viatris advocate program at:

Phone

1-844-485-4677

Fax

1-844-554-8546

Email

hulio@assistprogram.com

Hours

Monday to Friday, 8:00 am to 8:00 pm EST

Hyrimoz®

The XPOSE® by Sandoz patient support program is for patients prescribed HYRIMOZ® . The program gives patients access to services such as a nurse case manager, cost reimbursement assistance, injection services, clinical support services such as TB testing, fecal calprotectin, and therapeutic drug monitoring.

Contact the XPOSE® by Sandoz patient support program at:

Phone

1-888-449-7673

Fax

1-844-449-7673

Email

xpose@sandozprogramsupport.ca

Hours

Monday to Friday, 9:00 am to 9:00 pm Pacific time

Idacio®

The KabiCare program by Fresenius Kabi supports patients prescribed Idacio® (adalimumab injection) and their health care team. KabiCare gives patients access to services such as reimbursement navigation, financial assistance, and patient education.

Contact KabiCare at:

Phone

1-888-304-2034

Fax

1-888-304-2014

Email

info@kabicare.ca

Hours

Monday to Friday, 9:00 am to 5:00 pm Pacific time

Etanercept

Brenzys®

The Merck Harmony® Patient Support Program provides support services, including coordination with private payers for patients taking Brenzys®. To enroll a patient, contact the Merck Harmony® central number, and you will be directed to an assigned coordinator.

Phone 1-866-556-5663
Fax 1-866-240-4076
Email

info@merckharmony.ca

Hours Monday to Friday, 8:00 am to 8:00 pm EST

Erelzi®

The Erelzi XPOSE® program provides support services, including self-injection training, for patients taking Erelzi®. Both the prescriber and patient must complete and sign an enrolment form to enroll in the program.

Phone 1-844-279-7673
Fax 1-866-872-5771
Hours Monday to Friday, 5:00 am to 5:00 pm Pacific time

Please talk to your insurer. PharmaCare does not maintain information on private insurance policies for biologics or any other prescription medications.

For more information, see Biosimilars Initiative for Patients.

If you have further questions or concerns, contact PharmaCare by:

Phone: 1-844-915-5005 (Monday to Friday, 8:30 am to 4:30 pm Pacific time)
Email: Biosimilars.Initiative@gov.bc.ca