PEI Biosimilar Initiative

Some drugs are made using living organisms or their cells. These drugs are called biologics. The first version of a biologic drug to be produced is called the originator or reference biologic.

Biosimilars are highly similar versions of originator biologic drugs. They are produced when the patent expires on the originator biologic drug. Biosimilars are less expensive drugs that are reviewed by Health Canada to ensure they work in the same way as the originator biologic drugs and are equally effective.

Through the PEI Biosimilar Initiative, coverage under PEI Pharmacare for certain biologic drugs will be replaced with coverage for biosimilar drugs. 

If you are covered for any of the following originator drugs through PEI Pharmacare, you will need to switch to a biosimilar version before the end of the switching period for that drug to keep your coverage.

Drug

Originator brand name (switch from)

Biosimilar brand name
(switch to)

Reimbursed conditions may include

End of switching period

Insulin aspart

NovoRapid®

Kirsty®
Trurapi®

Diabetes

June 30, 2024

Insulin glargine

Lantus®

Basaglar®
Semglee®

Diabetes

June 30, 2024

Insulin lispro

Humalog®

Admelog®

Diabetes

June 30, 2024

Adalimumab

Humira®

Abrilada®
Amgevita®
Hadlima®
Hulio®
Hyrimoz®
Idacio®
Simlandi™
Yuflyma™

Ankylosing spondylitis

Crohn's disease

Hidradenitis suppurativa

Juvenile idiopathic arthritis

Plaque psoriasis

Psoriatic arthritis

Rheumatoid arthritis

Ulcerative colitis

Uveitis

September 30, 2024

Etanercept

Enbrel®

Brenzys®
Erelzi®

Rymti®

Ankylosing spondylitis

Juvenile idiopathic arthritis

Plaque psoriasis

Psoriatic arthritis

Rheumatoid arthritis

September 30, 2024

Glatiramer acetate

(a non-biologic complex drug)

Copaxone®

Glatect™

Multiple sclerosis

September 30, 2024

Infliximab

Remicade®

Avsola®
Inflectra®
Renflexis®

Ankylosing spondylitis

Crohn’s disease

Plaque psoriasis

Psoriatic arthritis

Rheumatoid arthritis

Ulcerative colitis

September 30, 2024

Rituximab

Rituxan®

Riabni™

Riximyo®
Ruxience™
Truxima™

Rheumatoid Arthritis

Granulomatosis with polyangiitis (GPA)

Microscopic polyangiitis (MPA)

September 30, 2024

Ustekinumab Stelara®

JamtekiTM

WezlanaTM

Plaque psoriasis August 31, 2025

As new biosimilars become available, the Biosimilar Initiative will also apply to other originator biologics listed on the PEI Pharmacare formulary

How to switch

To give you time to see your health care provider, the originator drugs and the biosimilar versions listed above will be covered until the end of the switching periods. 

Once a switching period has ended, PEI Pharmacare will no longer cover the originator drugs listed above without an approved exemption.

If you use NovoRapid, Lantus or Humalog insulin: 

The switching period has ended (June 30, 2024). Unless you have been approved for an exemption (e.g. insulin pump compatibility), you will no longer have coverage for NovoRapid, Lantus or Humalog insulin.  

If you use Copaxone, Enbrel, Humira, Remicade or Rituxan: 

  • For Copaxone, Enbrel, Humira, Remicade or Rituxan – You will need to switch to a biosimilar before September 30, 2024.
  • For Stelara – You will need to switch to a biosimilar before August 31, 2025 

Your prescriber can help you switch to a biosimilar. They can also answer questions and, if needed, help you enroll in a biosimilar patient support program. 

If your special authorization approval needs to be renewed during the switching period, you will need to be switched to a biosimilar at that time. 

If you don't have an appointment with your prescriber before you special authorization needs to be renewed: 

You or a healthcare provider must complete: 

On this form, you will need to provide the name of the originator biologic you are taking, the name of your prescriber and the date of your appointment with your prescriber. 

If your appointment is scheduled before September 30, 2024, the special authorization coverage for your originator biologic may be extended for 1 month following your appointment date.

Frequently Asked Questions

Is a biosimilar the same as a generic?

No. A generic drug is a simpler molecule and can copy exactly the original brand name medication. 

Biologic drugs are made from live cells and are more complex than traditional drugs. Biosimilar drugs are highly similar to their originator biologic but not an exact copy.

Each batch of a biologic drug can have minor variations from the first biologic that was made. These minor changes can happen with each batch of an originator biologic and with the biosimilar copies, but do not change the effect or safety of the drug.

The biosimilar will work in the same way as the originator biologic.

Are biosimilars safe and effective compared to the originator biologic drug?

Yes, before a biosimilar drug is approved by Health Canada, the manufacturer must show that there are no meaningful differences in safety and effectiveness compared to the originator version. Patients and health care providers can have confidence that biosimilars are effective and safe. 

What is the nocebo effect and how can I prevent it?

A person’s mindset can impact their symptoms and their sense of well-being. When a person’s negative expectations affect the treatment outcomes, this is called the nocebo effect. (When their positive expectations affect treatment outcomes, this is called the placebo effect.)

To prevent a nocebo effect, you can:

  • recognize the possibility of the nocebo effect
  • seek out more information on biosimilars (see Biosimilar Resources for Patients)
  • speak to your doctor, nurse or pharmacist about the switch and discuss your options
  • stay informed about the switch process
  • keep a neutral or positive outlook

If I’m pregnant, can I delay my switch to a biosimilar until after delivery?

Yes. You or a healthcare provider can complete the online biosimilar switching exemption form or the paper biosimilar switching exemption form where you will need to provide your due date. You will need to switch to using a biosimilar within three months after delivery. 

If my insulin pump is not yet shown to be compatible with a biosimilar version of the insulin I use in my pump, can I still get coverage for the originator?

Yes. You or healthcare provider can complete the online biosimilar switching exemption form or the paper biosimilar switching exemption form. You will need to provide the name of the originator insulin you are taking and the make and model of your insulin pump. You will need to switch to using a biosimilar once there is information available to confirm the compatibility of a biosimilar version of your insulin with your pump.

What if I have private coverage?

If you do not rely on PEI Pharmacare drug programs for coverage of your originator biologic, the Biosimilars Initiative will not directly affect you. However, as some private insurance plans have also been implementing biosimilar switch policies, you may wish to contact your private insurer for more information.

For more information

See Biosimilars Resources for Patients or Biosimilar Resources for Health Care Professionals

Email: pei-biosimilar-initiative@gov.pe.ca 

Phone: 902-218-4653
 

Health and Wellness

General Inquiries

Department of Health and Wellness
4th Floor North, Shaw Building
105 Rochford Street
Charlottetown, PE   C1A 7N8

Phone: 902-368-6414
Fax: 902-368-4121

DeptHW@gov.pe.ca