Biosimilars Initiative for Patients
Coverage for NovoRapid and Humalog is extended up to November 30, 2022, only for people using Medtronic, Tandem, and Ypsomed insulin pumps, and for those using the Omnipod pump with NovoRapid. Coverage policy may change with advance notice.
The Biosimilars Initiative was launched in 2019 to expand health care services in B.C. by switching patients from originator biologic drugs to biosimilar versions shown to be as safe and effective.
The Initiative has successfully switched many PharmaCare patients to an equally safe and effective biosimilar drug approved by Health Canada. Biosimilars are less costly than originators, which means that B.C. can spend money in other areas of our health care system. For example, PharmaCare will be able to cover more drug options.
Each switch period is six months. During that time, patients should talk to their prescriber to get a prescription for the biosimilar in order to keep their PharmaCare coverage. After the switch period ends, PharmaCare only covers the biosimilar version(s).
How do I keep my coverage?
- Make an appointment with your prescriber during the switch period.
- Your prescriber can explain the switch process, discuss your biosimilar option(s), and write you a new prescription. You may also want to talk to your pharmacist.
- Make sure you have a new prescription before the end of the switch period.
Latest biosimilar listings
| March 22, 2022 | |||
|---|---|---|---|
| Drug | Originator | Biosimilar | Conditions include: |
| enoxaparin | Lovenox® Lovenox® HP |
Inclunox®; Inclunox® HP; Noromby®; Noromby® HP; Redesca®; Redesca® HP |
|
| filgrastim* | Neupogen® | Nivestym™ |
|
*Of note: the first filgrastim biosimilar Grastofil® was listed in 2017
Effective March 22, 2022, PharmaCare is de-listing Lovenox and listing biosimilar versions Inclunox, Noromby, and Redesca for the same indications, with the exception of cancer-associated thrombosis (CAT). Existing patients taking Lovenox will keep their PharmaCare coverage until it expires. As of March 22, only enoxaparin biosimilars will be covered for new starts or renewals of prior coverage.
For CAT, Limited Coverage criteria will change. Dalteparin and tinzaparin will both change to first-line treatment (from second-line), removing the requirement for patients to try warfarin first. Enoxaparin biosimilars will also be added as covered first-line treatment options for CAT. The biosimilar listings result in costs savings for the province, which offsets the costs for modifying treatment options for CAT.
Also effective March 22, 2022, PharmaCare is adding a second biosimilar filgrastim called Nivestym to its formulary. Most patients in BC have already successfully transitioned from the originator filgrastim (Neupogen) to the biosimilar Grastofil in 2017. However, a small number of patients who could not transition to Grastofil for reasons such as such as certain dosage formulations not being available, can now safely transition to Nivestym.
Current switch period
| Switching insulin lispro (Humalog®) and insulin aspart (NovoRapid®): November 30, 2021 to May 29, 2022 |
|||
|---|---|---|---|
| Drug | Originator | Biosimilar | Conditions include |
| insulin lispro | Humalog® | Admelog® |
|
| insulin aspart | NovoRapid® | Trurapi® | |
On November 30, 2021, Admelog and Trurapi were added as regular benefits on the PharmaCare formulary. As of December 15, 2021, PharmaCare no longer covers Humalog and NovoRapid for new patients. Only the biosimilar versions (Admelog or Trurapi) are covered by PharmaCare if you are starting on insulin lispro or insulin aspart as of December 15.
From November 30, 2021 to May 29, 2022, PharmaCare covers both versions of insulin lispro (Humalog and Admelog) and insulin aspart (NovoRapid and Trurapi). If you need a new insulin pen, you can order one free of charge from a pharmacy.
Effective May 30, 2022, PharmaCare will no longer cover Humalog and NovoRapid.
If you had coverage for Humalog Mix25, Humalog Mix50 or NovoMix 30 before December 15, 2021, your coverage will not be affected; you will not need to switch.
Coverage extension of Humalog and NovoRapid for patients using certain insulin pumps
| INSULIN PUMP USERS ONLY: Switching insulin lispro (Humalog®) and insulin aspart (NovoRapid®) | |||
|---|---|---|---|
| Insulin pump | Rapid-acting insulin approved for compatible use | PharmaCare coverage | Conditions |
|
Omnipod |
Admelog® (insulin lispro biosimilar—regular benefit) |
Indefinite |
|
|
Omnipod |
NovoRapid® (insulin aspart originator— non-benefit) |
Until November 30, 2022 | |
|
Medtronic Ypsomed Tandem* |
Humalog® (insulin lispro originator— non-benefit) NovoRapid® (insulin aspart originator— non-benefit) |
Until November 30, 2022 |
|
*Tandem insulin pump is also approved for use with Admelog. PharmaCare coverage for this item may change to reflect this compatibility.
Coverage for Humalog and NovoRapid is extended until November 30, 2022, only for those currently using Medtronic, Ypsomed and Tandem insulin pumps. Those using the Omnipod pump with NovoRapid will also be automatically covered until November 30, 2022.
The extension of coverage is automatic, and doesn’t require any additional Special Authority request.
At this time, only the Omnipod pump has been approved by Health Canada for compatibility with Admelog.
For more information, see PharmaCare Newsletter 22-005 (PDF).
If a pump is approved for use with a listed biosimilar before or after November 30, 2022, our coverage policy may change, with advance notice in the PharmaCare Newsletter.
Retail pricing for rapid-acting insulins
PharmaCare has also changed its pricing policy for rapid-acting insulins (RAIs), including the newly added biosimilars. Previously, all RAIs were covered up to a certain amount only. This meant that patients had to pay costs above that amount.
As of November 30, 2021, PharmaCare covers all listed RAIs at the retail price. This includes the biosimilars and insulin glulisine (Apidra®). The change means patients are fully covered for RAIs and the full retail price counts towards any Fair PharmaCare deductible and family maximum, similar to all other insulin products covered by PharmaCare. They no longer have unexpected out-of-pocket costs.
How can I make sure the switch goes well for me?
Your mindset can influence your symptoms and sense of well-being. The nocebo effect is when negative expectations lead to negative outcomes. Misinformation from a variety of sources can cause nocebo effect.
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
What if I can’t switch to a biosimilar?
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.
Can I still switch if the switch period has ended?
Yes, you can switch anytime, but coverage is not retroactive. You would be paying full price for the originator. If you would like to switch to the covered biosimilar, talk to your prescriber.
Through biotechnology, biologic drugs are created from living organisms like yeast and bacteria. Biologics treat patients with serious chronic conditions, including some autoimmune diseases. The first version of a biologic developed is known as the “originator or reference drug.” This is because they are the original version of a drug that a biosimilar is based on.
As patents expire for originator drugs, other manufacturers may produce new, similar versions. These new versions are called biosimilars. Since originator drugs are large and complex, biosimilars can be highly similar, but not identical. Many studies compare biosimilars to the originator drugs and find them to be as safe and effective. Originator drugs have already set the foundation of research and development for biosimilars, which means biosimilar drugs are more cost-effective to produce and lead to similar outcomes.
There are very small differences between different batches of an originator drug. This is because they are made using living organisms with some tiny natural differences. The same goes for the slight differences between a biosimilar and its originator drug, which are also not clinically meaningful.
Drug decision summaries
Other resources
- Health Canada Fact Sheet: Biosimilars
- International Coalition of Medicines Regulatory Authorities Biosimilars Statement (PDF, 625KB)
- Arthritis Consumer Experts Biosim Exchange
- Arthritis Society: Biologics/Biosimilars for the Treatment of Inflammatory Arthritis
- Canadian Digestive Health Foundation
Additional reading
insulin aspart
- CADTH: Switching from Reference to Biosimilar Insulin Aspart for Patients with Diabetes Mellitus (Type 1 or 2)
- Efficacy and Safety of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart in People with Diabetes Treated for 26 Weeks with Multiple Daily Injections in Combination with Insulin Glargine: A Randomized Open-Label Trial (GEMELLI 1)
- Efficacy, Safety, and Immunogenicity of Insulin Aspart Biosimilar SAR341402 Compared with Originator Insulin Aspart in Adults with Diabetes (GEMELLI 1): A Subgroup Analysis by Prior Type of Mealtime Insulin
- Safety and Tolerability of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart (NovoLog) When Used in Insulin Pumps in Adults with Type 1 Diabetes: A Randomized, Open-Label Clinical Trial
insulin lispro
- CADTH: Switching from Reference to Biosimilar Insulin Lispro for Patients with Diabetes Mellitus (Type 1 or 2)
- Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 1 Diabetes Also Using Insulin Glargine-SORELLA 1 Study
- Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 2 Diabetes, Also Using Insulin Glargine: SORELLA 2 Study
- Safety of Insulin Lispro and a Biosimilar Insulin Lispro When Administered Through an Insulin Pump
adalimumab
- CADTH: Switching from reference to biosimilar adalimumab for patients with various inflammatory conditions
etanercept
- Clinical study: Non-medical switch from originator etanercept to biosimilar (rheumatology)
infliximab
- Clinical study: Non-medical switch from originator infliximab to biosimilar (rheumatology)
- ECCO: Position Statement on the Use of Biosimilars for Inflammatory Bowel Disease
- Efficacious transition from reference infliximab to biosimilar infliximab in clinical practice
- NOR-SWITCH study: non-medical switching for all indications, originator infliximab to biosimilar
insulin glargine
- Clinical study: Switching to Insulin Glargine Biosimilar
- Clinical study: Similar efficacy and safety between insulin glargine biosimilar and biologic (Lantus)
rituximab
- Efficacy and safety of switching from rituximab to biosimilar CT-P10 in rheumatoid arthritis
- Long-term efficacy and safety of biosimilar CT-P10 versus innovator rituximab in rheumatoid arthritis
- Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis
- A phase I pharmacokinetics trial comparing PF-05280586 (a potential biosimilar) and rituximab in patients with active rheumatoid arthritis
- Comparative assessment of clinical response in patients with rheumatoid arthritis between PF‐05280586, a proposed rituximab biosimilar, and rituximab
- Extension Study of PF-05280586, a Potential Rituximab Biosimilar, Versus Rituximab in Subjects With Active Rheumatoid Arthritis
- A randomised, double-blind trial to demonstrate bioequivalence of GP2013 and reference rituximab combined with methotrexate in patients with active rheumatoid arthritis
General
- Biosimilars in the EU: Information Guide for Healthcare Professionals
- Patient information: How Biologics and Biosimilars Work
- Drug Discontinuation in Studies Including a Switch from an Originator to a Biosimilar Monoclonal Antibody: A Systematic Literature Review
- Switching Reference Medicines to Biosimilars: A Systematic Literature Review of Clinical Outcomes
Since Initiative was launched in May 2019, many PharmaCare-covered patients have successfully switched from an originator to an approved biosimilar:
- Phase One - 73% of patients transitioned
- Phase Two - 78% of patients transitioned
- Over 90% of PharmaCare patients taking infliximab, etanercept and insulin glargine are now taking biosimilars
| Transition period (if applicable) | Drug (Originator) | Biosimilar(s) | Conditions include |
|---|---|---|---|
| filgrastim (Neupogen®) (January 31, 2017 to July 30, 2017) |
filgrastim (Neupogen®) | Grastofil® |
|
| Phase One (May 27, 2019 to November 25, 2019) |
etanercept (Enbrel®) | Brenzys® |
|
| Erelzi® |
|
||
| infliximab (Remicade®) | Inflectra® |
|
|
| Renflexis® | |||
| insulin glargine (Lantus®) | Basaglar® |
|
|
| Phase Two (September 5, 2019 to March 5, 2020) |
infliximab (Remicade®) | Inflectra® |
|
| Renflexis® | |||
| Rituximab Phase (August 20, 2020 to February 18, 2021) |
rituximab (Rituxan®) | Truxima® |
|
| Riximyo® | |||
| Ruxience™ | |||
| adalimumab (Humira®) and etanercept (Enbrel®) (April 7, 2021 to October 6, 2021) |
adalimumab (Humira®) | Amgevita® Hadlima®* Hulio® Hyrimoz® Idacio® *Hadlima is not indicated for pediatric Crohn’s disease. |
|
| etanercept (Enbrel®) | Brenzys® Erelzi® |
|
|
| insulin lispro (Humalog®) and insulin aspart (NovoRapid®) (November 30, 2021 to May 29, 2022) |
insulin lispro (Humalog®) | Admelog® |
|
| insulin aspart (NovoRapid®) | Trurapi® | ||
| enoxaparin (Lovenox®) (Biosimilars listed March 22, 2022. No switching required. Existing PharmaCare patients taking Lovenox keep their currently approved coverage until it expires.) |
enoxaparin (Lovenox®, Lovenox® HP) | Inclunox®, Inclunox HP® Noromby®; Noromby HP® Redesca®, Redesca HP® |
|
| filgrastim (Neupogen®) (Biosimilar listed March 22, 2022. This is the second filgrastim biosimilar, and no switching is required for most patients). |
filgrastim (Neupogen®) | Nivestym™ |
|
Note: On February 18, 2021, the PharmaCare formulary added Brenzys for the treatment of psoriatic arthritis and the biosimilar infliximab, and Avsola™ for the treatment of ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis.
Biosimilars patient information sheets
- adalimumab
- etanercept
- etanercept–plaque psoriasis
- infliximab
- insulin aspart and insulin lispro
- insulin glargine
- rituximab
If you have questions, contact the Biosimilars team by:
- Phone: 1-844-915-5005 (Monday to Friday, 8:30 am to 4:30 pm)
- Email: Biosimilars.Initiative@gov.bc.ca
