Biosimilars Initiative for Patients

Biologics are drugs that are engineered using living organisms like yeast and bacteria. They are used to treat patients with serious conditions, including some autoimmune diseases. The first version of a biologic developed is also known as the “originator drug” because they are the original composition of a biologic drug that a biosimilar is based on.

As patents expire for biologic drugs, other manufacturers may produce new versions of the biologic drugs called biosimilars. Biosimilars are highly similar to the originator drug and have been shown to have no clinically meaningful differences in safety or efficacy. Since originator biologic drugs have already set the foundation of research and development for biosimilars, biosimilar drugs are more cost-effective to produce and lead to patient outcomes that are no different from the originator drug. This is similar to generic drugs, but because the molecules involved in biologics are so complex, there is no way to determine if they are identical to the originator drug in the same way that the active ingredients in generics are identical to those in the brand name drugs.

The three originator drugs affected represent some of the province’s largest drug expenditures. Replacing certain originator drugs with their biosimilar versions for PharmaCare will result in major cost savings to our health care system, and will provide better access to drugs that people need without compromising drug effectiveness.

Health Canada finds no meaningful differences (physiochemical structure, quality, potency, pharmacokinetics, and immunogenicity) between biologics and biosimilars, and supports the safety and efficacy of an approved biosimilar drug.

Etanercept

Biologic	Biosimilar	Treats
Enbrel ®	Erelzi ™	Ankylosing spondylitis Psoriatic arthritis Rheumatoid arthritis
	Brenzys ®	Ankylosing spondylitis Rheumatoid arthritis

Enbrel is the brand name for the biologic version of etanercept. Erelzi and Brenzys are the brand names of the biosimilar versions of etanercept.

Patients who use etanercept are affected by the Biosimilars Initiative if:

• They are covered by PharmaCare, and
• They are using the Enbrel brand, and
• They are being treated for ankylosing spondylitis, psoriatic arthritis, or rheumatoid arthritis

Affected patients must visit their prescriber and depending on the affected indication, switch to Brenzys or Erelzi before November 26, 2019 to receive continued PharmaCare coverage. Of the two etanercept biosimilars, only Erelzi is currently indicated for psoriatic arthritis.

PharmaCare will cover all three brands of etanercept between May 27 and November 25, 2019 to give patients time to switch over. After the switch period, only the Erelzi and Brenzys brands will be covered.

For some patients, it may be medically necessary to continue using Enbrel. In this case, your prescriber must determine the medical requirement and request exceptional Special Authority approval for continued coverage of Enbrel.

Note: If you take Enbrel for plaque psoriasis, you will not be affected by biosimilar switching at this time.

Infliximab

Biologic	Biosimilar	Treats
Remicade ®	Inflectra ®  Renflexis ®	Ankylosing Spondylitis Plaque Psoriasis Psoriatic Arthritis Rheumatoid Arthritis

Remicade is the brand name for the biologic version of the drug infliximab. Inflectra and Renflexis are brand names of the biosimilar versions of infliximab.

Patients taking infliximab are affected by the Biosimilars Initiative if:

• They are covered by PharmaCare, and
• They are taking Remicade, and
• They are being treated for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or plaque psoriasis

Affected patients must switch to using a biosimilar version of their medication by November 25, 2019 to receive continued PharmaCare coverage. Between May 27 and November 25, 2019, PharmaCare will cover all three brands (biologic and biosimilar) of infliximab to provide time for switching. Remicade will not be covered after the switch period.

If you cannot switch to a biosimilar due to a medical reason, your prescriber may request Special Authority approval to consider continuation of Remicade coverage.

Note: If you take Remicade for Crohn’s disease or ulcerative colitis, biosimilar switch dates will be announced at a later date.

Insulin Glargine

Biologic	Biosimilar	Treats
Lantus ®	Basaglar ™	Diabetes (Type 1 and 2)

Lantus is the brand name of the biologic version of insulin glargine. Basaglar is the brand name of the biosimilar version of insulin glargine.

The Biosimilars Initiative affects patients who:

• Are using the Lantus brand of insulin glargine, and
• Are covered by PharmaCare, and
• Are being treated for diabetes (type 1 or 2)

Affected patients must switch to Basaglar before November 26, 2019. Between May 27 and November 25, 2019, PharmaCare will cover both brands of insulin glargine, however only Basaglar will be covered after the switch period ends.

If your prescriber determines it medically necessary for you to remain on Lantus, the prescriber may submit a Special Authority request to approve continued coverage of Lantus.

Note: If you are a Plan W beneficiary, you will not need to switch to Basaglar.

If the Biosimilars Initiative affects you:

• Make an appointment with your prescriber before November 26, 2019
• Discuss the switch with your prescriber and pharmacist
• Your prescriber can explain the switch process, discuss your biosimilar options, and write you a new prescription
• Ensure you switch before November 26, 2019 to maintain your PharmaCare coverage.

For more information, see:

• Biosimilars patient information sheets:
  • etanercept
  • infliximab
  • insulin glargine
• Biosimilars FAQ for Patients
• Drug Decision Summaries for:
  • etanercept
  • infliximab
  • insulin glargine
• Health Canada Fact Sheet: Biosimilars
• Arthritis Consumer Experts Biosim Exchange

Evidence and additional reading:

• The Arthritis Society: Biologics/Biosimilars for the Treatment of Inflammatory Arthritis
• Biosimilars in the EU: Information Guide for Healthcare Professionals
• Clinical study for: Switching to Insulin Glargine Biosimilar
• Drug Discontinuation in Studies Including a Switch from an Originator to a Biosimilar Monoclonal Antibody: A Systematic Literature Review
• Efficacious transition from reference infliximab to biosimilar infliximab in clinical practice
• Switching Reference Medicines to Biosimilars: A Systematic Literature Review of Clinical Outcomes

If you have any further questions about biosimilars, contact PharmaCare at Biosimilars.Initiative@gov.bc.ca