Biosimilar drugs

Overview

A biosimilar drug is a highly similar but less expensive version of the original biologic medication, known as an originator drug.

Alberta’s Biosimilar Initiative will expand the use of biosimilars by replacing the use of biologic drugs with their biosimilar versions whenever possible. This means patients will continue receiving the same safe and effective treatment, but at a lower cost.

Adult patients, except pregnant women, currently taking a biologic drug that has a biosimilar version for their medical condition must switch to the biosimilar drug prior to the switch date.

Under Alberta’s government sponsored drug plan, biologic drugs cost more than $262 million in the 2019-20 fiscal year, and are going up an average 13.9% per year. The originator biologic drugs Remicade, Humira and Enbrel are 3 of the top 4 drivers of drug spending in Alberta.

Switching to biosimilars is anticipated to save between $227 million and $380 million over 4 years once fully implemented. These savings can be invested into other health care services for Albertans.

Biologic drugs affected

Only the biosimilar versions of the originator biologics listed below will be covered by Alberta government drug plans after the switch date.

Patients who are taking originator biologics for the health conditions listed must switch to the biosimilar version of the drug.

Table 1: Biologic drugs list¹

¹ Patients under the age of 18 years are not required to switch to the biosimilar at this time.
Drug name	Originator brand name	Biosimilar brand name	Health conditions	Switch date¹ – Patients must switch to the biosimilar version by:
Enoxaparin	Lovenox	Inclunox Noromby Redesca	Thromboembolic disorders	January 10, 2022
Insulin lispro	Humalog	Admelog	Diabetes	February 1, 2022
Insulin aspart	NovoRapid	Trurapi	Diabetes	April 1, 2022
Adalimumab	Humira	Amgevita Hadlima Hulio Hyrimoz Idacio	Ankylosing Spondylitis Plaque Psoriasis Hidradenitis Suppurativa Psoriatic Arthritis Rheumatoid Arthritis Crohn’s Disease Ulcerative Colitis	May 1, 2022

Switching to a biosimilar

Patients should contact their health care professional to discuss switching. Your health care professional can:

answer questions about switching from an originator biologic drug to a biosimilar
explain the process for switching
discuss biosimilar options
write a new prescription, if needed
enrol you in a new patient support program, if needed

If you are unable to switch to the biosimilar version for medical reasons, your health care professional can help determine whether to request exceptional coverage of the originator biologic.

Biologics and biosimilars

Biologics are drugs manufactured in, extracted from, or semi-synthesized from living cells through a highly complex manufacturing process.

A biosimilar is highly similar to the first biologic drug that was authorized for sale called an 'originator biologic.' Due to the complexity of biologic drugs and the natural variability that results from using living cells, it is not possible for a biosimilar to be identical to its originator biologic drug, nor is it possible for different lots or 'batches' of an originator biologic drug to be identical. These variations are not clinically meaningful.

Safety and effectiveness

The biosimilars included in Alberta’s Biosimilars Initiative are approved by Health Canada.

Health Canada reviews and approves all drugs before they can be sold in Canada. Biosimilar drugs undergo a rigorous review process and must demonstrate they are highly similar to the biologic drug.

Biosimilars have been used in Canada, Australia, the United States, the United Kingdom and the European Union for more than 10 years. Many European nations have required patients to switch to biosimilars under publicly funded drug plans.

Patients and health care professionals can have confidence that biosimilars are effective and safe for each of their authorized indications. Numerous research studies collectively show little to no difference in safety and efficacy when patients switch to a biosimilar.

Research studies

Safety and effectiveness citations

“Patients and health care professionals can have confidence that biosimilars are effective and safe for each of their authorized indications. No differences are expected in efficacy and safety following a change in routine use between a biosimilar and its reference biologic drug in an authorized indication.” – Biosimilar biologic drugs in Canada: Fact Sheet, 2019, Health Canada

“Over the past 10 years, the EU has approved the highest number of biosimilars worldwide, amassing considerable experience in their use and safety. The evidence acquired over 10 years of clinical experience shows that biosimilars approved through EMA can be used safely and effectively in all their approved indications as other biological medicines. Over the last 10 years, the EU monitoring system for safety concerns has not identified any relevant difference in the nature, severity or frequency of adverse effects between biosimilars and their reference medicines.” – Biosimilars in the EU: Information Guide for Healthcare Professionals, European Medicine Agency (PDF, 1.9 MB)

“The council recommends formulary management policies, including requiring biosimilar substitution that support the use of biosimilars and encourage patients and prescribers to choose the most cost-effective therapies to ensure the sustainability of national pharmacare. Prescribers and patients should be better supported with information reinforcing the safety, efficacy and benefits of biosimilars.” – A Prescription for Canada: Achieving Pharmacare for All, Final Report of the Advisory Council on the Implementation of National Pharmacare, June 2019, Advisory Council on the Implementation of National Pharmacare

“More than 100 research studies exist on patients with inflammatory arthritis, gastrointestinal and skin disease who have successfully policy transitioned from a TNF inhibitor biologic originator to its TNF inhibitor biologic biosimilar.”

“Like any medicine approved by Health Canada, biosimilars can be expected to be safe and effective treatment options when they are used appropriately in their approved indications.”– Biosimilars in Canada: What inflammatory arthritis patients need to know, Arthritis Consumer Experts (PDF, 4.6 MB)

“Are biosimilars safe and effective? Yes. Health Canada reviews and approves all drugs before they can be sold in Canada. Health Canada also has rules about how all drugs are manufactured. All companies selling drugs in Canada must follow the same rules for the manufacturing process and for ensuring the quality of their ingredients.” – Biosimilar Drugs: Your questions answered, Canadian Agency for Drugs and Technologies in Health (PDF, 162 KB)

“Do biosimilars work as well as reference biologic drugs? Yes, because reference biologic drugs and biosimilars work the same way. If you were taking a reference biologic drug and are now taking a biosimilar drug, you should expect to have the same results and the same side effects.” – Biosimilars: What you need to know, Cancer Care Ontario

“Are biologics/ biosimilars safe? Health Canada is responsible for making sure that all new drugs, including biologics and biosimilars, are safe, effective and of high quality.
Health Canada evaluates all the information provided to confirm that the biosimilar and the original biologic drug are similar and that there are no clinically meaningful differences in safety and efficacy between them.” – Arthritis Society

“Biosimilars are made with the same types of natural sources as the original biologic they were compared to — and provide the same treatment benefits.” – Biosimilar Basics, U.S. Food and Drug Administration
Cost citations

“Biosimilars could offer yearly savings of $1.8 billion.” – Patented Medicine Prices Review Board

“Manitoba and Alberta had the highest levels of biologic-related costs relative to total drug costs in 2016/17.” – Compass Rx, 4th edition, Annual public drug plan expenditure report, Patented Medicine Prices Review Board

“We performed a retrospective analysis of Canadian drug purchases for filgrastim, infliximab and insulin glargine from July 2016 to June 2018…In total $1,048,663,876 Canadian dollars in savings could have been realized with 100% use of biosimilars over the originator products during this 2 year time period.” Alberta’s unrealized savings: $138,074,937 – Potential cost-savings from the use of the biosimilars filgrastim, infliximab and insulin glargine in Canada: a retrospective analysis, University of Saskatchewan, BMC Health Services Research

Contact

To learn more about Alberta’s Biosimilars Initiative, connect with Alberta Blue Cross:

Hours:
8 am to 8 pm (Monday to Friday)
9 am to 5 pm (weekends and holidays)
Phone: 1-800-661-6995 (General Alberta Biosimilar Initiatives)

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Popular topics:

Biosimilar drugs

Table of contents

Overview

Biologic drugs affected

Switching to a biosimilar

Biologics and biosimilars

Safety and effectiveness

Research studies

Contact

Table of contents

Overview

Biologic drugs affected

Switching to a biosimilar

Biologics and biosimilars

Safety and effectiveness

Research studies

Safety and effectiveness citations

Cost citations

Contact