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What you need to know about forced switching

BIOSIMILARS 101

Biologic medicines are used to treat millions of patients with serious illnesses like cancer, arthritis, and psoriasis. When patents expire, copies of biologics enter the marketplace. These are called “biosimilars” because they are highly similar to the original, but not identical.

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FORCED SWITCHING

Which biologic or biosimilar to prescribe is a decision that should be made by physicians, in consultation with their patients. But in some jurisdictions, governments are forcing patients to switch from their physician chosen biologic (or biosimilar) to a government-chosen product – not for medical reasons, but so that governments can save money.

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A BETTER WAY TO FIND SAVINGS

Containing health care costs is important. There’s a better way to reduce costs than forced switching. In the vast majority of countries, the payer continues to reimburse multiple products—biosimilars and biologics alike. In many countries, the physician is encouraged to choose the lowest priced product for new patients.

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CANADA’S PHYSICIANS, PATIENTS OPPOSE FORCED SWITCHING

In a 2017 survey of 403 Canadian physicians:

  • 83% considered it “very important” or “critical” that prescribing physicians decide the most suitable biologic for their patients.

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Resources

FACT SHEET

Read the INESSS report on automatic substitution

Open Letter to Ontario Premier and Deputy Premier/Minister of Health

Joint Statement from the Canadian Association of Gastroenterology and Crohn’s and Colitis Canada

European Physician Perspectives on Biosimilars

Video: Canadian Physicians Oppose Non-Medical Switching

The Argument Against a Biosimilar Switch Policy for Infliximab in Patients with Inflammatory Bowel Disease Living in Alberta

Joint Statement from the Canadian Association of Gastroenterology and Crohn’s and Colitis Canada

FACT SHEET

Read the INESSS report on automatic substitution

Read the GaBI EU markets paper and learn about Europe’s biosimilars success

Joint Statement from the Canadian Association of Gastroenterology and Crohn’s and Colitis Canada

What are Biosimilars?
Biosimilars (also known as follow-on biologics) are sometimes mistakenly called “generic” versions of innovative biologics. However, unlike generics, which are copies of chemically synthesized drugs, biosimilars are similar to, but not the same as the innovator’s active ingredient. This is an inevitable outcome because they do not utilize the same living cell line, production process, or raw material as the innovator drug.
What Are Biologics?
Biologics are complex, large molecule drugs that treat serious illnesses, such as cancer, multiple sclerosis, and rheumatoid arthritis. Unlike drugs derived from chemical synthesis, biologics are manufactured using a unique and proprietary process involving living cells. For this reason, no two biologics made from different cell lines or using different processes will be identical. Biologics are also highly sensitive to the manufacturing process. In fact, altering a single manufacturing parameter can change a compound’s identity or the precise effect it has on the human body. Examples of biologics include the cancer drug Avastin and the arthritis drug Enbrel.

Biotech medicine offers the best hope for some of the most devastating medical conditions, such as Alzheimer’s and Parkinson’s disease, for which there are currently no effective treatments. These drugs are also the fastest-growing segment of the pharmaceutical market and are expected to account for half of the new drugs approved by 2015.

Why Is Patient Safety A Concern?
Biologics raise some safety concerns above and beyond chemical drugs; commensurately, biosimilars are distinct from oral or injected generic drugs. In contrast to most drugs that are chemically synthesized and their structure is known, most biologics are complex mixtures that are not easily identified or characterized. Small differences in the structure of the innovator and the attempted copy can have effects for patients such as reduced efficacy or changes in safety and tolerance.

In order to make informed choices, patients should understand the complexity of these drugs and the difference between oral or injected generics versus biosimilars and talk with their doctors about the best course of treatment.

Mission Statement

It is the mission of the Alliance to serve as an authoritative resource center for the public, medical community, and regulators worldwide as biosimilars policies are developed and implemented.

Who We Are

The Alliance for Safe Biologic Medicines is an organization composed of diverse healthcare groups and individuals—from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. Our membership list and steering committee reflect the wide range of voices within the healthcare community. Our coalition ultimately strives to position itself to be an authoritative resource center of information for the healthcare and policy communities.

We believe patients have the right to expect the same quality in drugs, whether they get the originator product or a biosimilar, irrespective of price.
We believe medical decisions ought to remain between a patient, his or her physician, and the other healthcare professionals from whom the patient receives direct care, not in the hands of third parties such as government payers, pharmacy benefit managers, or private insurers.
We believe that patients need full information about how biosimilars work in order to make informed choices.
We believe that while the ultimate goal is to find a balance between producing economical drugs for our patients and respecting the drug-discovery process, we must never forget that patient safety is paramount.