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Biosimilar Drugs

Information and resources on biosimilar drugs for health care professionals.

Oncology biosimilars are entering the Canadian market. Biosimilars are not identical to the reference biologic drug but Health Canada deems the differences not clinically meaningful with respect to quality, safety, and efficacy.

BC Cancer will be implementing biosimilars in fall 2019, starting with bevacizumab biosimilar in gastrointestinal, gynecological, CNS, and sarcoma patients. Trastuzumab and rituximab biosimilars are anticipated to be available in spring 2020.

With the introduction of bevacizumab biosimilar, all existing patients can continue on the reference biologic. Patients starting a regimen containing bevacizumab after the list date of the biosimilar will be administered the biosimilar. For patients on the reference biologic, physicians may choose to switch patients to the biosimilar following discussion with their patients.

Biologic drugs (biologics) are complex protein molecules created inside a living cell. Biologics have become mainstays in the treatment of many types of cancer, including breast, gastrointestinal, lung, ovarian and other cancers. Since biologics are made from living cells, every batch is almost the same but not identical.

 

A reference biologic is the original branded product approved by Health Canada. When the patent for a reference biologic expires, manufacturers can make highly similar copies of the reference biologic, known as biosimilars. In Canada, biosimilars were previously called subsequent entry biologics (SEBs).


A biosimilar is not necessarily identical to its reference biologic, but based on Health Canada’s guidelines and approval standards for the pharmacokinetics, pharmacodynamics, safety and clinical efficacy of biologics, the two are highly similar. There are no clinically meaningful differences between biosimilars and their reference biologics.
 

The active ingredients in generic drugs are exactly the same as the brand name drug, while biosimilars are highly similar but not exact copies. The natural variability and more complex manufacturing of biologics does not allow an exact replication of a biologic molecule.

Biosimilars are regulated as new drugs under the Food and Drugs Act and the Food and Drug Regulations. For a drug to be called a biosimilar, the drug manufacturer must provide information to Health Canada to show that the biosimilar and the reference biologic drug are highly similar, and that there are no clinically meaningful differences in terms of safety and efficacy between them.


Health Canada's decision to authorize a biosimilar for sale is based upon a benefit/risk assessment after considering all of the data submitted by the manufacturer. Health Canada's rigorous standards for authorization mean that patients and health care providers can rely upon the quality, safety and efficacy of a biosimilar, just as for any biologic drug.
 

Yes. Biosimilars have been shown to be equivalent to the reference biologic in properly designed clinical trials. These trials must have a sensitive and homogenous patient population, an appropriate clinical design and useful study endpoints. Biosimilars have been studied in large numbers of patients. As an example, trastuzumab biosimilars have been trialed in six independent Phase 3 clinical trials that had at least 500, and as many as 800 patients in each clinical trial.


Biosimilars work in the same ways as their reference biologic. It is expected that if a patient is transitioned to, or started on, a biosimilar, they will have the same outcome as if they were treated with the reference biologic.
 

Health Canada monitors the safety of all drugs on the market, including biosimilars. Health Canada and manufacturers both play a role in monitoring drug safety.


Health Canada:
  • Conducts market surveillance
  • Monitors adverse reaction reports
  • Investigates complaints and problem reports
Manufacturers:
  • Monitor reported side effects
  • Report any new information received about serious side effects to Health Canada
  • Notify Health Canada about any studies with new safety information
  • Request authorizations for any major changes to the manufacturing process, dose regimen or recommended use of the drug
 

Switching generally refers to a one-time change from a reference biologic drug to a biosimilar but can also refer to a change from a biosimilar to a reference biologic or another biosimilar.

 

Each provincial cancer agency will decide whether to switch patients to biosimilars. Health Canada does not designate any biologic or biosimilar as interchangeable.


At BC Cancer, starting with the introduction of the bevacizumab biosimilar, all existing patients can continue on the reference biologic. Patients starting a regimen containing bevacizumab after the list date of the biosimilar will be administered the biosimilar. For patients on the reference biologic, physicians may choose to switch patients to the biosimilar following discussion with their patients. This is similar to the approach being considered in other provinces.

 

Extrapolation is often used to refer to the authorization (by a regulatory body, like Health Canada) of a drug for indications where clinical studies were not done. For example, subcutaneous rituximab was studied in follicular lymphoma, yet approved for all types of other lymphoma. 


Extrapolation also refers to the use of a drug for indications that are not approved by Health Canada. In some instances, these indications are publicly funded. Health Canada may extrapolate biosimilar indications to indications where clinical studies were not done.

 

Yes. Health Canada states that a biosimilar can have an indication different from what was studied for its approval based on scientific rationale. Health Canada does not make any safety recommendations for off-label use of approved medications. However, certain medications in Canada (e.g. bevacizumab (Avastin)) are funded for indications where there is not an approved indication (cervical cancer). In other regions (e.g., Europe) all indications for the reference biologic are extrapolated to the biosimilar.

 

Biosimilars can save money for the health system. Biologic drugs are very expensive to the health system. In 2016, Canada spent more than $3.6 billion on these drugs. Implementation of biosimilars creates cost savings that can be put back into the cancer system to pay for, and improve access to new treatments.

 

Biosimilars have been in use for more than 10 years in Europe. As of January 2019, Europe has approved almost 60 different biosimilars. Europe has had more than 700 million patient treatment days and has not detected any signals that the products were less safe or efficacious than the reference biologic. The National Health Service has achieved almost 100% uptake of rituximab biosimilar.

 

The first therapeutic oncology biosimilars are expected to enter the Canadian market in 2019.

 

In 2019 to 2020, Canada is expecting biosimilars of bevacizumab (Avastin), trastuzumab (Herceptin) and rituximab (Rituxan).

 
For patient/public information about biosimilars, visit bccancer.bc.ca/biosimilars.

SOURCE: Biosimilar Drugs ( )
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