Biologics and Biosimilars

About biologics

Biologics are cutting-edge drugs made from living organisms and their cells. There are several biologics approved for the treatment of moderate-to-severe psoriasis and psoriatic arthritis. Biologics are usually prescribed to patients who have not responded well to other forms of treatment such as oral systemic therapy (like methotrexate) and/or phototherapy. These drugs are administered by injection under the skin (subcutaneous injection) and occasionally by infusion. The frequency of treatment depends on the type of biologic the patient is prescribed.

Unlike traditional drugs that impact the entire immune system, biologics are highly complex molecules that work by blocking interactions between certain immune system cells and inflammatory pathways that are responsible for causing symptoms of psoriasis and psoriatic arthritis. Each class of biologics targets a different pathway to reduce pain and improve function. Classes of biologics for psoriatic disease include TNF blockers, IL 17 blockers, IL 12/23 blockers, and IL 23 blockers. If one biologic doesn’t work or loses its efficacy, another biologic may prove to be effective instead.

Though these medications target only parts of the immune system, they can increase susceptibility to infection. When taking a biologic, it is important that you have regular check-ups with a dermatologist, rheumatologist, or a physician who has expertise in the use of these treatments.

About biosimilars

Biosimilars are brand name drugs that are similar, but not identical, to existing biologic drugs that have already been authorized for sale. They become available after the patent of the original biologic drug expires. There are no meaningful clinical differences between the two and biosimilars are approved at the same standards of quality, safety and efficacy as biologic drugs. Biosimilars are typically less expensive than their reference biologic product, making them a suitable alternative for many patients.

Biosimilars and generic drugs are not the same. Generic drugs are made of small molecules that are chemically synthesized and are molecularly identical to their brand-name reference products. Due to the size, complexity, and natural variability of biologic drugs, biosimilars cannot be considered identical.

Regulations of biologics and biosimilars in Canada

Biologics and biosimilars must undergo rigorous testing by Health Canada and show sufficient scientific evidence before they can be considered for approval. Biologic drugs are listed in Schedule D of the Food and Drugs Act. Health Canada and the Public Health Agency of Canada continuously monitor any adverse effects, maintain post-approval surveillance and handle any necessary recalls.

Biosimilars are listed as new drugs under the Food and Drugs Act and the Food and Drugs Regulations and are manufactured to the same regulatory standards as other biologic drugs. Canada has developed a thorough regulatory framework for authorizing biosimilars for sale, meaning you can have the same confidence in the regulatory process around quality, safety and effectiveness as any other biologic drug.

For more information on Canada’s regulations, please visit: Health Canada Biosimilar Biologic Drugs