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How Do Biologics and Biosimilars Work?

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

New policies adopted in public drug programs in Canada

Provincial and Territorial Public Drug Benefit Program

Since prescription drugs prescribed outside of hospital are not covered by provincial health plans, each province and territory offers government drug benefit programs to help people pay for prescription drugs. These programs typically feature specific drug benefit plans for segments of the population that require more coverage for high drug costs. These may include seniors, individuals on social assistance, and persons with diseases or other conditions associated with high drug costs.

Please note: for more details on the public drug benefit program in your province or territory, please visit: Provincial and Territorial public drug benefit programs

For more information about how prescription drugs are accessed in Canada visit: www.canadianpsoriasisnetwork.com/treatments-canada/prescription-drugs

For people enrolled in public drug plans for biologics that have lost their patent, certain provinces have initiated new policies which involve people changing from biologic drugs to their biosimilar versions.

For more information visit:

Federal Public Drug Benefit Programs

The Government of Canada provides prescription drug coverage through numerous programs to approximately one million Canadians. Those who may be eligible include First Nations and Inuit peoples, members of the Canadian Armed Forces, qualified veterans, members of the Royal Canadian Mounted Police and offenders in federal correctional institutions.

Though the exact cause of chronic inflammatory conditions like psoriasis is unknown, dynamic factors and processes that drive inflammation include over-activated immune cells and cell signalling chemicals called cytokines . Biologic and biosimilar drugs (going forward referred to as biologic agents) target specific cytokines to suppress their overproduction and to bring the immune system back to normal (see figure below).

Cytokines that are known to be involved in inflammation in psoriasis and psoriatic arthritis include tumour necrosis factor, interleukin 17, interleukin 12 and interleukin 23.  Each of these molecules are specific messengers in the immune system involved in the development of psoriasis.

Tumour necrosis factor (often called tumor necrosis factor alpha or TNF)

TNF is a cytokine with its primary role in the regulation of immune cells. When immune cells detect an infection, they release TNF to alert other immune system cells as part of an inflammatory response. A TNF blocker (or inhibitor) is a biologic drug that aims to reduce the activity of, or physiological response to, TNF to reduce or eliminate inflammation. The TNF blockers used for moderate-to-severe forms of plaque psoriasis and psoriatic arthritis are adalimumab, etanercept, infliximab and certolizumab pegol. Golimumab is a TNF blocker indicated to treat moderate-to-severe psoriatic arthritis. TNF blockers are broad-acting agents, as TNF is an upstream mediator of inflammation, meaning that it comes earlier in the inflammatory signalling process for psoriatic disease. The dosing regimen, side effect profiles and other special considerations may differ, depending on the drug.

Interleukin 12(IL-12) and Interleukin 23 (IL-23)

Interleukins (ILs) are a group of cytokines that are released by white blood cells.

The IL-12/IL-23 pathway plays a significant role in the initiation of inflammation in adaptive immune responses. In particular, IL-23 helps to transform naïve T helper cells into Th17 cells which then release several inflammatory cytokines including IL-17; IL-12 helps with the Th1 division and production of cytokines such as interferon-γ and tumour necrosis factor (TNF). The dosing regimen, side effect profiles and other special considerations may differ, depending on the drug.

The only IL-12/23 blocker available is ustekinumab. It is used for moderate-to-severe forms of plaque psoriasis and psoriatic arthritis.

The IL-23 blockers are the newest class of biologics in the treatment of psoriasis. They include risankizumab, guselkumab, and tildrakizumab which are all available in Canada to treat moderate-to-severe plaque psoriasis and, in the case of guselkumab, psoriatic arthritis.

The dosing regimen, side effect profiles and other special considerations may differ, depending on the drug.

Interleukin 17

Interleukins (ILs) are a group of cytokines that are released by white blood cells.

Interleukin 17 is a family of pro-inflammatory cytokines that are produced by a type of T helper cells (a type of white blood cell) known as T helper 17 cell in response to their stimulation with IL-23. IL-17 blockers (or inhibitors) include secukinumab, ixekizumab, and brodalumab and they treat moderate-to-severe forms of plaque psoriasis and psoriatic arthritis. IL-17 cytokines are important for the immune function of barrier tissues including the skin, the lungs and the gastrointestinal tract. Patients with active chronic inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis) should not receive IL-17 blockers because of potential aggravation of these conditions. The dosing regimen, side effect profiles and other special considerations may differ, depending on the drug.

Abatacept

Abatacept is used to treat psoriatic arthritis. It does not block cytokines like TNF but rather attaches to the surface of inflammatory cells and blocks communication between these cells. By blocking this communication, abatacept lessens inflammation. Though it can be a first-line treatment, abatacept is often prescribed when patients with moderate to severe psoriatic arthritis who have not responded to one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate, or other biologic drugs.

Since many factors are involved in chronic inflammation, what drives this process in one individual may differ from another individual with the same chronic illness or at different stages of disease. A single biologic agent that resolves inflammation in one patient may not work to the same degree as another patient with the same disease or may lose its efficacy for an individual over time.

Moreover, many factors go into making treatment decisions – including topicals, phototherapy, systemic drugs and biologic agents – throughout a patient’s life. Factors to consider include insurance coverage, mode of delivery (systemic versus topical; intravenous injection versus subcutaneous injection versus oral), dosing profile, family planning and/or potential for pregnancy, medical history and comorbidities.

Treatment factors to consider

At this stage, since we do not have biomarkers that can predict which drug will work best in an individual patient with psoriasis or psoriatic arthritis, there is a certain level of trial and error to find the right treatment for the right individual over the course of their condition. Individuals may respond to one biologic agent, and not another even within the same class (e.g., TNF blockers; IL-17 blockers etc.) and/or treatment can work for a certain amount of time and then lose its efficacy in an individual.

Many factors go into deciding which treatment – including topicals, phototherapy, systemic drugs and biologic agents – is right for the individual throughout a patient’s life. Factors to consider include insurance coverage, mode of delivery (systemic versus topical; intravenous injection versus subcutaneous injection versus oral), dosing profile, family planning and/or potential for pregnancy, medical history and comorbidities.

Moreover, some biologics may be preferred over others for certain types/locations of psoriasis (such as scalp psoriasis, nail psoriasis, genital psoriasis and palmoplantar disease).

Ongoing shared decision making between a patient and their dermatologist/rheumatologist/healthcare team is crucial in ensuring that a person gets the care, treatment and support that they need to live well with psoriatic disease.

TNF Blockers

Last updated November, 2021.

Disclaimer

This Site was designed for educational purposes only and not for the purpose of rendering medical advice. Individual variances in psoriasis cases require the consultation of a physician to make sound medical decisions. The information presented on this website is not intended to replace the counsel of your physician. It is important to see your doctor before altering anything in your treatment plan. The Canadian Psoriasis Network does not endorse any medications, products, equipment or treatments for psoriasis and psoriatic arthritis. Any of the information contained within the Canadian Psoriasis Network’s Site is not presented as a substitute for informed medical advice. Visitors to this site should not engage in self-diagnosis nor act on information contained in the Site without seeking specific advice on the particular matters which are of concern to them from qualified health professionals and advisors. Some of the information contained in the Site has been provided from external sources. While efforts have been made to ensure the accuracy, currency, and reliability of the content, the Canadian Psoriasis Network accepts no responsibility in that regard. Please refer to our Terms of Use for further details.

This resource was made possible through support from:

Abbvie
Pfizer
Janssen
Bausch
 
LEO Pharma
Novartis
Amgen

 

Cytokines are small proteins that control the growth and activity of other immune system cells and blood cells. When released, they signal to the immune system to do its job. Cytokines affect the growth of all blood cells and other cells that help the body's immune and inflammation responses.

A type of T cell that play an important role in the immune system, particularly in the adaptive immune system. When stimulated by a specific antigen (foreign substance) they "help" the activity of other immune cells by releasing cytokines, small protein mediators that alter the behavior of target cells that in turn, express receptors for those cytokines. Subsets of Th cells (e.g., Th1, Th17) produce different cytokines.

A subsystem of the immune system that is made up of specialized, systemic cells which process and eliminate germs (e.g., bacteria and viruses) or prevent their growth. The adaptive immune system "remembers" germs, so the next time a known germ is encountered, it can respond faster (known as immunological memory). Antibodies are a critical part of the adaptive immune system. By specifically targeting the type of germ that is causing the infection, the adaptive immune system takes over if the innate immune system – the body’s first line of defence that doesn’t distinguish between different germs – is not able to destroy the germs. For this reason, the adaptive immune system is slower to respond than the innate immune system, but when it does, it is more accurate.

Cytokines are small proteins that control the growth and activity of other immune system cells and blood cells. When released, they signal to the immune system to do its job. Cytokines affect the growth of all blood cells and other cells that help the body's immune and inflammation responses.

A subsystem of the immune system that is made up of specialized, systemic cells which process and eliminate germs (e.g., bacteria and viruses) or prevent their growth. The adaptive immune system "remembers" germs, so the next time a known germ is encountered, it can respond faster (known as immunological memory). Antibodies are a critical part of the adaptive immune system. By specifically targeting the type of germ that is causing the infection, the adaptive immune system takes over if the innate immune system – the body’s first line of defence that doesn’t distinguish between different germs – is not able to destroy the germs. For this reason, the adaptive immune system is slower to respond than the innate immune system, but when it does, it is more accurate.

A type of T cell that play an important role in the immune system, particularly in the adaptive immune system. When stimulated by a specific antigen (foreign substance) they "help" the activity of other immune cells by releasing cytokines, small protein mediators that alter the behavior of target cells that in turn, express receptors for those cytokines. Subsets of Th cells (e.g., Th1, Th17) produce different cytokines.