Health Canada Approves Three New Adalimumab Biosimilars

A year ago (March 10, 2021) we posted about adalimumab having five biosimilars, we are happy to say that number has increased to eight! There are eight biosimilars approved by Health Canada now. The original adalimumab is Humira (Abbvie), and the biosimilars in alphabetical order include: Abrilada (Pfizer), Amgevita (Amgen), Hadlima (Merck), Hulio (Viatris), Hyrimoz (Sandoz), Idacio (Fresenius Kabi), Simlandi (Jamp), and Yuflyma (Celltrion). Bolded are the newest ones. 

As a quick reminder, biologics are protein-based substances that need to be injected/infused, as swallowing them would result in them getting digested in the stomach, which would destroy their effectiveness. Biologics are made by taking a living cell and programming it to make a certain protein, which is very different than how conventional synthetic medications are made. Conventional synthetic medications are based on a very reproducible chemical structure. Biologics, however, are not as easily reproducible because they are grown in a living cell, which results in differences even between batches of the same manufacturer. Companies that want to make a biosimilar need to make their own programmed cell that makes a protein similar to the original biologic.

In order for a company to get a biosimilar approved by Health Canada, the biologic needs to be studied in at least one condition that the original biologic is approved for. Research to prove equal efficacy and safety usually takes 7-8 years, so patients can feel confident using biosimilars for their approved conditions. Additionally, biosimilars have been used safely for multiple conditions around the world for years.  

Biosimilars prove they are equally safe and effective in studies; however, each manufacturer may use their own patented device. There can be differences in these devices which includes if the product is citrate-free, latex-free, and/or and the product’s needle gauge. 

Citrate is a non-medical ingredient that can be found in some injections. Many people do not get discomfort from injections that contain citrate, but some may. This discomfort may happen during the injection, at the injection site. If someone experienced this with Humira (which contains citrate) then choosing a citrate-free biosimilar may be beneficial, but if there was no discomfort while on Humira, this may not be a deciding factor.  

Some individuals have latex allergies, so a deciding factor for those people may be to choose a biosimilar that is latex-free. 

Needle gauge refers to the size of the needle hole. Understanding needle gauge is actually counterintuitive to what you may think. The larger the number, the smaller the needle. So, a size 29-gauge (29G) needle is actually smaller than a 27G needle. There are different reasons needles may be different gauges, but it can be due to the size of the protein or molecule that needs to go through it. As the gauge of the needle increases, there tends to be less discomfort during injection. However, the size difference between a 27G needle and a 29G needle may not be noticeable to most. 

Biologic or BiosimilarCitrate-freeLatex-freeNeedle gauge
Biologic (Original product)
Humira (AbbVie)29
Abrilada (Pfizer)29
Amgevita (Amgen)Needle cover is latex derived27
Hadlima (Merck)29
Hulio (Viatris)29
Hyrimoz (Sandoz)27
Idacio (Fresenius Kabi)29
Simlandi (Jamp)29
Yuflyma (Celltrion)29

Apart from what is in the chart, there are other considerations to be made when deciding which biosimilar to start. These include the biosimilar’s stability at room temperature and the type of autoinjector. Although all these medications need to be stored in the refrigerator, they do have some stability at room temperature, varying between 14-30 days depending on the manufacturer, which may be a consideration for those who travel. Most of the manufacturers have their own patented autoinjectors that differ slightly, but these differences may be important for some people. Many clinics and rheumatologists have demonstrator/training devices of each biosimilar and some individuals may discover they prefer certain devices over others, often due to to personal preference. 

With the approval of the newest biosimilars, it can take some time from them being approved to them being available on the market. Your healthcare providers will be able to guide you through the best selection for you at the time that you begin therapy. 

Marija Ilic is a Pharmacy Student from the University of Waterloo currently doing a rotation at Charlton Health as part of her final year of studies. Through Marija’s education she has gained experience in both hospital and community pharmacy settings and hopes to find a specialized pharmacy role when she graduates. 

This entry was posted in The Charlton Centre. Bookmark the permalink.

Comments are closed.