Biosimilars

Newcomers are entering the world of rheumatology: biosimilars. Since the original biological treatments are expensive and are increasingly used to control the symptoms of arthritis, pharmaceutical companies are working to create "similar copies" to reduce costs for patients and society in general.

Innovative biological treatments, the originals if you prefer, are the result of a lot of work. The molecule must be further developed through research during creation, before marketing, and especially afterwards, to ensure that the treatment is safe and effective.

Biosimilars are also the result of considerable work, but their cost of production is lower. The research done for these molecules is focused before their marketing phase to ensure that the product is up to standard, therefore resulting in lower costs. Studies are in progress, after the marketing phase, to help us better understand their impact on a daily basis. Biosimilars can be developed only when the patent of the innovative treatment, the biological one, comes to an end.

With the arrival of biosimilars, competition among pharmaceutical companies is expected to increase and significantly lower prices for these types of treatments. The patients will benefit from these price cuts. Treatments will still be expensive, so you will have to meet the same criteria as the original treatments to gain access to the biosimilars.

These drugs are different from a single generic because unlike generics, they contain living cells (antibodies). Here is a chart to help you understand.

Biosimilars need to prove their similarity to the original product and meet several criteria before going on the market.  Health Canada has a lot of requirements for them.

 

They must:

- have the same action mechanism; they must act the same way;

- have the same structure; the same antibodies must be present;

- have conclusive clinical results: they are neither superior nor inferior to the original product, and are as effective;

- have the same safety level as the original product;

- have the same purity as the innovative treatment;

- generate the same immune response.

They are designed in several stages and the pharmaceutical companies must make sure they obtain the characteristics of the reference biological drug. In a way, it’s as if a clone of the original molecule was created.

At this point, there is still some unknown data, such as the possibility of substituting biosimilars without the risk of losing the efficacy of the treatment or of provoking an unfavourable immune response for the same patient. Many pharmaceutical companies are going to launch their own version of the original product, so in the next few years we may find several copies of Remicade, Enbrel, Rituxan and Humira. Each product is attached to a support program, so it will be necessary to find a way for patients to receive the necessary support if the supplier changes with each renewal.

The experience with these treatments is more and more reassuring. Biosimilars have been used in 66 countries since 2012. In Canada, these products have been approved by Health Canada since 2014. For now, there is no evidence of a poor response to biosimilars.

Currently, Health Canada does not want the drugs to be interchangeable or substituted. The person treated with a given biosimilar should therefore always receive the product prescribed by their doctor. Studies are also underway to learn about the long-term side effects of molecule exchanges. We will have to wait a while longer to confirm that this is possible without impacting your response to treatment and your overall health.

At this point, the decision to go for an innovative treatment rather than a biosimilar is up to the patient and his doctor, after a good discussion to be able to make an informed decision.

To learn more about the mechanism of action, side effects or other, please refer to the biologics page. The information it contains also applies to biosimilars.

For a complete list of side effects that may occur with biosimilars, refer to the product monography, or by clicking on the buttons next to the names of medications where you will be able to consult the descriptive sheets issued by the Arthritis Society (AS) and by Rheuminfo (RI).

 

If you are curious and want to know more, here are some links that may interest you:

 

Health Canada: You can read the documentation here

The Jointhealth site offers you a document that you can consult here.

You can also see the following videos to better understand what a biosimilar is:

 

The Healthchoicefirst website offers a video that you can view here.

The Canadian Arthritis Patient Alliance (CAPA) website has a video that you can see here.

Here is another video to help you understand the concept of biosimilars. You can watch it here.

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© 2016 Institut de Rhumatologie de Montréal

révision Septembre 2018.

L'IRM remercie Abbvie, Amgen, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi et UCB pour leur support.

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