Charlton Health is proud to announce that the first dose in Canada of the biosimilar adalimumab, known as Amgevita (produced by Amgen), was injected at Charlton Health on February 22, 2021.
Five biosimilars of adalimumab were released onto the Canadian market in February. In alphabetical order they are: Amgevita (Amgen), Hadlima (Merck), Hyrimoz (Sandoz), Hulio (Viatris), Idacio (Fresenius Kabi), and there are still more to come. Humira (Abbvie) is the name of the originator adalimumab, and has had the biggest distribution of any biologic in the world.
Biosimilars are very different from generic medications. When a traditional synthetically made medication loses its patent, another manufacturer is able to copy the chemical structure to make a generic product. Studies are done in a lab setting to ensure the product has the same chemical properties and dissolves in the same manner as the original product in order to be approved by Health Canada. When a biologic medication loses its patent, the process for a second manufacturer to be approved by Heath Canada is quite different. Biologics are not synthetically produced chemical structures; they are made by programming living cells to produce a protein. Even batch to batch, the protein structure can have slight differences. Therefore any manufacturer wanting to replicate a biologic, must develop their own cell line to produce a protein that is as similar as possible to the original product. This biosimilar, must be studied in patients in the same way the original product was researched. The biosimilar must show the same level of safety and efficacy to the originator to be approved.
Biosimilars offer support programs just as the originator biologic, to ensure patients are not limited to medication access due to the cost of the medication. Many biosimilars are produced by innovative companies who have produced originator biologics as well; in fact Amgen, who produced the biosimilar recently injected in our clinic, also produces the originator biologic for etanercept, known as Enbrel. There has been extensive use of biosimilars in Europe. As an example, Amgen’s biosimilar (Amgevita) has been in Europe for over 2 ½ years. Each biosimilar will have its own patented autoinjector device. As devices can each have their own nuances, it is important to have training before starting. Some of the adalimumab biosimilars also have citrate-free formulations, such as the Amgen product. This can make a difference on the comfort of the injection.
There have been several studies based on people switching from an originator product to a biosimilar showing excellent results. It is due to this, that last year, the province of British Columbia has mandated patients on existing biologics for which there is a Health Canada approved biosimilar, make a switch. This has provided significant cost savings. We anticipate this will eventually happen in Ontario. When this is announced, a new prescription must be written by your specialist as this cannot be automatically substituted when a medication is refilled. There will also be time given for such a transition to allow time for a medical visit. We will keep you informed as details are released.
Carolyn Whiskin is the Pharmacy Manager for Charlton Health. Carolyn specializes in the treatment of autoimmune diseases, pharmaceutical compounding, women’s health, pain and smoking cessation. Carolyn has won provincial and national awards for her commitment to patient care and public service.