Well before the advent of prescription drugs, since the early days of man, people had been using medicinal plants, herbal teas, decoctions, poultices and other products found in nature. Medicine hails to a much more recent time. The day came when man decided become the artisan and creator of chemical compounds capable of providing relief and/or a cure.
In 1976, practices would change radically. Chemical synthesis would give way to the manufacture of biological drugs. A young American company used biotechnology to revolutionize the process used to manufacture insulin. By modifying the DNA of certain microorganisms and by transferring genes coding for the production of insulin in humans, it became possible to quickly and efficiently synthesize human insulin. This novel approach, the brainchild of Herbert Boyer, researcher and co-founder of Genentech, ushered in a new era in drug manufacturing.
According to Health Canada: "Biologic drugs come from living organisms or from their cells, and are often made using biotechnology. They are used to treat diseases and medical conditions including anemia, diabetes, inflammatory bowel disease, psoriasis, rheumatoid arthritis, hormone deficiency and some forms of cancer. Biologic drugs are generally larger and more complex than chemically produced pharmaceutical drugs." (Ref.: Health Canada Fact Sheet: Biosimilars)
The life of a biologic drug
As mentioned in a previous article, it takes about 10 to 15 years of research from the concept of compounding a biologic drug and its availability to the public. At that point in time, the drug is patented and no copies may be made for a certain period of time. Once the patent expires, a similar product can be manufactured and released on the market. This is known as a biosimilar drug, or a subsequent entry biologic (SEB).
This is not an exact copy of the biologic drug since it is impossible to exactly copy what a living organism can produce. It is not a chemical compound where the formula can be reproduced. Remember, this is a product generated through the action of living cells or organisms. This drug is significantly more complex than a product manufactured chemically. This is why the term "generic" or "copy" is no longer used, but rather bio "similar." It resembles a biologic drug but an identical correspondence between the biologic drug and the biosimilar is not possible.
It's somewhat like siblings. They can have many similarities since they share several hereditary factors, but they are not identical twins. And, technically speaking, even identical twins are not 100 per cent identical in every respect. There are differences between them, just as in the natural world, no two snowflakes are alike. Biosimilars are therefore not copies of biologic drugs; they are similar, but not identical. So why the need for biosimilars?
Reasons for the change
The most valid -- though least common -- reason may pertain to treatment results. Let's assume that the treatment does not have the anticipated success; other drugs will then have to be tried, some of which may include biologic drugs and biosimilars.
However, most of the time the reason for the change is a less noble one, one that involves money. In a document entitled "Regulatory impact assessment. Bill 92: An Act to extend the powers of the Régie de l'assurance maladie du Québec and amending various legislative provisions" produced by the Ministère de la santé et des Services sociaux tabled on Nov. 14, 2016. page 15, item 2.1 states:
"Moreover, it is important to favour the introduction on the market of SEBs (note: read biosimilar drugs) by implementing a reimbursement scheme that gives preference to SEBs over biologics. (...) this change will enable the Minister to limit, where appropriate, the coverage granted by the Basic Prescription Drug Insurance Plan to SEBs only for patients who have never been given the brand-name product. Selected based on conclusive data, the Minister may also limit the coverage under the Basic Prescription Drug Insurance Plan to only SEBs, even for patients who have already started treatment with the reference biologic drug."
And what about the patient?
Naturally, the minister must take budgetary requirements into consideration; however, when comes time to choose, does the patient's perspective carry any weight? At a time when patients are being increasingly asked to become proactively involved in their health, why would this no longer apply when the choice of medication is involved? Patients these days have access to a wealth of information and can establish a dialogue with their attending physician and his specialists to determine the best therapeutic courses of treatment with full knowledge of the facts.
Furthermore, if, for some, the change from biologic to biosimilar drugs has only little or no noticeable effects, for others the change involves going back to square one. Mel Wong, president of BioAlberta, an organization that promotes life and health sciences in Alberta, mentioned that for a good many people, the advent of a new medication is the only efficient treatment for their health issue. Let's take the example of persons with Crohn's disease. For years, they had to live with all the limitations and pain that came with the disease.
A new biologic drug that suppresses the symptoms and the unbearable flare-ups of the disease may mean, for the first time in their life, the end to their pain and even a return to the workforce. In reality, on one end of the scale there is a suffering person who is housebound and unable to work, and at the other end, there is a person who has been freed from their suffering and is capable of assuming their role in society. In short, a life of suffering and dependence versus a life without suffering and with gainful employment. And this is also why we are not surprised to learn in a project report on biosimilars dated March 17, 2017 that many patients are worried about the change from biologic drugs to biosimilars imposed by the government.
This report was written by five patient organizations who got together to make the project possible: Canadian Arthritis Patient Alliance; Canadian Psoriasis Network; Crohn's and Colitis Canada; Gastrointestinal Society and the Arthritis Society (in charge of the project).
Here is the moving story of Gail, a resident of Toronto, who says: "The road has been a difficult one. The situation is not perfect, but changing medications for non-medical reasons scares me. I had to stop taking my biologic drug to undergo an operation, and when I started taking it again, I had a severe allergic reaction. I had to stop taking it."
Another person from Vancouver relates the following: "When you find a treatment that works after many drugs have failed (and everything that the word entails, the hopes of a patient and their family crushed over and over), the mere thought of having to switch to another medication and risking your health is revolting [...]. No one seems to acknowledge the stress that this causes patients."
However, it appears that the message is starting to be heard. In fact, Nova Scotia Health Minister Leo Glavine was the first to announce: "The biosimilar for Remicade is approved by Health Canada but it is not currently approved for coverage under Nova Scotia's drug plan for the treatment of Crohn's and colitis. We expect to be covering it for that purpose soon, but patients currently on Remicade will not be forced to switch to the biosimilar at that time."
Let's hope that this respect for patients will spread and that all provincial health ministers will follow suit. Patients say: Thank you!