Autoimmune disorders affect over 20% of the American population, according to a recent census. It is amazing to think that this problem is so large and that over 50 million Americans are living with autoimmune disease. My Father lives with rheumatoid arthritis and is not a rich man. He cannot afford the new and effective drugs.
The development of the drugs Humira and Enbrel has made the lives of many with rheumatoid arthritis and psoriasis so much better, but can they be more affordable for my dad?
What are Biosimilar Drugs?
I did some research on Humira and Enbrel and found they are actually complex proteins that are naturally found in the cells of the human body and they are manufactured using biotechnology. In the case of autoimmune diseases, these proteins can signal the immune system to stop attacking healthy tissue.
Since people with rheumatoid arthritis, like my father, suffer such severe pain and disability, this is really the best treatment for them. Normally, these biotechnological drugs are called “biologics” and the generics are known as “biosimilar.” The biosimilar versions are more affordable.
How Expensive are the Drugs?
These drugs, like Humira and Enbrel, are very costly. In fact, my Father was looking at an annual price tag of $50,000 just to maintain the medication. The biosimilar versions are still not available to him or anyone like they are in Europe. When the drugs go generic, on the other hand, many more people could afford them.
Then I found out that the companies making these two competing medications are simply adding new patents to slow down the availability of generic forms. One source stated this notion is purely profit motivated and it is keeping many from getting the relief they need.
Affordable Care Act
The Affordable Care Act, passed in 2010, indicates that the FDA is allowed to approve biosimilars. The original drugs, known as biologics, were shielded from any type of competition in the generic form.
According to my Dad’s doctor, the biologic drugs can be approved by the FDA, but it will have to lay down the ground rules and, new patents slow down any development into generic affordable biosimilars.
It takes time for the FDA to approve biosimilars and, it appears that Dad will have to wait until then. Meanwhile, there is concern that the makers of the biologics like Humira will continue to find loopholes.
Many pharmaceutical companies are on the side of the consumers in this issue. Currently, there are approximately 60 biosimilars that are being tested for release. 13 of these are versions of Humira. This sets the generic competition high for the biologic drugs and it means that more will be able to get the affordable biosimilars very soon.
The companies making the brand-name biotechnology drugs claim that the molecules are very complex and cannot be copied. This is why the true name for the generics is actually “biosimilars.” Really, they are the same. Brand-name companies with the biologics on the market are making biosimilars as well.