A biosimilar drug is a drug that is chemically and functionally similar to other biologic drugs that we use. For example, there are many anti–tumor necrosis factor (TNF) medications, and companies are now starting to make similar drugs in similar fashions in the test tube and are studying them. It has been shown in Europe and elsewhere that they have similar effects, both in their positive clinical effect and their side-effect profile.
The main issue is, especially in Europe, for example, what do you do with these drugs? How do you use them? It is important to appreciate the fact that biologic drugs, such as anti-TNF medications, are very expensive—between $10,000 and $30,000 a year. It has been said by the Rand Corporation that within 10 years the decreased costs with the use of biosimilars will be over $1 trillion.
However, the Europeans have dealt with this in an interesting way. They have deemed these drugs equal to the drug that it is compared to, and there are comparative studies that have shown that, both in efficacy and side-effect profile. Initially, they felt that they would demand that everyone use those drugs, including people who have previously been on the other similar drug. But now they have made a decision that those people who are doing well on the actual biologic drug, the initial one, can stay on their drug, and anyone who now starts the drug has to start with the other drug that they feel is similar in every way and much less costly.
So, biosimilars are here. They are here to stay. I think that they are very important from a financial point of view. What we don't really know about is their long-term side effects. We don't really know in the end whether they are going to be very similar, and we also don’t know whether we can interchange them. That information will come out with time, but either way, rheumatology will never be the same.
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Cite this: How Can Rheumatology Save $1 Trillion? - Medscape - Dec 11, 2014.