Biosimilars: Unanswered Questions

Stephen Paget, MD


August 07, 2015

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This is Dr Stephen Paget. I'm the physician-in-chief emeritus at Hospital for Special Surgery in the Division of Rheumatology.

I would like to talk to you today about biosimilars. Now, other doctors have discussed this with you, but I want to discuss some practical points. In Europe, the "powers" that pay for these medications, I believe, will allow you to continue an anti–tumor necrosis factor (TNF) agent if it is effective. However, if you are starting a new anti-TNF, you have to start one of the cheaper medications (eg, conventional disease-modifying antirheumatic drugs [DMARDs]) or what are called biosimilars.

The RAND Corporation has reported that within the next 10 years, we will save $1 trillion with biosimilars, which are usually 30% lower in cost. I think it is important if you have a similar medicine to be able to use that. However, the question that comes up is, will insurance companies mandate a switch? If you are mandated to switch, will that medicine, however similar chemically, be the right medicine for your patient? Or will it lose effectiveness? I think these are all very important questions.

There is no doubt that in head-to-head studies comparing the biologic agents we now use with biosimilars, the biosimilars do quite well from a clinical point of view. But the fact is that they are probably not exactly the same drug. The fact is that the glycosylation and other factors may be different. The immune system may see the construct in a different manner and form antibodies to one where they may not form antibodies to another.

I think we have to get these answers. I'm all for less expensive medications, certainly, for both patients and society, but these are important things to think about. Thank you.


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