Biosimilars & Patient Notification

There’s an issue quietly taking place in state legislatures all across the country. You may not have heard much about it – but if you are a patient living with rheumatoid arthritis it is an issue that will be very likely to affect you in the not too distant future.

Many of us living with RA (and other chronic illnesses) currently rely on biologic medications to function in our day-to-day lives. The most advanced forms of RA treatment, biologic medications have very unique, complex molecular structures that are made from living cells. These molecular structures are not easily replicated, which means that it isn’t really possible to create an exact “generic” version of a biologic medication. In fact, that’s one of the reasons these medications tend to be so expensive.

But right now scientists and pharmaceutical companies are working to develop biosimilar versions of many biologic medications. While these biosimilars won’t be exactly the same, eventually the Food and Drug Administration (FDA) may decide that some of these biosimilars should be considered “interchangeable” with the biologic medications they mimic. In fact, last month an FDA advisory committee voted to recommend that the government approve its first biosimilar application. So it is only a matter of time until these biosimilars come to the market.

Biosimilars have amazing potential. They give patients like me hope, because if I happen to run out of options for traditional biologic medications I may be able to turn to biosimilars once they are approved. Biosimilars also have the potential to be much more affordable than biologics, and as someone who has struggled to afford my biologic medications I would love to see a treatment option with a lower price tag!

However, even the slightest difference between biosimilars and the biologics they mimic – whether in the manufacturing or even the handling process – could have significant health impacts on patients. And without a law requiring notification, pharmacies could potentially substitute biosimilars for biologics without notifying patients or their doctors. That’s right – your doctor could write you a prescription for a biologic and the pharmacy could instead give you a biosimilar without even telling you.

Whether or not pharmacists will be required to notify patients about substitution will vary from state. Colorado, for example, is currently working to pass a bill that would require pharmacists to notify patients and doctors if a biosimilar is substituted. A few weeks ago I was given the opportunity to testify on this issue in front of the Colorado Senate Health & Human Services Committee.

In my testimony, I told the Committee about my most recent pregnancy, during which my RA flared so badly that I could barely get out of bed – let alone take care of my first child. My rheumatologist, OB, and pediatrician decided together that the best course of action was for me to re-start my biologic medication during my third trimester. The data showing that this would be relatively safe for my unborn son was extremely limited, which made it a very difficult decision. But, after agonizing over this decision, what if the pharmacy had substituted a biosimilar for the biologic my doctor had prescribed without my knowledge? And without my doctors knowledge? Without notification the substitution could have put me and my unborn son at risk.

I also explained to the Committee that the biologic I have been taking for years has recently stopped working. This means that I am in the process of switching to a new biologic – the third since my diagnosis. But what if I experience an adverse reaction from my new medication? How am I supposed to adequately manage my disease – and consequently live my life – if I don’t even know what drugs I am actually receiving when I go to the pharmacy? Notification is vital to establish an accurate and transparent medical record so that my doctor and I can have the information we need to make these complicated decisions.

After my testimony and that of others, the Colorado Senate eventually decided to pass the bill requiring notification of biosimilar substitutions. The bill is now waiting for a hearing date in the House – and when the hearing is scheduled I hope to be able to testify again. Similar bills are currently being proposed in other states – and if they aren’t they should be! As patients we need to speak up to promote legislation that puts transparency and patient safety first.

(If you are interested in adding your voice to this issue, check out the Global Healthy Living Foundation and Seth’s 50 State Network to learn more!)

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This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.

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