First Adalimumab Biosimilar, Adalimumab-atto, Available in the US

The first adalimumab (Humira; AbbVie) biosimilar, adalimumab-atto (Amjevita; Amgen) is now available in the US. Adalimumab-atto was the first adalimumab biosimilar approved by the US Food and Drug Administration (FDA) in 2016. Adalimumab is an injectable tumor necrosis factor (TNF) blocker and is approved to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, uveitis, ulcerative colitis, Crohn’s disease, hidradenitis suppurativa, and juvenile idiopathic arthritis.¹ The most noticeable difference between adalimumab and adalimumab-atto is that adalimumab-atto is not approved to treat hidradenitis suppurativa or uveitis.

Dermatology Times® Editorial Advisory Board members, Christopher Bunick, MD, PhD, physician-scientist and associate professor of dermatology at Yale University and dermatologist at Yale Dermatology Associates in Middlebury, Connecticut, and Raj Chovatiya, MD, PhD, assistant professor of dermatology and director of the Center for Eczema and Itch at the Northwestern University Feinberg School of Medicine in Chicago, Illinois, share their thoughts on adalimumab-atto availability in the US and what to expect in 2023 with more adalimumab biosimilars.

Transcript:

Christopher Bunick, MD, PhD: I'm really excited that Amjevita is now available in the United States for dermatologists to prescribe to patients with plaque psoriasis or psoriatic arthritis. Very important to know Amjevita is not approved for hidradenitis suppurativa. So this biosimilar we can incorporate into our psoriasis repertoire of medications.

Raj Chovatiya, MD, PhD: The entire concept of biosimilars is not a new one. It's instituted through laws actually by the federal government to really try to figure out how we can get better access and pricing when it comes to expensive targeted therapies like biologics. So really with a biosimilar there should be no clinically meaningful difference between a parent product let's say in a biosimilar.

Bunick: Now, there are some things to keep in mind. Amjevita, just like Humira, actually has a box warning for serious infections and malignancy, including lymphoma. There may be some differences in things like the concentration, the formulation, the look and feel of the syringes including the shape and weight of syringes. Now, Amjevita is going to come in an auto injector and as well as a prefilled syringe, it does require refrigeration. It is importantly citrate-free, it's actually free of all preservatives. So this is an exciting time in dermatology because over the next year, we're actually expecting many biosimilars, particularly in the adalimumab space, but in psoriasis and potentially down the road-other inflammatory disorders.

Chovatiya: Overall, the entire concept of biosimilar, it was really designed to have a drug program that would have obviously less R&D time and budget, given how long it takes oftentimes to really get a true new biologic out there, tons and tons of clinical studies, you do save on that aspects cheaper, you're able to get something to market quicker and potentially get better access and in that way, actually penetrate the market better. And as we know, the case of psoriasis is a great example. There's a lot of patients with moderate to severe disease that just really aren't adequately treated and are not on a biologic therapy. At the end of the day, biosimilars, you know, should be increasing access to what might be a life-changing medication and potentially lower overall costs to the health care system, and even potentially, the individual when it comes to sort of a lot of the back and forth that we have as well. And so I would say that that's probably the biggest pluses. In terms of the biggest minus, I think there's just a lot of unknown given that we haven't really had that much real world experience with us. And I think time is going to really help educate us all.

Bunick: But it is important to understand that biosimilars are not an exact replica of the branded medicine. And so some patients may do well or better with the branded medicine and others may do very well with the biosimilar. They're not exact copies of each other, but they're, again, similar. So I think that we can expect the safety profile to be about the same as all the other anti-TNF agents that are on the market. But we can expect, at least on part efficacy, which was seen in some of the phase three clinical trials that Amjevita underwent, when the FDA approves a biosimilar, there is in fact a very rigorous evaluation process, from the clinical data, the safety data, all the way to the research and the science of how it behaves, and all the behind-the-scenes research data. That's important for understanding a product that's coming to market. So, there is quite a bit of legwork that's gone into understanding biosimilars. And I think today's an exciting day. We now have this biosimilar available for our patients. And I think that over the coming weeks to months, it's going to be very interesting to see how it performs in the real world experience with our psoriatic patients.

Transcript is edited for clarity.

Reference

1. FDA approves Amgen’s amjevita for the treatment of seven inflammatory diseases. Amgen. Published September 23, 2016. Accessed January 27, 2023. https://www.amgen.com/newsroom/press-releases/2016/09/fda-approves-amgens-amjevita-adalimumabatto-for-treatment-of-seven-inflammatory-diseases