Brian Biehn, senior director of biosimilar commercialization at Cencora, makes predictions for how big regulatory approvals in 2023 will shape the biosimilar space going forward.
Brian Biehn, senior director of biosimilar commercialization at Cencora, formerly known as AmerisourceBergen, recaps some of the major regulatory updates for biosimilars in the United States and makes predictions for how the market will develop in the years to come.
2023 was a big year for biosimilars in the US, with the market introductions of 8 adalimumab biosimilars as well as regulatory approvals for the first biosimilar tocilizumab, nataliuzmab, and subcutaneous infliximab. How do you think these advancements will shape the biosimilar market in the coming years?
Yeah, 2023 was definitely a big year for biosimilars. As you mentioned, we continue to have really good momentum with approvals. The approvals are written into new molecules such as tocilizumab and natalizumab. The approval for natalizumab [marks] the first neurological biosimilar, which is expected to hit the market in 2024. All eyes are still on adalimumab, though, and the Humira biosimilars.
So, today we have 9 manufacturers that have [approvals and 8 launches for] biosimilars to Humira [reference adalimumab]. There are still a few in the pipeline. We do believe the success of the future market is going to be shaped by the Humira market, specifically for the pharmacy benefit space [overall] and those biosimilars to come. So they're all kind of looking at Humira and seeing how are those manufacturers going to do? How successful are they going to be? What is the adoption going to look like?
To date, we've seen slow uptake of those Humira biosimilars, but we are expecting that to become more widespread going into 2024 and 2025. We believe there's kind of a period here where [pharmacy benefit managers] and payers need to become comfortable with the Humira products; they need to put them on the formulary. Also, from a downstream perspective, customers and patients need to become more comfortable with these products. So, even though it's been a slow start for Humira [biosimilars] and that's probably the biggest thing that happened in 2023 with those [launches], we do see some upside and are expecting more adoption to occur in the coming years.
Now that ophthalmology biosimilars have been on the market for a year and both FDA-approved products now have interchangeability, what is the current status of ophthalmology biosimilars and how to do you see this changing going forward?
Ophthalmology biosimilars are doing well. We've seen month over month the adoption continues to increase. We do anticipate that this trend is going to continue as there are still more manufacturers in the pipeline, specifically for the Lucentis [ranibizumab] biosimilars, which already have the 2 biosimilars on the market.
We're also really interested to see where the Eylea [aflibercept] market goes. We're expecting, potentially in 2024, biosimilars will start to move in that market. We have some ongoing patent litigation occurring right now that could push that launch back to later, but the most optimistic right now is potentially 2024.
One of the things that we continue to talk about with ophthalmology biosimilars—we've talked about in the past and it's important to most of the biosimilar market categories, but more specifically this one—is education. We've heard that there has been confusion amongst providers and patients with these products, not being aware that they're available, being a little bit hesitant to use them because it is an injection into the eye. So, education still remains to be the largest barrier. We have seen that education gap tighten. As I've said, the adoption has increased over time, but I still think it's important for us as an industry to keep pushing that education forward and trying to combat any misinformation that's going on and drive awareness of these products.