Last month, the FDA announced their approval of Amjevita, a biosimilar to AbbVie’s Humira. Humira posted global sales exceeding $14 billion in 2015, and its patents are set to expire in December, 2016.
The product, formerly known as ABP-501, received approval for the multitude of indications which are also on the Humira label, such as psoriatic arthritis, rheumatoid arthritis, Crohn’s disease, and others.
What we find interesting is the clinical data package submitted in support of this approval:
-
Three PK similarity, safety, and immunogenicity studies in 203 health subjects
-
Phase III studies in 350 patients with psoriatic arthritis
-
Phase III studies in 526 patients with rheumatoid arthritis
Even with all of this data, the FDA makes it clear that “It has been approved as a biosimilar, not as an interchangeable product.”
This is the third biosimilar approved by the US FDA in 2016, following the approvals of biosimilars for infliximab (Hospira/Pfizer, approved April, 2016) and etanercept (Sandoz, approved August, 2016).
Analysts project infliximab biosimilar to exceed $200 MM in sales in the US alone, while sales of etanercept biosimilar are expected to approach $100 MM in the US.
The questions will now center on physician/KOL usage of these products over time, as well as payer enthusiasm.
For the latter, assuming a 10-20% discount relative to the branded versions, it is probable that this is welcome news for the payers.
Physicians, we suspect, will be more conservative in their approach, especially in the absence of data demonstrating that patients established on the branded version can be safely switched over to the generic.
It will also be interesting to see if physicians essentially base their decisions on the clinical data. In other words, will they prescribe Amjevita for psoriatic arthritis and rheumatoid arthritis, but not for Crohn’s Disease or ulcerative colitis?
It bears repeating that the market for adalimumab exceeds $14 billion. Adalimumab products already approved (or nearly approved) in the EU, India, Japan, South Korea, and other countries. Additional adalimumab biogenerics are in late-stage development in the US, and certainly in these other markets.
So we feel comfortable is saying that we have the beginnings of a US biosimilars market in 2016. We have multiple products in the category, and (eventually) multiple companies launching their own products within each individual molecule/market.
But it is also clear that this is a market segment that will only be for multinational companies like Amgen and Sandoz, with the resources to develop complex protein products via multiple Phase II and III clinical trials. This, in turn, will mean that price discounts relative to the innovator products will be modest for the foreseeable future.