We are heading down the stretch for the most lucrative biosimilar market that may ever open in the US healthcare system. On January 31, Amgen will launch its long-awaited biosimilar Amjevita®.
The opening of the long-delayed competition for adalimumab marks the latest and most important era in the biosimilar timeline. Personally, I’ve been writing about this day for more than 6 years. I wonder if DraftKings® will be taking wagers on this race?
There are a few things we do know about how the market will open up, and there are quite a few things we still don’t know for sure. For instance, we know that AbbVie will not cede its $20 billion in US sales to biosimilar competitors. The patent thicket that AbbVie erected for Humira® is testament to its willingness to defend a product that is well past market exclusivity and principal patent expiration. To the extent that AbbVie increases Humira rebates and lowers its retail price will define just how aggressive it intends to be to retain the dominant market share. Whether or not AbbVie follows this path, payers will see big savings from the adalimumab biosimilar launches. I’m betting the payers will be the big winners.
Based on the reporting of the last few weeks, we do know that the PBMs will (1) retain Humira as a parity product in 2023 and (2) be open to add one or more biosimilars to their formularies at parity with the reference product. Based on payer market research and in speaking with individual payer executives, we know health plans, insurers, and perhaps even employer sponsors will utilize the 2023 adalimumab biosimilar launches to set themselves up for 2024 and an intentional movement away from Humira’s market dominance.
In order for that to happen, the biosimilar manufacturers must meet payers’ expectations. That is, they must:
- Engage in meaningful negotiations for significant savings over the reference brand
- Come to the table with patient assistance services that approximates what AbbVie has established
- Make a convincing argument (with or without an interchangeability designation) that use of their biosimilar will result in minimal or no provider or patient treatment disruption
This last bullet is particularly important, because it infers a number of different issues, including ensuring the supply chain and offering enough of the important characteristics of Humira that patients don’t bother their doctors for a return to the innovator brand.
Let’s unpack these for a moment. In regard to the supply chain, does the biosimilar manufacturer have enough backlog to handle greater-than-anticipated utilization? Can its manufacturing facility handle new output (and does it have a history of doing so)? This may be a consideration for Alvotech (which is still awaiting US approval) or Fresenius Kabi, or perhaps even a couple of the more established biosimilar makers.
The other consideration may be more nuanced. Aside from the question of citrate-free or not citrate-free (which the biosimilars are overwhelmingly the former), what of the various injection devices that will be used for each of the new biosimilars? Will patients notice a transition to a new product? Will they be comfortable with the new pen-delivery device, finding it easy to use or not be happy with a different needle size?
Over the years writing about adalimumab development, I have paid little consideration to self-injection devices. An interchangeable biosimilar does not imply that the delivery device is the same, only that the agent can be automatically substituted for the reference product. It will be very interesting to see how this plays out in July, with the launch of most other adalimumab biosimilars.
In the meantime, Amgen will launch Amjevita with a couple of limitations: It will be available in the low-dose concentration only, in a citrate-free version, without interchangeability. The high-dose concentration and interchangeability designation may come in 2024. How limiting are these characteristics? From what we hear, not very. It’s time to see what the market actually does, based on Amgen’s pricing.