Widespread biosimilar competition at the 30,000-foot level is not without practical complications on the ground. I gained this broader recognition by listening to people who know far more than I do about both biosimilars and its effects on the supply chain.
Last week, I was ecstatic to take my first live business trip since the beginning of the pandemic, attending the World Biosimilar Congress, hosted by Festival of Biologics USA 2022 in San Diego. In the next couple of posts, I’ll be reporting some key learnings from the sessions and attendees.
The upcoming adalimumab biosimilar launches dominated much of both the sessions and the side conversations. We recognize that this is the moment of truth for all stakeholders—manufacturers, payers, policy makers, and patients. Powerful competitive effects have been seen in the other biosimilar drug categories, and although expectations for adalimumab drug pricing do vary, all agree the prices will (1) stop rising and (2) drop substantially, with a wide range of guesses by how much.
The infusion of competition into the adalimumab category will pretty much guarantee one concern will be true—the need for health systems and specialty pharmacies in particular—to stock virtually all brands, reference and biosimilars. The reason is simple: Different insurers will cover a range of products.
This is complicated a bit by the fact that these biologics have a limited shelf-life. The reference product Humira® may be stored at room temperature for up to 14 days (far longer if refrigerated). Wastage could be a significant problem if ordering and stocking are not carefully managed.
Even if adalimumab works well for an individual patient, it may not do so indefinitely; its efficacy wanes, with little predictability. For example, this may occur after 9 months in some patients, 24 months in others. The need for dose escalation to maintain efficacy in patients taking infliximab, adalimumab, and etanercept has been seen for decades. In other words, one cannot count on a patient taking that medication for years to come. If a patient experiences reduced efficacy on a reference anti-TNF inhibitor, there is little reason to suggest that its biosimilar would then be more effective. Once this effect occurs, patients may benefit more from a move to another biologic agent (perhaps in a different class).
It certainly would seem less complex an undertaking to stock the reference agent Humira and two biosimilars. Although this will be practical in June 2023, it will not suffice by December, when perhaps eight biosimilars will have launched. Health systems and doctors’ offices will be reluctant to stock nine brands of the same drug. This puts more pressure on specialty distributors and specialty pharmacies to comprehensively stock adalimumab biosimilars and deliver timely doses of the covered product. After initializing treatment at the provider’s office or facility, most patients will be asked to self-administer (i.e., receive adalimumab through specialty pharmacy channels).
Of course, if insurers and pharmacy benefit managers decide to sharply restrict the number of biosimilars covered, this would limit some concern, but the distributors don’t seem too worried. The systems to identify and deliver the correct biosimilar are in place. Let’s see how well it works.