Coherus BioSciences Disrupts Humira-Referenced Biosimilar Space

In July, Coherus BioSciences will launch its Humira-referenced biosimilar, Yusimry in the U.S. at an 85% discount from the originator, Humira (adalimumab). It is very likely that Yusimry (adalimumab-aqvh) will have the lowest list price among the seven Humira-referenced biosimilars that will hit the U.S. market by the end of this year.

Mark Cuban’s Cost Plus Drug company will include Yusimry in its list of products that individuals can purchase directly at discounted prices.

In 2021, the Food and Drug Administration (FDA) approved Yusimry. It is a tumor necrosis factor blocker, which is indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis, and to treat Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa. Though not granted a therapeutically interchangeable designation from the FDA, as a biosimilar Yusimry and its reference product, Humira, have no clinically meaningful differences in terms of safety or efficacy. Like Humira, Yusimry includes an autoinjector as well as a citrate-free formulation.

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Coherus BioSciences is no stranger to biosimilars. The company has a track record in biosimilar manufacturing and supply chain management. Last year, Coherus BioSciences launched the only biosimilar product that is therapeutically interchangeable with Lucentis (insulin glargine) across all five indications.

As Yusimry will launch at a price of $569 plus dispensing and shipping fees, it will still be a lot of money for most people. How much of an impact Yusimry’s availability will have on affordable patient access will depend on multiple factors. Uninsured patients will likely benefit the most from such a sharply discounted product. For insured individuals, however, cost savings will depend on how well they are covered for the originator product, Humira, and whether they’ve taken advantage of AbbVie’s patient assistance program which helps defray out-of-pocket costs.

Some who are insured – whether in Medicare or the commercial sector – may face lower co-payments for the originator product, Humira, than the cost of a Yusimry prescription. Commercially insured individuals, in particular, may not necessarily stand to gain financially from purchasing Yusimry directly from the Cost Plus Drug Company, if they make use of AbbVie’s patient assistance program aimed at reducing out-of-pocket costs for the originator, Humira. Those with only an adalimumab-based product as their only prescription drug in a given year would probably do better just to take what the manufacturer offers in terms of co-payment defrayment. This doesn’t have to be from AbbVie. It could also apply to other biosimilar manufacturers who will enter the market later this year, and may provide financial assistance to patients.

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But for those on multiple prescriptions, purchasing Yusimry directly from the Cost Plus Drug Company rather than accepting a manufacturer’s financial patient assistance program may make more sense. And this has to do with a tool pharmacy benefit managers (PBMs) invented and gave the euphemistic sounding name, co-pay accumulator program. In the context of a co-pay accumulator program, a manufacturer’s monetary assistance to patients to decrease their out-of-pocket costs (or co-payments) does not count toward the patient’s deductible and out-of-pocket maximum. PBMs employ co-pay accumulator programs as ways to blunt the impact of drug manufacturers’ patient assistance programs.

Patients who are subject to co-pay accumulator (or maximizer) programs, and are on multiple prescriptions which cause them to inevitably reach their deductible, will want the plan’s coverage to kick in at that point. And so, they may opt for Yusimry. In essence, the low wholesale acquisition cost price for Yusimry reduces the value of co-pay accumulator programs to PBMs.

Perhaps more importantly, the lower net price of Yusimry can also benefit self-employed insurance plans as it will enable them to achieve direct cost savings, analogously to what it does across Europe for government and private payers. The 85% discount in list price is roughly what’s been observed for Humira and Humira-referenced biosimilars that have been on the market in Europe for several years. In turn, this has translated into much lower net prices of all adalimumab products across Europe.

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In the U.S., Yusimry’s steep discount could have a knock-on effect, causing disruption across the entire class of other Humira-referenced biosimilars that are poised to launch later this year. Besides Yusimry, at least another five will enter the market at some point in 2023.

To some degree, these other biosimilars will have to compete with Yusimry on price. Though, as we’ve seen in the recent past, the U.S. biosimilar market is replete with examples of distorted financial incentives which can work to the disadvantage of those manufacturers who seek to use lower prices as a lever. For a variety of reasons, in spite of substantially lower list prices, biosimilar traction in the U.S. has been slow, especially around the time of the initial rollout of biosimilars in a particular class. This applies to multiple classes of biologics, including the monoclonal antibody, adalimumab.

In January, for example, Amgen launched Amjevita as the first Humira-referenced biosimilar. Notably, Amgen deployed two price tiers. One tier constitutes a mere 5% discount relative to Humira’s monthly list price of $6,922. The other is about half the price. However, thus far the lower-priced version of Amjevita has generally not been granted favorable formulary placement by PBMs.

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Undoubtedly, Coherus BioSciences and Mark Cuban’s Cost Plus Drug Company will shake up the Humira and Humira-referenced biosimilar space with the launch of Yusimry at a 85% discount. However, the extent to which disruption takes place will depend on some of the peculiar vagaries of the U.S. insurer and PBM market.