8 Humira Biosimilars Are on the Market

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From none to one and now there eight.

Fresenius Kabi and Biocon Biologics announced yesterday that their Humira (adalimumab) biosimilars were on the market in the U.S., the last two in a surge of seven Humira biosimilars that came on the market during the first few days of July. The eighth, Amgen’s Amjevita (adalimumab-atto) got a head start and was launched in January

The Humira biosimilar dam was expected to break in July with a pack of competitors to AbbVie’s top-selling anti-inflammatory. If they live up to their reason-to-be, this group of biosimilars will stir up price competition and put downward pressure on the cost of treating rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and several other autoimmune diseases that Humira is prescribed for.

Missing so far from the parade of launch announcements is Pfizer’s Abrilada (adalimumab-afzb). Pfizer announced last year that it was pursuing an interchangeability designation for Abrilada.

In addition to Freseniuys Kabi’s Idacio (adalimumab-aacf) and Biocon Biologics’ Hulio (adalimumab-fkjp), the five other Humira’s launched in July are Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), Organon and Samsung Bioepis’ Hadlima (adalimumab-bwwd), Sandoz’s Hyrimoz (adalimumab-adaz), Celltrion Healthcare’s Yuflyma (adalimumab-aaty) and Coherus Biosimilar’s Yusimry (adalimumab-aqvh).

The list, or wholesale acquisition cost, of Humira is currently $6,922 for a four-week supply or about $83,000 annually. The biosimilar makers have adopted several different pricing strategies. For example, Amgen and Biocon Biologics have said they would sell their Humira biosimilars at two prices, one that would be a small discount relative to Humira and the other at much steeper discount. Biocon said its second price would be 85% lower than Humira’s, which works out to about $12,500 on an annual basis

Industry observers say the higher price is likely a before-rebate price for pharmacy benefit managers (PBMs), who will pay a net price that is considerably less after rebates and other discounts are factored in. The lower price may come into play for high deductible plans.

So far, Cyltezo is the only biosimilar with the interchangeable designation from the FDA. Interchangeability means that in most states the biosimilar can be substituted for Humira at the pharmacy level, although there are various requirements to notify the prescriber after the switch has been made. Boehringer Ingelheim is supplying its sales representatives with information about state pharmacy laws and interchangeability so they can inform prescribers about the interchangeability rules as part of sales effort for Cyltezo.

The PBMs, especially the three largest ones — Optum Rx, CVS Caremark and Express Scripts — will have a strong influence on the uptake of the Humira biosimilars by virtue of their formularies and the drugs they cover. Optum Rx has announced that it is putting Cyltezo, Hyrimoz and Amjevita on its formulary. CVS Caremark and Express Scripts have not made announcements about their formularies and the Humira biosimilars.