Radar on Specialty Pharmacy

One manufacturer recently revealed that it would launch its biosimilar of AbbVie Inc.’s Humira (adalimumab) at a huge discount not seen before in the U.S. While it almost certainly will be able to get some uptake in a market that’s about to become highly competitive, commercial payers who favor high list price/high rebate therapies are likely to not cover the agent, say industry experts.

On June 1, Coherus BioSciences, Inc. revealed that it would launch Yusimry (adalimumab-aqvh) in July with a list price of $995 per carton — an 85% discount off reference drug Humira’s (adalimumab) $6,922 price tag. The tumor necrosis factor (TNF) inhibitor, first approved Dec. 17, 2021, is a low concentration, citrate-free version of Humira, and it has approval for most of the reference drug’s indications: (1) adults with moderately to severely active rheumatoid arthritis, (2) people at least 2 years old with moderately to severely active juvenile idiopathic arthritis, (3) adults with active psoriatic arthritis, (4) adults with active ankylosing spondylitis, (5) people at least 6 years old with moderately to severely active Crohn’s disease, (6) adults with moderately to severely active ulcerative colitis, (7) adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate, and (8) adults with moderate to severe hidradenitis suppurativa.

The FDA has so far approved nine biosimilars of AbbVie Inc.’s Humira (adalimumab), and all of them — as well as some others in the pipeline — have settled patent litigation with AbbVie that allows them to launch onto the U.S. markets by a certain date.

But it’s not just the launch dates that are different. Some are low-concentration versions of Humira, while some are high-concentration versions, the latter of which has about 85% of current Humira prescribing. The FDA approved a high-concentration, citrate-free version of Humira in November 2015, but AbbVie waited until July 2018 to launch it. This formulation requires half the volume of drug injected compared with the original formulation, and it has fewer excipients that often cause discomfort when injected, as well as a thinner needle.

The FDA recently approved an expanded patient population for Novo Nordisk’s Sogroya (somapacitan-beco), a long-acting growth hormone requiring weekly administration, as opposed to daily administration of short-acting agents. Payers and endocrinologists have expressed a willingness to manage and prescribe the new agents, according to Zitter Insights. Nevertheless, this is a class where agents have not shown clinical differentiation, so payer coverage of the agents likely will come down to cost, industry experts say.

On April 28, the FDA expanded the patient population for Sogroya to include the treatment of people at least 2 1/2 years old who have growth failure due to inadequate secretion of endogenous growth hormone. The agency initially approved the drug on Aug. 28, 2020, for the replacement of growth hormone in adults with growth hormone deficiency. With the newest approval, the injectable becomes the first and only once-weekly growth hormone treatment for both children and adults.