In This the Year for a Star Turn by Stelara Biosimilars?

Biosimilar watchers circled 2023 as a red-letter year because that was the year that the Humira (adalimumab) biosimilars were scheduled to come on the market. The roll out started with Amgen’s Amjevita (adalimumab-atto), which hit the market in launched in Janaury 2023, and was followed by eight others that year and then a tenth, Simlandi (adalimumab-ryvk), in May 2024.

This year the biosimilars to Stelara (ustekinumab) stand to be the stars of the biosimilars show. The FDA has approved seven Stelara biosimilars, and Amgen was positioned to make its Wezlana (ustekinumab-auub) to be the first one to launch. So far, though, the Thousand, Oaks, California, biotech company hasn’t made any announcements.

The other six FDA-approved Stelara biosimilars include Selarsdi (ustekinumab-aekn), Pyzchiva (ustekinumab-ttwe), Otulfi (ustekinumab-aauz), Imuldosa (ustekinumab-srlf), Yesintek (ustekinumab-kfce) and Steqeyma (ustekinumab-stba).

Humira, an injectable treatment for rheumatoid arthritis and several other autoimmune conditions, has been a blockbuster drug — informally defined as annual sales of $1 billion — for years. The advent of Humira biosimilars was seen as important partly because it was seen as the beginning of price-lowering competition with Humira.

Stelara, which is also an injectable treatment for autoimmune conditions but not for rheumatoid arthritis, is also a blockbuster drug although its peak annual sales have been about half the size of Humira’s. Still, the potential savings for payers could be large if Stelara’s biosimilar bring down prices.

With Humira, the biosimilars sales were disappointing in 2023 but picked up in 2024 as the large pharmacy benefit managers started taking Humira off some if their formularies and replacing the familiar brand-name drug with biosimilars. CVS Caremark started in April 2024, and Optum Rx and Express Scripts followed suit. Still, AbbVie has hung to market share for its prize drug, Humira, by discounting the price rebates.

One of the question about Stelara is whether it’s maker, Johnson & Johnson, will pursue the same strategy to fend off biosimilar competition.

A complicating factor in the market for Stelara and its biosimilars is that Stelara was among the first 10 drugs selected for CMS price negotiation under the Inflation Reduction Act (IRA). Presuming the negotiated price goes into effect in 2026 as scheduled, the Medicare price will be $4,695, or roughly 66% less than 2023 list price. That lower price, even if it doesn't go into effect for several years, may make it more difficult for Stelara biosimilars to compete with the brand-name drug as the calling card of any biosimilars is its lower price with relative to its brand-name reference drug.