While the first ustekinumab biosimilar, Wezlana, was approved in October 2023, a settlement with Johnson & Johnson (J&J) will keep it off the market until 2025, preventing competition, and causing purchasers to pay substantially more for the agent.
In approximately 1 year, Wezlana, the first ustekinumab (Stelara) biosimilar will launch in the United States, which represents more than a year delay from the time the biosimilar was approved.
CareFirst BlueCross BlueShield, based in Maryland, has filed a lawsuit in the US District Court for the Eastern District of Virginia against Johnson & Johnson (J&J) for delaying the entry of biosimilar competition to Stelara.
The law firm Lowey Dannenberg is representing the insurer in CareFirst of Md, Inc et al v Johnson & Johnson et al, which alleges J&J’s “scheme” to delay competition from biosimilars has given the company a monopoly in a lucrative market “beyond the date of [Stelara’s] legitimate patent exclusivity.”
The lawsuit alleges J&J defrauded the US Patent and Trademark Office by filing claims to gain an exclusive patent for ulcerative colitis, which was used to delay companies from launching biosimilar versions of Stelara.
“If successful, this class action will break J&J’s unlawful monopoly and enable payors and consumers to obtain affordable medication for plaque psoriasis and psoriatic arthritis,” according to the law firm.
As a result of J&J’s tactics, purchasers of ustekinumab pay pricing above what would be sustained in a competitive market, alleges the lawsuit.
“U.S. purchasers of ustekinumab are paying substantially more for the drug than they would if J&J had not engaged in the scheme,” the plaintiffs claim. “During the period of expected delay and impairment of generic competition—September 2023 through early 2025—the overpayments are estimated to exceed $1 billion.”
Stelara is approved to treat adults with moderately to severely active Crohn's disease or moderately to severely active ulcerative colitis, as well as adults and children aged 6 years and older with moderate to severe plaque psoriasis or active psoriatic arthritis. There have been infliximab (Remicade; J&J) biosimilars on the US market since July 2017 that treat these diseases, and in 2023, 8 adalimumab (Humira; AbbVie) biosimilars to treat these conditions also launched.
In 2022, Stelara brought in nearly $6.4 billion in sales in the United States, alone, and nearly $10 billion worldwide, according to J&J’s financial report, which also acknowledged that “the expiration of this product patent or loss of market exclusivity will result in a reduction in sales.”
In recognition of the extensive costs, CMS included Stelara on its list of 10 drugs subject to Medicare price negotiation under the Inflation Reduction Act. However, negotiations between Medicare Part D and pharmaceutical companies will continue to take place in 2024, and negotiated prices won’t take effect until 2026, a full year after the first ustekinumab biosimilar launches. Theoretically, the launch of competition from biosimilars will start to drive the cost of Stelara down, which has been seen with other drugs subject to biosimilar competition, particularly in the oncology space.
Although the biosimilar Wezlana was approved at the end of October, it won’t hit the US market until 2025 due to a settlement with J&J. Wezlana was also approved with the interchangeability designation.
In addition, J&J has reached settlements with Alvotech, delaying its biosimilar until February 21, 2023, although it recently received a complete response letter from the FDA; Samsung Bioepis, which cannot launch a biosimilar until February 22, 2025; and Fresenius Kabi, which agreed to launch its product no later than April 15, 2025.
These settlements can also be known as “pay for delay” since the maker of the originator product offers patent settlements paying the generic companies to not bring lower-cost alternatives to the market.
These sorts of settlements are not uncommon. Adalimumab biosimilars were kept off the US market for years after the first approvals. Amjevita (adalimumab-atto) was first approved in 2016, but a settlement kept it off the market, and allowed Humira to maintain its exclusivity until the beginning of 2023. In addition, settlements with the other makes of adalimumab biosimilars gave Amjevita 6 months on the market without other biosimilar competition. As a result, 7 additional biosimilars didn’t launch until July 2023.
[This article was originally published by our sister brand, AJMC.]