Eye on Pharma: Fresh Biosimilar Lawsuits; FDA to Review Ustekinumab, Denosumab Biosimilars

As Regeneron gears up for a legal battle with biosimilar competitors for its reference aflibercept, CareFirst files a lawsuit against Johnson & Johnson (J&J) for restricting biosimilar ustekinumab competition, and Celltrion and Accord BioPharma file with the FDA to approve their respective biosimilar candidates.

New Lawsuits Regarding Biosimilars

Regeneron Pharmaceuticals filed a lawsuit against Samsung Bioepis over the development of the latter’s aflibercept biosimilar candidate. The biosimilar references Regeneron’s Eylea, an anti–vascular endothelial growth factor agent used to treat neovascular age-related macular degeneration.

The lawsuit claims that Samsung Bioepis infringed 51 of Regeneron’s patents related to Eylea, as described in the 83-page complaint. Regeneron chose to file the suit in a West Virginia federal court, the same court that presided over Regeneron’s previous legal battle with Viatris, also over the development of an aflibercept biosimilar. The Viatris suit resulted in the judge ruling in favor of Regeneron, saying that Viatris infringed 1 patent that isn’t set to expire until June 2027.

Reference biologic manufacturers have a long history of suing biosimilar manufacturers over patent disputes, presumably to delay biosimilar competitors from entering the market. This tactic has been seen in the adalimumab (Humira) space, delaying competition until 2023, and ustekinumab (Stelara) space, where 2 lawsuits have resulted in market delays until 2025.

However, in the instance of ustekinumab, CareFirst BlueCross BlueShield filed a lawsuit against the reference manufacturer J&J, alleging that the company is “scheming” to delay competition, creating a monopoly in a profitable market “beyond the date of [Stelara’s] legitimate patent exclusivity.”

The law firm managing CareFirst’s case argued that without biosimilar competition, health care purchases for ustekinumab must pay pricing above what would be sustained in a competitive market.

If CareFirst comes out on top, the class action will break J&J’s ustekinumab monopoly and enable payers and consumers to obtain biosimilar versions of Stelara for plaque psoriasis and psoriatic arthritis.

FDA Accepts Applications for 2 Biosimilars

The FDA has accepted 2 biologics license applications (BLAs) for biosimilars, including 1 ustekinumab product and 1 denosumab candidate.

Celltrion announced that its application for CT-P41, a proposed biosimilar to Amgen’s Prolia/Xgeva (denosumab), was also accepted for review, as reported by MarketScreener. If approved, the product would be used to treat osteoporosis, as well as prevent bone fractures in patients with bone-related cancers at high risk of fracture. Another BLA for Sandoz’ denosumab biosimilar is also under review.

Accord Biopharma also submitted a BLA for an ustekinumab biosimilar (DMB-3115). If approved, DMB-3115 will be used to treat plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis.

In the US, reference ustekinumab (Stelara) accumulated $13.9 billion in sales in 2022 and is one of the top-selling biologics in the world.

"The ability of DMB-3115's reference product, Stelara, to treat autoimmune diseases is well established and we're excited to take this important step toward providing patients a more accessible avenue to treatment for conditions that present such a significant disease burden," said Chrys Kokino, US president of Accord. "Our mission to go beyond the biology of medicine includes seeking to ease the financial burden for patients and the US health care system by providing medicines that may be more affordable, such as biosimilars."

In 2013, the joint development for DMB-3115 was undertaken by Dong-A Socio Holdings and Meiji Seika Pharma, with exclusive commercialization rights granted to Intas Pharmaceuticals through a partnership announced in 2021. Accord Biopharma is a global subsidiary of Intas Pharmaceuticals and it will be responsible for commercialization of the biosimilar in the US.