A US court denied J&J's injunction against Samsung Bioepis, clearing Pyzchiva's launch. However, Regeneron's win against Samsung/Formycon set a precedent allowing patent suits against foreign biosimilar makers, raising legal risks for global firms in the contentious US biologicals market.
In April 2025 in the US, it was announced that Johnson & Johnson’s (J&J) request for an injunction against Samsung Bioepis to prohibit sales of Pyzchiva (ustekinumab-ttwe), a biosimilar of J&J’s Stelara, under Pharmacy Benefit Manager (PBM) subsidiary brands, had been rejected. This decision now allows Samsung Bioepis to launch private label products of Pyzchiva in the US. By contrast, in January 2025, Samsung Bioepis and other non-US firms were held back from commercializing biosimilar products due to patent infringement against US firms.
J&J filed for the injunction in February 2025, claiming that it did not grant Samsung Bioepis the authority to launch private label products in their Stelara biosimilar agreement. In general, private label products are sold under PBM subsidiary brands rather than pharmaceutical company brands and are relatively cheaper due to fewer intermediate distribution stages. As a result of this, such products threaten to rapidly reduce J&J’s market share.
Ustekinumab is a humanized monoclonal antibody that interferes with the triggering of the body’s inflammatory response through the suppression of certain cytokines. Specifically, it blocks interleukin IL 12 and IL 23 which help activate certain T cells. It binds to the p 40 subunit of both IL 12 and IL 23 so that they subsequently cannot bind to their receptors. It is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis [1].
Despite this win for Samsung Bioepis, the Federal Circuit appellate court found that US companies can sue foreign rivals, despite limited business operations in the country.
Here, alleging patent infringement, Regeneron sued companies, including Samsung Bioepis and Formycon, that had filed abbreviated biologics license applications (aBLAs) with the US Food and Drug Administration (FDA) seeking approval for their aflibercept biosimilar products under the Biologics Price Competition and Innovation Act (BPCIA). Regeneron holds the BLA of the originator, Eylea (aflibercept).
The US Northern District of West Virginia issued a preliminary injunction barring Samsung and Formycon from commercializing the products described in their aBLAs. Samsung and Formycon objected, citing that they could not be subject to a suit in the US. However, the court found it was enough that they had filed aBLAs, with intent for the products to be marketed in the US/West Virginia at some point.
Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor. It is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy in patients with diabetic macular oedema [2].
Samsung is based in South Korea and Formycon in Germany, and neither have facilities or employees in West Virginia or the US. Neither company has plans to directly sell the product in the US, the products would be sold through US partners. However, with the aBLA, service of Notice of Commercial Marketing, and partnering with US companies to manufacture, package and label its product, in both cases this was deemed sufficient as ‘minimum contacts’ for the foreign firms to be brought to court in West Virginia. It is thought that decisions such as this may dissuade drug developers from targeting the US market in the future.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jul 30]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of aflibercept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jul 30]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-aflibercept
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