Sealed Preliminary Injunction Halts Simponi Biosimilar Launch in D. Del.

In a sealed opinion issued September 30, 2026 in Case No. 1:26-cv-00222 (D. Del.), the court granted Janssen's motion for a preliminary injunction against the commercial launch of Accord and Bio-Thera's Simponi / Simponi Aria interchangeable biosimilars, Immgolis and Immgolis Intri. Because the opinion is sealed, the reasoning, the patent(s) construed or invalidated, and the scope of the injunction are not publicly available, and the ruling's practical significance should be assessed with caution until an unsealed version issues or the parties describe the holding.

Why it matters: preliminary injunctions in biosimilar litigation routinely reshuffle launch sequencing, at-risk launch costs, payer contracting, and settlement leverage across an entire biosimilar field, and the affected product competes in a crowded TNF-inhibitor market. A granted PI narrows the runway for challengers and signals that at least one court will entertain blocking relief on this biologic at the launch stage rather than after trial-level proceedings.

Practical next steps for counsel: confirm whether the injunction runs to the full launch or only to particular presentations, whether any at-risk launch has already occurred, whether an appeal or stay motion is pending, and whether related patent challenges in other district courts remain unaffected. Watch for an unsealed opinion and any exclusivity implications in subsequent coverage.