A US court has blocked the launch of the first biosimilars to J&J’s Simponi, delaying cheaper golimumab for US patients while a patent fight continues.
On 30 September, the US District Court for the District of Delaware granted Janssen, part of Johnson & Johnson, a preliminary injunction against Accord BioPharma and Bio-Thera Solutions. The ruling stops the companies from launching their golimumab biosimilars, which the FDA approved in May.
The ruling at a glance
- Reference products: Simponi and Simponi Aria (golimumab)
- Biosimilars blocked: Immgolis and Immgolis Intri (BAT2506), from Accord BioPharma and Bio-Thera Solutions
- Court: US District Court for the District of Delaware
- Bond: Janssen must post a $98.8m bond
- Appeal: Accord and Bio-Thera filed a notice of appeal on 1 October
Why it is a landmark
Janssen is reported to be the first company to win a preliminary injunction against a biosimilar in the District of Delaware. The case involves 17 patents covering golimumab’s cell lines, manufacturing processes, compositions and some methods of treatment. The court’s full reasoning has not yet been made public.
The bond protects the biosimilar makers: if the injunction is later found to be wrong, they can claim compensation for lost sales.
What’s at stake
Simponi’s US sales exceeded $1bn in 2024. Biosimilars typically launch at lower prices and can erode a brand’s sales quickly, especially once payers and pharmacy benefit managers switch their formularies.
Why it matters
- Delayed savings. Payers and patients will wait longer for lower-cost golimumab.
- A new tactic. Manufacturing and process patents can be powerful tools to delay biosimilars, even after FDA approval.
- More cases coming. Janssen has also sued Alvotech over its golimumab biosimilar.
What it means for the supply chain
Biosimilar makers often build up inventory ahead of an expected launch. An injunction leaves that stock waiting, adds cost and complicates production planning. Distributors, group purchasing organisations and health system buyers who planned for a lower-cost golimumab option will need to revise their forecasts until the appeal is decided.
The bottom line
The Simponi ruling keeps biosimilars off the US market for now and shows how process patents can stretch a brand’s exclusivity. Watch the appeal closely.
Frequently Asked Questions
What did the court decide? It granted Janssen a preliminary injunction blocking Accord BioPharma and Bio-Thera Solutions from launching their golimumab biosimilars in the US.
Were the biosimilars approved by the FDA? Yes, in May 2026. The injunction is a patent ruling, not a regulatory one.
Is the decision final? No. It is a preliminary injunction during the patent case, and the biosimilar makers have appealed.
How big is Simponi? Its US sales exceeded $1bn in 2024.
Sources
| Source | Used for |
|---|---|
| Pearce IP | Ruling date, court, products and appeal |
| IPFray | Landmark status, patents, bond and sales figure |
| Big Molecule Watch | Ruling coverage |
| Fierce Pharma | Bond deadline and regulatory context |
Additional Resources
| Resource | What you’ll find |
|---|---|
| US Food and Drug Administration (FDA) Purple Book | Licensed biological and biosimilar products |
| Association for Accessible Medicines (AAM) | Biosimilar savings and market data |
| US District Court for the District of Delaware | Court records |
| Johnson & Johnson investor relations | Immunology portfolio updates |
Data note: The court’s full reasoning was not public at the time of writing, so the specific patents behind the ruling are not identified.