Johnson & Johnson’s Janssen has, for now, kept the first biosimilar copies of its arthritis and colitis drug Simponi off the US market. On 30 September a federal court in Delaware granted Janssen a preliminary injunction against Accord BioPharma and its Chinese development partner Bio-Thera Solutions.
The order bars the two companies from making or using their golimumab biosimilar, coded BAT2506, in commercial quantities, from offering or selling it in the US and from importing it for sale. Janssen must post a bond of $98.8m to cover the defendants’ losses if the injunction later proves unjustified. The accompanying opinion was filed under seal pending redaction, so the court’s reasoning is not yet public.
An approved product held back
The ruling lands on a product regulators have already cleared. The FDA approved Accord’s Immgolis and Immgolis Intri on 15 May as the first interchangeable biosimilars to Simponi and Simponi Aria, the subcutaneous and intravenous forms of golimumab. Bio-Thera handles manufacturing and supply, while Accord holds exclusive US commercial rights and had planned a launch in the fourth quarter of 2026.
Janssen filed its suit under the biosimilars statute on 3 March, asserting 17 patents, and moved for the injunction on 6 May. A hearing on the motion was scheduled for 1 September, according to the law firm Goodwin’s Big Molecule Watch blog.
The case shows how layers of overlapping patents can delay a biosimilar long after the FDA has said yes.
A second front at the patent office
The challengers are fighting back outside the courtroom. Accord, its parent Intas and Bio-Thera asked the US Patent and Trademark Office to review four Janssen golimumab method-of-treatment patents, and the office instituted those reviews on 9 September.
Janssen is also pursuing a second golimumab rival. On 19 June it sued Alvotech in the Eastern District of Virginia over the AVT05 biosimilar, asserting 14 manufacturing-related patents and seeking to stop Alvotech and its US partner Teva from commercialising the product.
What to watch
- Publication of the redacted opinion and any appeal by Accord and Bio-Thera.
- Outcomes of the four patent-office reviews, which could weaken Janssen’s position.
- Progress of the Alvotech case and whether Janssen seeks a similar injunction there.
