Ustekinumab’s principal patents are set to expire in September of this year, and prospective biosimilar makers are lining up to join this next immunology marketplace. However, in a patent litigation settlement announced on May 23, the launch of the biosimilars to Stelara® may have to wait a bit.
Amgen’s settlement with the reference drug maker Johnson & Johnson (Janssen Biotech) means that it will be able to launch ABP654 “no later than January 1, 2025.” Amgen’s biosimilar is not yet approved, and a 351(k) filing for ABP654 is expected later in 2023.
However, partners Alvotech and Teva expect an FDA decision on its own ustekinumab biosimilar ATV04 by end of this year. Formycon is also anticipated to file its a biologic licensing application for FYB202 in the third quarter of this year (see Table). These dates would suggest a potential initial launch as early as Q1 2024—if Alvotech receives a positive FDA decision. If there is a BPCIA patent suit pending against Alvotech, this launch could be delayed until 2025 as well.
Amgen’s settlement, first reported by Big Molecule Watch, raises the question of whether the other biosimilar contenders will seek settlements prior to marketing their drugs. This may seem eerily similar to what is occurring today with the sequential launches of Humira® biosimilars.
The Current Ustekinumab Pipeline
| Biosimilar Developer | Name | Stage/Status |
| Alvotech | AVT04 | 351(k) Application filed Jan 6, 2023; FDA decision expected Q4 2023 |
| Amgen | ABP654 | Phase 3 study completed; multiswitch study for interchangeability completed February 2023 |
| Bio-Thera | BAT2206 | Phase 3 study to be completed May 30, 2023 |
| Celltrion | CT-P43 | Phase 3 study completed May 2022 |
| Formycon/Bioeq | FYB202 | Phase 3 study completed, filing expected Q3-Q4 2023 |
| Samsung Bioepis | SB17 | Phase 3 study completed Nov 2022 |
| Biocon | Bmab1200 | Phase 3 study to be completed October 2023 |
| Neuclone | NeuLara | Phase 1 trial underway, no Phase 3 plans announced |
According to the FDA’s Purple Book, the subcutaneous form of ustekinumab was first approved in September 2009. Twelve patents are listed for Stelara, with two expiring September 25, 2023 and the rest expiring from 2032 to 2039 (including an intravenous formulation).
None of the other known biosimilar makers in contention for a first-approved ustekinumab biosimilar have publicly announced active litigation with Johnson & Johnson. This may not be surprising, if litigation is still in the early stages. It seems unlikely that Amgen is the only biosimilar maker sued by J&J under the BPCIA legislation of at least 6 who have completed/are completing phase 3 trials. We’ll be watching for further legal developments.
This is an interesting though unexpected follow-up on our last post, which discussed the apparent downward trend in BPCIA patent litigation of late.
*The Table was updated May 30, 2023 to reflect Biocon’s pipeline entry.
In Other Biosimilar News
Boehringer Ingelheim received approval from the FDA for its autoinjector option for delivering Cyltezo®. The adalimumab biosimilar will launch July 1, along with several others. This agent will be interchangeable with Humira® with its 50 mg/mL-dose formulation.
On May 16, Amneal announced that its pegfilgrastim biosimilar Fylnetra® is now available for prescription. No pricing was announced.
