Earlier this month, Accord BioPharma announced that it had submitted its 351(k) biosimilar application to the FDA for DMB-3115, a proposed ustekinumab biosimilar. An FDA decision may come as early as late Q4 2024.
The application for DMB-3115 includes study results from a phase 3 clinical trial in patients with plaque psoriasis, in which DMB-3115 was found to be noninferior to the reference product Stelara®.
| Biosimilar Developer | Name | Stage/Status |
| Accord BioPharma/Intas | DMB-3115 | FDA application filed Jan 4, 2024. Q4 2024 decision? |
| Alvotech/Teva | AVT04 | 351(k) Application filed Jan 6, 2023; FDA rejected Oct 2023 |
| Amgen | Wezlana | Approved Oct 31 as interchangeable; launch date Jan 2025 |
| Biocon | Bmab1200 | Phase 3 study to be completed October 2023 |
| Bio-Thera/Hikma | BAT2206 | Phase 3 study completed July 2023; FDA filing expected Q1 ‘24 |
| Formycon/Bioeq | FYB202 | Phase 3 study completed, filing expected Q4 2023; launch date April 2025 |
| Neuclone | NeuLara | Phase 1 trial underway |
| Samsung Bioepis | SB17 | Phase 3 study completed Nov 2022 |
In the company’s press release, Chrys Kokino, U.S. President of Accord, stated, “The ability of [ustekinumab] to treat autoimmune diseases is well established, and we’re excited to take this important step toward providing patients a more accessible avenue to treatment for conditions that present such a significant disease burden.”
DMB-3155 represents Accord BioPharma’s third 351(k) application. A biologic licensing application was submitted in April 2023 for HLX02, a biosimilar version of trastuzumab. The company mentioned in its current press release that it also has biologic licensing applications under consideration by the FDA for pegfilgrastim and filgrastim; these are not mentioned on the company’s website and were not publicly announced previously (we could not confirm their status).
Accord BioPharma is the specialty division of India-based Intas Pharmaceuticals, which holds commercialization rights to DMB-3115. The new biosimilar would be manufactured through a partnership with Dong-A Socio Holdings and Meiji Seika Pharma (two South Korean manufacturers), according to the press release.
Accord has a scheduled launch date of no later than May 15, 2025, negotiated with Janssen Biotech, maker of the originator product. This would be the fifth announced launch agreement with Janssen, following those previously disclosed with Amgen, Alvotech/Teva, Fresenius Kabi/Formycon, and Celltrion. At least two other ustekinumab biosimilars may be in the running as well.