On 10 October 2024, the US Food and Drug Administration (FDA) approved Accord’s Imuldosa (ustekinumab-srlf), making it the fifth ustekinumab biosimilar referencing Janssen/Johnson & Johnson’s Stelara.
Imuldosa (ustekinumab-srlf)
In the US, Imuldosa (ustekinumab-srlf) is approved to treat patients with autoimmune diseases including plaque psoriasis, paediatric psoriatic arthritis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It is available in concentrations of 45 mg/0.5 mL, 90 mg/mL, and 130 mg/26 mL for intravenous injection.
The FDA granted approval based on a comprehensive clinical development program that demonstrated Imuldosa’s similarity to Stelara in pharmacokinetic, safety, tolerability, and efficacy.
Development and Market Introduction
Imuldosa, also known as DMB-3115, was developed jointly by Korea’s Dong-A ST and Japan’s Meiji Seika Pharma. It was later acquired by Intas Pharmaceuticals in 2021 and will be marketed in the US by Accord Biopharma.
Accord anticipates a commercial launch no later than 15 May 2025, following patent litigation settlements in October 2023. While Stelara’s composition-of-matter patent expired in September 2023, none of the approved biosimilars have yet been launched in the US.
Approved Stelara Biosimilars
As the fifth Stelara biosimilar to receive FDA approval, Imuldosa joins a growing list of alternatives available to patients. Recent approvals include Formycon’s Otulfi (ustekinumab-aauz) in September 2024 [1]. Samsung Bioepis’ Pyzchiva (ustekinumab-ttwe) in July 2024 [2], Alvotech’s Selarsdi (ustekinumab-aekn) in April 2024 [3], and Amgen’s Wezlana (ustekinumab-auub) in October 2023, with Wezlana being the first interchangeable ustekinumab biosimilar [4].
Table 1 lists the currently approved Stelara biosimilars and their anticipated market entry dates. There are currently no ongoing patent disputes concerning Stelara biosimilars.
| Table 1: FDA-approved ustekinumab biosimilars by October 2024*
|
| Biosimilars
|
Therapeutic area
|
Authorization date
|
Manufacturer/
Company name
|
Market Entry Date
|
| Imuldose (ustekinumab-srlf)
|
Adult patients
Crohn’s disease
Plaque psoriasis (PsO)
Psoriatic arthritis (PsA)
Ulcerative colitis
Paediatric patients
Plaque psoriasis
Psoriatic arthritis (PsA)
|
10 Oct 2024
|
Accord
|
15 May 2025
|
| Otulfi (ustekinumab-aauz)
|
Active psoriatic arthritis
Crohn’s disease
Plaque psoriasis
Ulcerative colitis
|
27 Sep 2024
|
Fresenius Kabi
|
22 Feb 2025
|
| Pyzchiva (ustekinumab-ttwe)
|
Crohn's disease
plaque psoriasis
psoriatic arthritis
ulcerative colitis
|
28 Jun 2024#
|
Samsung Bioepis /Sandoz
|
22 Feb 2025
|
| Selarsdi (ustekinumab-aekn)
|
plaque psoriasis (PsO)
psoriatic arthritis (PsA)
|
16 Apr 2024
|
Alvotech, marketed by Teva
|
21 Feb 2025
|
| Wezlana (ustekinumab-auub)
|
Ankylosing spondylitis
Crohn’s disease
Juvenile arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
|
31 Oct 2023§
|
Amgen
|
1 Jan 2025
|
*Data updated 13 November 2024
§Denotes interchangeabile biosimilars
#Denotes approved with provisional interchangeable status without clinical switching studies
|
Additional Biosimilars and Pricing Implications
Proposed ustekinumab biosimilars submitted for FDA approval include Celltrion’s CT-P43, Biocon’s Bmab 1200, and Bio-Thera’s BAT2206, the latter of which includes a request for interchangeability.
Stelara has also been selected as one of the first 10 drugs for Medicare price negotiations under the Inflation Reduction Act, which will reduce its 30-day supply cost to US$4,695 (a 66% reduction from its 2023 price of US$13,836) starting 1 January 2026 under Medicare Part D. However, the launch of biosimilars in 2025 may influence its status on the Medicare list.
In Europe, Accord’s ustekinumab biosimilar has neem recommended for approval under two brand names: Imuldosa and Absimky [5].
Accord BioPharma, the US specialty division of Intas Pharmaceuticals Ltd, is focused on the development of oncology, immunology, and critical care therapies.
Related article
FDA BLA updates from Celltrion and Accord
References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves biosimilars: ustekinumab Otulfi and eculizumab Epysqli[www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 13]. Available from: www.gabionline.net/biosimilars/news/fda-approves-biosimilars-ustekinumab-otulfi-and-eculizumab-epysqli
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves third ustekinumab biosimilar Pyzchiva [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 13]. Available from: www.gabionline.net/biosimilars/news/fda-approves-third-ustekinumab-biosimilar-pyzchiva
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves ustekinumab, trastuzumab, and tocilizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 13]. Available from: www.gabionline.net/biosimilars/news/fda-approves-ustekinumab-trastuzumab-and-tocilizumab-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable ustekinumab biosimilar Wezlana [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 13]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-ustekinumab-biosimilar-wezlana
5. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval for ustekinumab biosimilar Absimky and Imuldosa [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 13].
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