Hikma Launches First US Biosimilar STARJEMZA, Seventh Ustekinumab Alternative to Enter Market
Key Insights
Hikma Pharmaceuticals launched STARJEMZA (search) (ustekinumab-hmny (search)) on November 6, 2025, marking the company's first biosimilar entry into the US market.
The biosimilar references Janssen's STELARA and is approved for treating plaque psoriasis (search), psoriatic arthritis (search), Crohn's disease (search), and ulcerative colitis (search).
STARJEMZA (search) became the seventh ustekinumab biosimilar to receive FDA approval on May 22, 2025, developed by Bio-Thera under a 2021 partnership agreement.
Hikma Pharmaceuticals PLC and its subsidiary Hikma Pharmaceuticals USA Inc. announced the commercial launch of STARJEMZA (search) (ustekinumab-hmny (search)) on November 6, 2025, marking a significant milestone as the company's first biosimilar product to enter the US market. The biosimilar references Janssen's blockbuster drug STELARA and is indicated for the treatment of plaque psoriasis (search), psoriatic arthritis (search), Crohn's disease (search), and ulcerative colitis (search).
"We are excited to launch our first biosimilar in the US," said Craig Boyd, commercial lead for the biosimilar, highlighting the strategic importance of this launch for Hikma's expanding portfolio.
FDA Approval and Market Position
STARJEMZA (search) received FDA approval on May 22, 2025, becoming the seventh ustekinumab biosimilar to gain regulatory clearance in the United States. This approval adds to the growing competitive landscape for ustekinumab alternatives, providing healthcare providers and patients with additional treatment options for inflammatory conditions.
The biosimilar's approval and launch represent the culmination of a strategic partnership between Hikma and Bio-Thera Solutions, established through an agreement signed in August 2021. Under this collaboration, Bio-Thera handled the development and manufacturing of STARJEMZA (search), while Hikma took responsibility for commercialization in the United States.
Therapeutic Applications
STARJEMZA (search) is approved for the same indications as the reference product STELARA, targeting multiple inflammatory conditions that affect millions of patients. The biosimilar offers treatment options for:
- Plaque psoriasis, a chronic autoimmune skin condition
- Psoriatic arthritis, which combines skin and joint inflammation
- Crohn's disease, an inflammatory bowel condition
- Ulcerative colitis, another form of inflammatory bowel disease
Strategic Partnership Model
The collaboration between Hikma and Bio-Thera exemplifies the strategic partnerships increasingly common in biosimilar development. Bio-Thera's expertise in biosimilar development and manufacturing complemented Hikma's commercial capabilities and US market presence, enabling the successful launch of STARJEMZA (search).
This partnership model allows companies to leverage their respective strengths while sharing the risks and investments associated with biosimilar development, which typically requires substantial resources and regulatory expertise.