Johnson & Johnson (J&J) has filed a lawsuit in New Jersey federal court against Samsung Bioepis, claiming a breach of their settlement agreement regarding the launch of Pyzchiva, a biosimilar version of J&J's blockbuster psoriasis treatment Stelara. The legal action centers on an alleged unauthorized sublicense agreement with an undisclosed private label provider.
Legal Battle Details
The lawsuit, filed Monday, seeks both preliminary and permanent injunctions to prevent U.S. sales of the private-label version of Pyzchiva. J&J argues that while their July 2023 settlement agreement permitted Samsung Bioepis to launch Pyzchiva this month, it did not authorize the introduction of an additional private label drug that could unfairly impact J&J's market share and competition.
Market Impact and Commercial Significance
Stelara has been J&J's leading pharmaceutical product since 2019, generating more than $10 billion in sales in 2024. The medication's patent expiration in 2023 has opened the door for biosimilar competition, though legal agreements have somewhat delayed their market entry in the United States.
Biosimilar Landscape and Market Dynamics
J&J's CFO Joe Wolk has drawn parallels between the Stelara biosimilar market and AbbVie's experience with Humira biosimilars. The comparison is particularly relevant given recent market developments where CVS Health's decision to remove Humira from its covered drugs list led to a significant shift in patient adoption of biosimilars.
Current Market Status
Samsung Bioepis and their partner Sandoz have already launched Pyzchiva in the U.S. market. The biosimilar has received approval for multiple indications, including:
- Moderate to severe plaque psoriasis
- Active psoriatic arthritis
- Moderately to severely active Crohn's disease
- Moderately to severely active ulcerative colitis
Competitive Environment
The biosimilar landscape for Stelara is becoming increasingly competitive. Teva Pharmaceuticals and Alvotech recently launched their biosimilar, Selarsdi, though its interchangeability designation won't take effect until after April 30, when Amgen's Wezlana's exclusive rights expire. Industry experts anticipate at least seven Stelara biosimilars will enter the U.S. market this year, marking a significant shift in the treatment landscape for multiple inflammatory conditions.
