The FDA approved Alvotech's biosimilar of Johnson & Johnson's top-selling drug Stelara, called Selarsdi, intended for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis in both adults and children aged six years and older. Teva Pharmaceuticals, Alvotech's partner, will market the biosimilar in the US following a settlement with J&J, with the product set to be launched on or after Feb. 21, 2025. This is the second biosimilar to receive approval under a partnership between Alvotech and Teva, with Stelara generating sales of around $10.9B in 2023 as J&J's best-selling drug.
Key Takeaways
- The FDA has approved Alvotech's biosimilar of Johnson & Johnson's top-selling drug Stelara, called Selarsdi.
- Selarsdi is approved for treating moderate-to-severe plaque psoriasis and active psoriatic arthritis in adults and children aged six years and older.
- Teva Pharmaceuticals is set to market Selarsdi in the US after a settlement with J&J, with the launch scheduled for Feb. 21, 2025.
- Selarsdi is the second biosimilar approved under the partnership between Alvotech and Teva, with Stelara generating sales of around $10.9B in 2023.
Analysis
The approval of Alvotech's biosimilar, Selarsdi, poses a significant market disruption for Johnson & Johnson's top-selling drug, Stelara, with potential financial repercussions. J&J's sales are likely to be impacted by the biosimilar's entry into the market, potentially leading to a decline in revenue. Additionally, the partnership between Alvotech and Teva Pharmaceuticals could strengthen their positions in the pharmaceutical industry, challenging the dominance of established players. This approval marks a growing trend in the biosimilars market, with potential long-term implications for market competitiveness and pricing strategies. The launch of Selarsdi could present a pivotal shift in the treatment landscape for plaque psoriasis and psoriatic arthritis.
Did You Know?
- Biosimilar: A biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. In this case, Alvotech's biosimilar of Johnson & Johnson's drug Stelara, called Selarsdi, has been approved by the FDA for treating psoriasis and psoriatic arthritis.
- Partnership Settlement: Refers to the agreement reached between Teva Pharmaceuticals and J&J regarding the marketing and launch of Selarsdi in the US. This settlement allows Teva Pharmaceuticals to bring the biosimilar to the market after a specific date.
- Stelara Sales: Indicates the significant sales volume of J&J's drug Stelara, giving an insight into its market dominance and the potential impact of Selarsdi's approval.