FDA Tracker: Fresenius Kabi and Formycon’s Stelara Biosimilar Set for 2025 Launch

Settlements and Launch Dates:

Amgen's Stelara Biosimilar:
Set to launch no later than January 1, 2025, following a settlement with Johnson & Johnson.

Alvotech and Teva's Stelara Biosimilar:
Approved by the FDA and expected to launch on or after February 21, 2025, due to a legal settlement with J&J.

Fresenius Kabi and Formycon's Stelara Biosimilar:
Licensed to launch no later than April 15, 2025, as part of a settlement with J&J.

Market Impact:

Stelara Sales:
Stelara is a highly profitable drug for J&J, with $13.9 billion in sales in 2022, making it a significant target for biosimilar competition.

Competition and Price Declines:
The entry of biosimilars is expected to lead to price declines and market share shifts, impacting J&J's revenue from Stelara.

Regulatory Approvals:

FDA Approvals:
The FDA has approved biosimilars from Amgen (Wezlana) and Alvotech/Teva (Selarsdi), with Fresenius Kabi and Formycon's biosimilar awaiting approval.

Global Launches:

Alvotech's Global Plans:
Alvotech plans to launch its Stelara biosimilar in Canada, Japan, and Europe in 2024, following settlements with J&J.

Legal Battles:

CareFirst Lawsuit:
CareFirst BlueCross BlueShield has filed a lawsuit against J&J, alleging that the company is delaying biosimilar competition for Stelara, creating a monopoly beyond the legitimate patent exclusivity period.