1. Generics Bulletin
  2. >>Products

Trailblazer Amgen Scoops First US Stelara Biosimilar – With Interchangeability

California-Based Biotech Can Launch Wezlana On Or Before 1 January 2025

 
• By Dean Rudge

With its portfolio of biosimilars continuing to grow, Amgen has received the first approval in the US for a biosimilar to Stelara – weeks after Alvotech/Teva was hit with a complete response letter.

Timeline years 2025 blue pin
• Source: Olivier Le Moal / Alamy Stock Photo

Amgen can now look forward with certainty to launching its biosimilar to Johnson & Johnson’s Stelara (ustekinumab) blockbuster treatment for autoimmune diseases no later than the 1 January 2025.

The US Food and Drug Administration has granted approval for the company’s Wezlana (ustekinumab-auub) as both a biosimilar to and interchangeable with Stelara, the first

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Products

Tetris Deal Falls Into Place For UK’s Aspire

 
• By Dave Wallace

Niche generics company Aspire Pharma has struck a deal to acquire a portfolio of products from fellow UK firm Tetris Pharma as it is wound up, paying Tetris parent Arecor £0.5m for UK distribution rights and inventory.

Apotex Extends Formosa Ophthalmic Alliance Into Mexico

 
• By Dave Wallace

Apotex has expanded an alliance formed with Formosa in August for its novel clobetasol propionate ophthalmic treatment, adding Mexican rights to its existing deal for the Canadian market.

Fresenius Kabi Lauds Tocilizumab Momentum As ‘Intense’ Transfer To mAbxience Continues

 
• By Dean Rudge

Fresenius Kabi continued to reap the rewards of its fledgling commercial Biopharma business in the first quarter, as the firm eyes further growth for its tocilizumab biosimilar in the US and Europe in the second half of 2025.

US FDA Expands Surprise Foreign Inspections

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

More from Generics Bulletin

After Jazz, Hikma Agrees $50m Settlement For ‘Most’ Xyrem ‘Pay-For-Delay’ Claims

 
• By Dean Rudge

Hikma said it would admit no wrongdoing or liability after reaching a preliminary settlement agreement over illicit ‘pay-for-delay’ claims involving its US version of Xyrem “that protects the company’s interests and provides clarity to our stakeholders.”

CIOMS Welcomes Draft Report Feedback On The Inevitable Future Of AI In Pharmacovigilance

 
• By Urtė Fultinavičiūtė

Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.

Viatris Pens Aprepitant Settlement Agreement After Kabi Loses Initial Patent Case

 
• By Dean Rudge

Viatris will look to introduce generic versions of Heron Therapeutics’ aprepitant brands, Cinvanti and Aponvie, around three years before patent expiry after settling litigation with the originator. Other court cases remain ongoing.