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Who Will Emerge Victorious In US Showdown On Stelara?

Seven Approved Ustekinumab Biosimilars Set To Launch In Early 2025

 
• By Dave Wallace

US biosimilar competition to Stelara is waiting in the wings from the very start of 2025. But with seven ustekinumab rivals already approved by the FDA and set to launch, how will things shake out in such a crowded market? Generics Bulletin looks at the contenders.

Which competitors will rise to the top on ustekinumab? (Shutterstock)

For US biosimilars, Stelara (ustekinumab) is to 2025 what Humira (adalimumab) was to 2023, in terms of being the biggest launch on the horizon in terms of the potential loss-of-exclusivity opportunity.

With Stelara having grown to become a $10.9bn brand in 2023 – of which nearly $7bn in sales came from the US market alone – the total might not quite match the $17bn in US sales commanded by Humira

FDA-Approved Biosimilars Of Stelara (Ustekinumab)

Amgen’s Wezlana (ustekinumab-auub) – Approved October 2023

Alvotech and Teva’s Selarsdi (ustekinumab-aekn) – Approved April 2024

Samsung Bioepis and Sandoz’s Pyzchiva (ustekinumab-ttwe) – Approved June 2024

Fresenius Kabi and Formycon’s Otulfi (ustekinumab-aauz) – Approved September 2024

Dong-A ST/Meiji Seika Pharma and Accord’s Imuldosa (ustekinumab-srlf) – Approved October 2024

More from Biosimilars

Amgen Locked Out Of Canadian Eculizumab Market Until 2027

 
• By Dean Rudge

Rejecting Amgen’s challenges on the grounds of anticipation and obviousness, Canada’s Federal Court has issued an injunction against the biosimilars firm until patent expiry in March 2027.

‘We Can’t Keep Going On Like This’ – Biosimilars Forum’s Reed Calls For Urgent Changes In US

 
• By Dave Wallace

As the US biosimilars market moves into its second decade, urgent changes are needed at the FDA if biosimilars are to meet their full potential, according to Biosimilars Forum chief executive Julie Reed.

Biocon Biologics Plans To Slow Down After Five Planned Near-Term Biosimilar Launches

 
• By Urtė Fultinavičiūtė

With a lineup of five high-value biosimilars in the wings, Biocon Biologics may be more selective going forward and plans to take a one product per year approach.

Cutting Out The Middlemen? Trump’s Pricing Order Offers Opportunity On PBMs

 
• By Dave Wallace

Donald Trump’s executive order on most-favored-nation prescription drug pricing could provide positive opportunities for the off-patent industry, although US generics and biosimilars association the AAM suggested that the administration might do more good by focusing elsewhere.

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