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‘At The End Of The Day, It’s A Huge, Huge Opportunity’ – Teva’s Rainey Talks Stelara

Tom Rainey, SVP Of US Market Access At Teva, Discusses The Firm’s US Biosimilars Business

 
• By Dave Wallace

Teva is ramping up its activities in US biosimilars, with the launch of its Alvotech-partnered Humira rival imminent and a Stelara biosimilar slated for launch in February 2025. Tom Rainey, the firm’s senior vice president of US market access, talks about the opportunities on the horizon and how the firm is balancing its partnership model with in-house development.

Teva logo outside company building
Teva is eyeing biosimilar opportunities • Source: Shutterstock

With Teva recently gaining two US Food and Drug Administration biosimilar approvals in quick succession for its Alvotech-partnered Humira (adalimumab) and Stelara (ustekinumab) rivals, the company’s CEO Richard Francis recently talked in detail about how the firm sees the adalimumab market shaping up ahead of the firm’s imminent launch of its Simlandi (adalimumab-ryvk) version. (Also see "Teva Plans To Launch Six Biosimilars By 2027" - Generics Bulletin, 14 May, 2024.)

But coming just a matter of months after that launch will be a second, arguably even more meaningful biosimilar launch for Teva, in the form of its

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• 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.

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.

Generics Bulletin Explains: The Landscape For Denosumab Biosimilar Competition

 
• By Dave Wallace

One of the biggest biologic loss-of-exclusivity opportunities of the year is almost upon us, as biosimilars developers across the world get ready to launch rivals to Amgen’s denosumab brands Prolia and Xgeva. Generics Bulletin offers a rundown of some of the major contenders and how they view the market.

Teva And Alvotech Celebrate Interchangeability For US Ustekinumab

 
• By Dave Wallace

The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.

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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.