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Alvotech Lauds Development, Manufacturing Platform As Ustekinumab Wins US Approval

Commercial Partner Teva Eyes Launch In February 2025 For Rival To $7bn Blockbuster

 
• By Dean Rudge

Alvotech’s high confidence for FDA approval for its Stelara biosimilar has been justified, as the Icelandic firm announced only the second US approval for a rival to J&J’s Stelara powerhouse brand, ahead of market formation in 2025.

FDA approved
• Source: Shutterstock

Alvotech has secured US Food and Drug Administration approval for its Selarsdi (ustekinumab-aekn) subcutaneous injectable biosimilar to Stelara, the Icelandic firm’s second major US biosimilar approval in the last two months and a significant boost for its commercialization partner Teva ahead of expected launch in February 2025.

The Icelandic firm announced its approval late on Tuesday for its biosimilar interleukin-12 and -23 antagonist for the treatment of moderate to severe plaque psoriasis and for active psoriatic

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Aurobindo Racks Up Another Biosimilar Nod With Filgrastim In UK

 
• By Dave Wallace

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J&J Hits Back Over Private-Label Stelara Biosimilar In US

 
• By Dave Wallace

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Hikma Eyes $5bn Sales Target As It Sets Out Plans To 2030

 
• By Dave Wallace

Unveiling a new name for its generics business, Hikma has at the same time set out medium-term financial goals for its business that include three-year growth objectives for its sales and profits, as well as aiming at a $5bn turnover target by 2030.

Cipla Leadership’s Early Take On Trump’s Pricing EO And Pipeline Progress

 
• By Anju Ghangurde

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Gedeon Richter: General Medicines Unit Deserves ‘More Attention And Credit’

 
• By Dean Rudge

Gedeon Richter’s CEO has urged analysts and the firm itself to give more attention to its “unfairly neglected” General Medicines division – which includes both generics and licensed-in innovative products – during the Hungarian firm’s first-quarter earnings call.

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.

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.