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Taking Stelara By Stealth? Amgen Stays Silent On US Ustekinumab Launch

All Quiet On The Wezlana Front As Amgen Declines To Offer Any Details

 
• By Dave Wallace

While Amgen had been expected to launch its Wezlana interchangeable biosimilar to Stelara from 1 January in the US, the firm has so far been quiet on details – including on the pricing strategy for its rival to the $10bn+ brand.

Amgen is keeping quiet over its Wezlana launch

Amgen may be launching the first US biosimilar rival to Stelara (ustekinumab) this month, but it doesn’t seem to want to talk about it.

Despite the firm having gained the first US Food and Drug Administration approval for its Wezlana (ustekinumab-auub) version in 2023 – along with a coveted interchangeability designation – and...

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...

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More from Biosimilars

Amgen And Samsung Soliris Biosimilars Skirt UK Infringement On Claim Construction

 
• By Dean Rudge

Just days after a court in Canada barred Amgen’s Soliris biosimilar until patent expiry in 2027, a UK High Court has handed a favorable ruling to the California-based firm and Samsung Bioepis, ruling that their products do not infringe a patent shielding the branded treatment for paroxysmal nocturnal hemoglobinuria.

Formycon Hopes Stelara Biosimilar Sales To Pull Through FY2025 As Q1 Revenues Slump

 
• By Urtė Fultinavičiūtė

Formycon said it predicted low earnings in the first quarter of 2025, after enjoying milestone payments last year. Now, the pressure is on the growing biosimilars portfolio to pull the company through this year.

Gedeon Richter Feels Biosimilar Model ‘Is Looking For An Equilibrium’

 
• By Dean Rudge

Gedeon Richter’s CEO weighed in on the pricing landscape for biosimilars as the firm admitted the market for biosimilar denosumab was set to be more crowded than it had initially anticipated.

Aurobindo Racks Up Another Biosimilar Nod With Filgrastim In UK

 
• By Dave Wallace

Aurobindo’s run of biosimilar registration successes continues, with the firm’s CuraTeQ subsidiary picking up approval for its Zefylti version of filgrastim in the UK.

More from Generics Bulletin

ANI Raises Generics Guidance As Exclusive Prucalopride Drives Growth

 
• By Dean Rudge

ANI Pharmaceuticals says it has delivered an “exceptionally strong first quarter,” with total sales reaching over $197m, amid plans to kick off a Phase IV clinical trial for Cortrophin Gel for acute gouty arthritis later this year.

Aurobindo, MSN Fall To US Nuplazid Patent Expiring In August 2038

 
• By Dean Rudge

Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis is looking safe from generic competition – for now – until well into the next decade, following a favorable infringement and validity decision by a US district court.

Aurobindo Racks Up Another Biosimilar Nod With Filgrastim In UK

 
• By Dave Wallace

Aurobindo’s run of biosimilar registration successes continues, with the firm’s CuraTeQ subsidiary picking up approval for its Zefylti version of filgrastim in the UK.