What’s Next? Five Things To Look Out For In October

UK Xolair And US Abilify Maintena Patent Trials; Eleventh Generics Awards In Milan

Generics Bulletin previews the most notable and anticipated events for October 2024.

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This month, patent court trial proceedings are expected to get underway in the UK in Celltrion’s bid to secure a declaration that the local part of a key European patent shielding Novartis/Genentech’s Xolair (omalizumab) is invalid, or not infringed, by the Korean firm’s Omlyclo version.

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Teva Provigil ‘Pay For Delay’ Fines Should Stand, AG Says

 
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Teva should not be able to overturn European fines imposed over a historical “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil), an advocate general of the CJEU has recommended.

Who’s Hired? Alvotech Appoints Strategy And Quality Chiefs

 
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Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.

Optum Rx Remodels Payment Model To Favor Generics – A Peace Offering For FTC?

 

Optum Rx, one of the largest PBMs in the US, declared itself as the “first comprehensive, transparent pharmacy services company” after announcing several consumer-friendly changes.

Combating Bioequivalence Data Fraud: Indian CROs Face Mandatory Registration

 

As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.

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Celltrion Plans Multiple US Biosimilar Launches In An ‘Exciting And Momentous’ Year

 
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With Celltrion having just received approval for its US Actemra (tocilizumab) biosimilar and having just launched its ustekinumab rival to Stelara – and with the introduction of the Korean developer’s denosumab rivals to Prolia and Xgeva just around the corner – 2025 is set to be a busy year, Celltrion USA chief commercial officer Thomas Nusbickel tells Generics Bulletin.

Alvotech Reveals Ramp-Up In Development As Sales Explode In 2024

 
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With sales and profits shooting up in 2024, Alvotech has revealed plans to rapidly accelerate development to add between four and six programs to its pipeline of biosimilars every year, while at the same time unveiling details of several new brands that it will be seeking to challenge. The firm has also set out longer-term financial targets that anticipate more than trebling its revenues in the next three years.

Dr Reddy’s Bags Rights To Two More Biosimilars In Deal With Bio-Thera

 
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India’s Dr Reddy’s and China’s Bio-Thera have struck a deal covering ustekinumab and golimumab biosimilars in multiple markets in south-east Asia.