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

Key Trial Kicks Off For Viatris; US Treanda Generics Set To Debut

 
• By Dean Rudge

In a busy final month of the year, key legal action will be heard in both the US and Europe, while the Medicines Patent Pool will hear from applicants for a milestone voluntary licensing agreement covering Novartis’ nilotinib.

What's Next Image
Much is to come at the end of 2022 • Source: Citeline

Viatris may have removed recently another significant legal hurdle to launching its Breyna US generic version of AstraZeneca’s Symbicort (budesonide/formoterol fumarate dihydrate) pressurized metered dose inhaler, but it is not out of the woods yet.

The ANDA sponsor is set to face trial against the UK-based originator over a fifth asserted Symbicort patent, US patent...

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More from Biosimilars

Xbrane Sets Date For Latest Run At Ranibizumab In US

 
• By Dave Wallace

After a series of setbacks for its Lucentis (ranibizumab) biosimilar filing in the US, Xbrane Biopharma now has a fresh action date from the FDA – although any approval will be contingent on a successful agency reinspection of its manufacturing sites.

Dr Reddy’s And Alvotech Team Up On Keytruda Rival

 
• By Dave Wallace

After previously partnering on denosumab, Alvotech and Dr Reddy’s have announced a further alliance to co-develop a biosimilar version of Keytruda (pembrolizumab).

The Generics Bulletin Podcast: The Global Generics & Biosimilars Awards 2025

 
• By Dave Wallace and Dean Rudge

With entries now open for the Global Generics & Biosimilars Awards 2025 – which takes place in Frankfurt on Wednesday 29 October – Generics Bulletin’s editors discuss all the key details, including tips for entrants, in our latest podcast.

UK-EU Deal ‘Must Include Medicines, Not Just Sausages,’ Urges Medicines UK

 
• By Urtė Fultinavičiūtė

The UK struck three international agreements in May, but two of them failed to include medicines or provide any benefits for the pharmaceutical sector. Medicines UK warned that protecting medicine supplies should be of the same importance as defense.

More from Products

Shilpa Stumbles On Lenvima Challenge And Faces Wait Until 2036

 
• By Dean Rudge

Generic competition to Eisai’s oral-dose blockbuster cancer therapy Lenvima is set to materialize in the US in 2030 – however, for now, that won’t be from ANDA filer Shilpa Medicare.

The Generics Bulletin Podcast: The Global Generics & Biosimilars Awards 2025

 
• By Dave Wallace and Dean Rudge

With entries now open for the Global Generics & Biosimilars Awards 2025 – which takes place in Frankfurt on Wednesday 29 October – Generics Bulletin’s editors discuss all the key details, including tips for entrants, in our latest podcast.

Loss Of Exclusivity Product Launches To Fuel Aurobindo’s FY26 Europe Growth

 
• By Vibha Ravi

Aurobindo is banking on launches of loss of exclusivity products and biosimilars to fuel sales in Europe as it awaits a US announcement on tariffs and predicts high single-digit growth overall during FY26 for now