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Alvotech And Reddy’s Await US Denosumab Decision As Launch Date Closes In

Icelandic Firm’s AVT03 Rival Accepted For Review; Fresenius Kabi Just Settled Litigation

 
• By Dean Rudge

With Sandoz set to debut US competition to Prolia and Xgeva in a matter of months, other biosimilar sponsors are working hard to ensure launch of Amgen’s blockbuster in a timely manner.

Accepted_Stamp
• Source: Shutterstock

Alvotech’s AVT03 proposed biosimilar to Prolia/Xgeva (denosumab) has been successfully filed by its partner Dr Reddy’s Laboratories with the US Food and Drug Administration, in the latest development in the busy chase for rivals to Amgen’s osteoporosis and bone cancer treatments.

An update posted by the two firms confirmed earlier comments made by the Indian company.

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Kirsty Gives Biocon A First Interchangeable US Insulin Aspart Biosimilar

 
• By Dave Wallace

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Making The UK A Leading Biosimilar Launch Destination – Realistic Or Optimistic?

 
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Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
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As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Biocon’s Denosumab Biosimilar Approved In The UK As Competition Grows In Europe

 
• By Urtė Fultinavičiūtė

Denosumab biosimilar ranks are filling up in Europe as approvals flood in. Yet, little is known about the launch dates.

More from Generics Bulletin

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By Dave Wallace

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Wockhardt Pivots To Biosimilar Insulins Focus As It Confirms US Generics Exit

 
• By Dean Rudge

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The Politics Of Divisionals: How European Patentees Are Still Gaming The System

 
• By Dave Wallace

At Medicines for Europe’s legal affairs conference last month, divisional patents were once again a major subject of discussion. Attendees heard fresh details of how patentee games are preventing generics from hitting the market and restricting wider access to major medicines.