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Amgen Will Launch First US Eylea Biosimilar At Risk

First US Aflibercept Is On The Way After Amgen Dodges Another Attempt At Injunction

 
• By Dean Rudge

A watershed moment is on the horizon for US biosimilars, with Amgen looking poised to debut competition to Eylea (aflibercept).

Businessman showing risk level indicator rating since low to high for risk management and assessment review concept
• Source: Shutterstock

The first US biosimilar to Regeneron’s Eylea (aflibercept) 2mg is imminent, after biosimilar sponsor Amgen obtained another favorable court decision.

The US Court of Appeals for the Federal Circuit on 22 October denied Regeneron’s motion for an injunction pending appeal...

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Bio-Thera Matches Alvotech With US Golimumab Filing Acceptance

 
• By Dean Rudge

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Samsung Bioepis Finds New US Partner For Ophthalmic Biosimilars

 
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‘Our Position Has Naturally Shifted’ – How Standalone Sandoz Is Taking On Originator Abuses

 
• By Dave Wallace

As a standalone generics and biosimilars company, Sandoz now feels freer to speak out against originator abuses of intellectual property, the firm’s global IP head Julia Pike tells Generics Bulletin, including challenges to Bayer on rivaroxaban and Amgen on etanercept.

Kirsty Gives Biocon A First Interchangeable US Insulin Aspart Biosimilar

 
• By Dave Wallace

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More from Legal & IP

MSN Labs Swerves 2026 US Entresto Patent Ahead Of Separate July 15 Expiry

 
• By Dean Rudge

Novartis has filed an immediate appeal after a US district court ruled that MSN Labs would not infringe one of its key patents shielding its $7.8bn Entresto brand, and denied the originator injunctive relief.

US Federal Circuit Says No To Teva And Viatris On Remanded Invega Sustenna Appeal

 
• By Dean Rudge

Just days after Viatris was frustrated in its attempts to challenge IP protecting Janssen’s Invega Trinza, the US Federal Circuit has rejected the firm’s and Teva’s bid to invalidate a patent shielding the one-month version of the brand, Invega Sustenna.

‘Prescription Drugs Are Not Golf Balls’ – Opinions Clash On Patents During FTC/DOJ Listening Session

 
• By Urtė Fultinavičiūtė

Pro-innovator voices argued that the number of patents asserted in the pharma industry is not too dissimilar to other fields. But should drugs be compared to golf balls?