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Xbrane’s Ranibizumab Marches On With US FDA Filing Imminent

Swedish Firm Reveals Further Phase III Data For Proposed Lucentis Biosimilar

 
• By Dean Rudge

With Samsung Bioepis already holding US and EU approvals for biosimilar ranibizumab, Swedish sponsor Xbrane Biopharma says 12-month Phase III data supports ongoing registration of the Lucentis rival in both regions.

Eye
Xbrane is chasing approvals like the ones held by Samsung Bioepis • Source: Shutterstock

The first anticipated launches of biosimilars referencing Genentech/Novartis’ Lucentis (ranibizumab) eye-disease biologic, addressing the $13bn global retinal anti-VEGF market, are just months away.

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Lupin Touts FDA Approval For Generic Tolvaptan With 180-Day Exclusivity

 
• By Urtė Fultinavičiūtė

After receiving a favorable court ruling last year, Lupin has secured its first-place spot for generic tolvaptan tablets in the US.

Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By Dave Wallace

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Amgen’s Aflibercept Starts Strong As Regeneron Counts Cost Of Eylea Competition

 
• By Dean Rudge

Amgen told investors during its 1 May first-quarter earnings call that its Pavblu biosimilar to Eylea 2mg had flown out of the gates, while Regeneron admitted “some difficult news related to our retinal franchise.”

BGMA Becomes Medicines UK

 
• By Dave Wallace

The UK generics and biosimilars industry will now be represented by Medicines UK, the new name for the former British Generic Manufacturers Association.

More from Generics Bulletin

Amgen’s Aflibercept Starts Strong As Regeneron Counts Cost Of Eylea Competition

 
• By Dean Rudge

Amgen told investors during its 1 May first-quarter earnings call that its Pavblu biosimilar to Eylea 2mg had flown out of the gates, while Regeneron admitted “some difficult news related to our retinal franchise.”

BGMA Becomes Medicines UK

 
• By Dave Wallace

The UK generics and biosimilars industry will now be represented by Medicines UK, the new name for the former British Generic Manufacturers Association.

J&J Denied Injunction Over Private-Label Ustekinumab In US

 
• By Dave Wallace

Stelara originator J&J has been denied in its initial attempt to prevent Samsung Bioepis and ustekinumab biosimilar partner Sandoz from selling a private-label version of the product through a PBM in the US.