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FDA Exploring Whether Public Shaming Can Stop REMS Abuses

 
• By Derrick Gingery

Commissioner Gottlieb says agency is considering publicizing letters it has written to brand companies indicating it would not violate a REMS to sell a generic company samples for testing.

FDA entrance sign 2016

The US FDA may resort to using its bully pulpit to lessen REMS abuses that prevent generic entry.

Agency letters to brand companies indicating it is acceptable under a Risk Evaluation and Mitigation Strategy (REMS) to sell samples to a generic company for testing may be made public,...

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‘Obsessive’ Teva Aims For $800m Biosimilar Sales By 2027

 
• By Dean Rudge

Teva says it is now in the “accelerate growth” phase of its strategic roadmap, with global biosimilar launches set to help the firm achieve its goals.

Trump-Trimmed FDA Finally Releases A Batch Of PSGs – Back To Business As Usual?

 
• By Urtė Fultinavičiūtė

After half a year of silence, the US FDA has published 48 product-specific guidances for generic development. With critical staff laid off, will the health agency stick to its updated PSG publishing schedule?

Fresenius Adds To Denosumab Competitors In Europe

 
• By Dave Wallace

At a busy meeting of the CHMP, the EMA issued positive opinions for Fresenius Kabi’s denosumab rivals to Prolia and Xgeva, another denosumab biosimilar from Sandoz, a Tecfidera hybrid from Neuraxpharm and a Descovy generic from Viatris. Meanwhile, Ascend has withdrawn a teriparatide filing.

After Dasatinib Apotex Debuts US Tasigna Competition

 
• By Dean Rudge

Canada’s Apotex is continuing to spearhead generic competition in the tyrosine kinase inhibitor (TKI) space for chronic myelogenous leukemia, with the launch of the first generic version of Novartis’ Tasigna (nilotinib) blockbuster.

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Alvotech And Advanz Add Three More In €160m EU Partnership Expansion

 
• By Dean Rudge

Fresh from filing a proposed biosimilar to Xolair (omalizumab) in the UK, Alvotech and Advanz have shaken hands on a further deal to expand their partnership.

After Dasatinib Apotex Debuts US Tasigna Competition

 
• By Dean Rudge

Canada’s Apotex is continuing to spearhead generic competition in the tyrosine kinase inhibitor (TKI) space for chronic myelogenous leukemia, with the launch of the first generic version of Novartis’ Tasigna (nilotinib) blockbuster.

Abiogen And mAbxience Join Forces In Italy

 
• By Dave Wallace

Spanish biosimilars developer mAbxience has struck a deal with Italy’s Abiogen covering an undisclosed biosimilar for the Italian market.