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

Teva And Viatris Follow Sandoz On Q1; Key Cabometyx Trial Set To Begin

01 May 2022

This month, Eli Lilly’s Alimta blockbuster will lose patent protection in the US, while Teva – which will also publish its Q1 financial results – will see Bristol Myers Squibb begin its appeal process against a key UK ruling involving the originator’s Eliquis (apixaban) anticoagulant.

What's Next Image — May's schedule includes Q1 results and a key ANDA trial • Source: Informa

What will industry giants Teva and Viatris offer up when they publish their first quarter financial results early in this month?

Teva, which will publish first of the two on 3 May, had indicated earlier this year that 2022 was set to be a trough year for the company – or...

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

30 May 2025

• 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?

30 May 2025

• 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

29 May 2025

• 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 Meanwhile, Ascend has withdrawn a teriparatide filing.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

28 May 2025

• 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.

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

29 May 2025

• 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.