US FDA's Generic Research Projects Appear To Be Opening Way For ANDAs

Pre-ANDA meeting requests were high in some product categories where FDA conducted research projects, suggesting agency may influence sponsors' development priorities.

FY13-FY17 Linkage of Research To Pre-ANDA Meetings — In some generic product categories where there were many FDA research projects, there also were several pre-ANDA meeting requests, suggesting the studies may have helped sponsors move forward with development. • Source: FDA presentation slides

It appears the US FDA may be able to influence generic drug sponsors' development priorities with its research projects, or at least pique their interest.

Data suggests that pre-ANDA meeting requests sometimes correlate with the number of internal and external research projects in the category, particularly when it comes to complex generics. Agency studies may...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

Start your 7-day free trial
Explore trusted news, analysis, and insights
Access comprehensive global coverage
Enjoy instant access – no credit card required

Start Free Trial

Already a subscriber?

‘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 Meanwhile, Ascend has withdrawn a teriparatide filing.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.