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IGBA Wants A Harmonized And Streamlined Global Framework

 
• By Dave Wallace

In the first of three exclusive interviews with IGBA secretary general Suzette Kox and chair Jim Keon, Kox provides the latest update on global regulatory harmonization efforts.

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The IGBA’s Secretary General And Chair Give Us The Latest On Global Issues Affecting The Generics And Biosimilars Industries • Source: Shutterstock

As the global industry association for generics and biosimilars companies, the International Generic and Biosimilar medicines Association (IGBA) is at the center of the latest developments for off-patent drugs.

Under the tenure of current chair Jim Keon – who is also president of the Canadian Generic Pharmaceutical Association (CGPA)...

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Sandoz Scores Regional First With EU Launch Of Autoinjectable Stelara Rival

 
• By Adam Zamecnik

Doubling down on the launch of its Stelara biosimilar Pyzchiva in Europe last year, Sandoz has just released an autoinjectable version of the drug, with the aim to offer a more convenient option for ustekinumab patients.

Sun On Leqselvi US Launch Ahead, MFN Pricing And Pipeline Changes

 
• By Anju Ghangurde

Sun readies US debut of Leqselvi for alopecia areata, while PD-L1 inhibitor Unloxcyt is in the line up once the Checkpoint Therapeutics deal is completed. Management also discusses limited clarity on President Trump’s most favored nation pricing push, pipeline tweaks and M&A outlook.

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?

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.

More from Policy & Regulation

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.

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.

Regulatory Recap: ICH To Determine The Future Of Biosimilar Comparative Efficacy Studies

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.