1. Generics Bulletin

IGBA Still Sees A Path To Change FDA’s Mind On Biologic Suffixes

 
• By Dave Wallace

In the second of three exclusive interviews with IGBA secretary general Suzette Kox and chair Jim Keon, Kox provides the latest update on worldwide issues around biosimilars, particularly naming conventions.

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

In recent months, a global debate around naming conventions for biosimilars has once again flared up – as a result of a recent decision by Health Canada and newly-published draft guidance from the US Food and Drug Administration (FDA) – and the International Generic and Biosimilar medicines Association (IGBA) has not shied away from weighing in on the controversy.

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?

More from Regulation

More from Policy & Regulation

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
• By Derrick Gingery

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

Henlius And Outlook Move Forward With Ophthalmic Bevacizumab

 
• By Dave Wallace

Henlius has reported progress in its development of a bevacizumab product for treating ophthalmic diseases, with its Essex-partnered HLX04-O candidate meeting its primary endpoint in a Phase III trial. Meanwhile, Outlook Therapeutics has taken another shot at getting its own ophthalmic bevacizumab approved in the US after resubmitting its filing.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.