1. Generics Bulletin
  2. >>Policy & Regulation
  3. >>Regulation

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for biosimilars has once again flared up – as a result of a recent decision by Health Canada and newly-published draft guidance from the US Food and Drug Administration (FDA) – and the International Generic and Biosimilar medicines Association (IGBA) has not shied away from weighing in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

Following Health Canada’s recent decision to not add suffixes to non-proprietary names for biologics, including biosimilars – leaving the US as the only major territory to operate such a convention (Also see "Canadian Decision On Biological Names Leaves US As The Outlier" - Generics Bulletin, 19 February, 2019.) – the IGBA called on the FDA to reconsider the use of a suffix-based naming system

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

UK-India FTA Could Offer ‘Significant Benefits’ For Generics And Biosimilars

 
• By Dave Wallace

A free trade agreement struck between the UK and India could over “significant benefits for the generic and biosimilar sectors,” Medicines UK believes. The off-patent industry association has also suggested further avenues for collaboration between the two governments on regulatory pathways and supply security.

US FDA Expands Surprise Foreign Inspections

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Teva And Alvotech Celebrate Interchangeability For US Ustekinumab

 
• By Dave Wallace

The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.

Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By Dave Wallace

As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.

More from Policy & Regulation

Trump Order On Domestic Manufacturing Wins Plaudits From Industry

 
• By Dave Wallace

An executive order from US president Donald Trump aimed at incentivizing domestic manufacturing of critical medicines has been welcomed by the US Association for Accessible Medicines.

Teva And Alvotech Celebrate Interchangeability For US Ustekinumab

 
• By Dave Wallace

The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.

Medicines UK Welcomes NHS England’s Best-Value Biologics Biosimilar Adoption Framework

 
• By Adam Zamecnik

Reflecting on recent initiatives by NHS England and the MHRA, the newly renamed trade body Medicines UK has welcomed efforts in promoting the use of biosimilars in Britain.