1. Generics Bulletin
  2. >>Products
  3. >>Biosimilars

FDA Warns Over Denigrating Biosimilars

Draft Guidance Seeks To Clamp Down On Efforts To Hinder Uptake

 
• By Derrick Gingery

The guidance states that promotion creating an impression that differences are clinically meaningful when the US FDA has said they are not could be judged misleading.

Advertising
The FDA said accurate information comparing a biosimilar and its reference product could be considered misleading if offered in the wrong context • Source: Shutterstock

US Food and Drug Administration officials have offered a clear warning against suggesting biosimilars are inferior or different from their reference products in promotional campaigns, indicating in new draft guidance that the statements likely would be misleading.

The draft guidance released on 3 February offers considerations for reference biologic and biosimilar sponsors when designing promotional labeling...

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 Biosimilars

Amgen Welcomes Evolving Biosimilar Guidelines As Competitive Advantage

 
• By Dean Rudge

Amgen sees potential regulatory shifts toward streamlined biosimilar approvals as favorable, citing its strength in developing high-quality products.

Kashiv Joins Forces With MS Pharma In MENA For Omalizumab

 
• By Dave Wallace

Kashiv BioSciences has struck a deal with MS Pharma to market its omalizumab biosimilar rival to Xolair in the MENA region.

Civica Pairs With Fresenius Kabi To Supply Stelara Biosimilar

 
• By Dave Wallace

US non-profit Civica has announced a partnership with Fresenius Kabi to supply a Stelara rival, revealing pricing details for its exclusive unbranded version of Kabi’s Otulfi biosimilar that will be available from the start of next year.

Sandoz Streamlines More Trials As First-Half Biosimilars Sales Hit $1.5bn

 
• By Dave Wallace

Sandoz has revealed plans to streamline more biosimilar trials amid evolving regulatory moves towards minimizing the need for comparative efficacy studies. The disclosure was just one of many pipeline and portfolio updates provided as the firm delivered positive first-half results.

More from Products

Generic Entresto Floods US Market Following MSN Patent Victory

 
• By Dean Rudge

As many as ten generic versions of Novartis’ blockbuster heart failure drug Entresto (sacubitril/valsartan) have begun entering the US market following recent key legal victories by MSN Laboratories.

Civica Pairs With Fresenius Kabi To Supply Stelara Biosimilar

 
• By Dave Wallace

US non-profit Civica has announced a partnership with Fresenius Kabi to supply a Stelara rival, revealing pricing details for its exclusive unbranded version of Kabi’s Otulfi biosimilar that will be available from the start of next year.

Sandoz Streamlines More Trials As First-Half Biosimilars Sales Hit $1.5bn

 
• By Dave Wallace

Sandoz has revealed plans to streamline more biosimilar trials amid evolving regulatory moves towards minimizing the need for comparative efficacy studies. The disclosure was just one of many pipeline and portfolio updates provided as the firm delivered positive first-half results.