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

FDA And FTC Join Forces On Biosimilars

Teaming Up To Eliminate Barriers To Biosimilar Competition

 
• By Brenda Sandburg

Two agencies to take action against false or misleading communications about biosimilars, impediments to sampling, and anticompetitive patent settlement agreements; to hold public workshop in March.

Conceptual business illustration with the words anti-competitive practices
FDA and FTC to target anticompetitive behavior that impedes access to biosimilars • Source: Shutterstock

Biologic manufacturers could face a wave of enforcement actions against behavior that impedes the marketing of biosimilars as the US Food and Drug Administration and Federal Trade Commission are teaming up to promote competition in biologics markets.

The two agencies issued a 3 February joint statement in which they committed to strengthening efforts to curtail and...

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

Medicines UK’s Samuels: Off-Patent Drugs Are Finally Gov’s Priority But The Picture Still ‘Nuanced’

 
• By Urtė Fultinavičiūtė

The importance of generic and biosimilar medicines is being recognized by the UK government for the first time. But, as Medicines UK’s CEO Mark Samuels tells Generics Bulletin, companies are still facing multiple hurdles in the market.

BC Partners Bids For Biogaran Buyout – But Will It Face French Pushback?

 
• By Dave Wallace

Private equity firm BC Partners has revealed that it is in exclusive negotiations to acquire Servier’s French generics and biosimilars business Biogaran. But with France’s government having expressed opposition to the sale, could there be strings attached?

Roche Braces For Late 2026 Biosimilar Wave

 
• By Dean Rudge

Roche expects biosimilars to Perjeta and Xolair by the end of 2026, marking a key inflection point for two of its major franchises. Shanghai Henlius Biotech leads development for pertuzumab, while Celltrion is positioned as the frontrunner for omalizumab.

Sandoz Strikes $300m Deal With Just-Evotec For French Biosimilars Site

 
• By Dave Wallace

Sandoz has made yet another major move to further bolster its booming biosimilars business, striking a $300m deal to acquire outright a French development and manufacturing facility from existing biosimilars partner Just-Evotec Biologics.

More from Products

Generics Bulletin’s Top 50 Ranking For 2025

 
• By Dave Wallace

This article compiles all of the data from Generics Bulletin’s 2025 ranking of the Top 50 firms across the generics and biosimilars industry, including additional details of how the various financial figures stack up.

The Generics Bulletin Top 50, Part Three: New Firms Enter Global Grouping

 
• By Dave Wallace

In the third instalment of this year’s Generics Bulletin Top 50, we reveal which firms have entered the ranking for the first time.

Latest EMA Biosimilar Nods Come For Henlius, Alteogen And Biocon

 
• By Dave Wallace

Denosumab, aflibercept and ustekinumab biosimilars received positive opinions from the EMA’s CHMP at its meeting in July, along with an Opsumit generic from Accord.