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

Biosimilars: US FDA Developing Guidance For First Interchangeable Exclusivity

First Interchangeable Biosimilar Approved Is Entitled To One Year Of Exclusivity

 
• By Derrick Gingery

The first biosimilar with interchangeability status compared to its reference will be entitled to one year of exclusivity, a largely overlooked advantage in the early days of the US biosimilar market.

Railway tracks with switches and interchanges at a main line in Germany with geometrical structures black and white
First interchangeable exclusivity guidance is one of several the FDA is writing in the interchangeability area • Source: Shutterstock

US Food and Drug Administration officials are moving to set biosimilar interchangeability exclusivity policy as some products seeking the designation may be approaching the approval stage.

The first interchangeable biosimilar approved is entitled to one year of exclusivity per the Biologics Price Competition and Innovation Act...

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

Apotex Follows Biocon With Canadian Biosimilar Aflibercept Launch

 
• By Dean Rudge

Apotex is marking a “key milestone,” introducing its first ophthalmic biosimilar and its fourth biosimilar since 2016 in its native Canada, with the approval and launch of a biosimilar to Eylea 2mg.

European Industry Calls For Support As It Juggles Multiple Challenges

 
• By Dave Wallace

At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.

Bio Usawa To Market Formycon’s Lucentis Biosimilar In Sub-Saharan Africa

 
• By Urtė Fultinavičiūtė

Bio Usawa’s CEO said access to advanced biologics should not be a privilege of geography or income, as it prepares to launch Formycon/Bioeq’s ranibizumab biosimilar in Africa.

Sandoz Starts Construction On $440m Slovenian Biosimilars Plant

 
• By Dave Wallace

Sandoz has begun constructing a major biosimilars manufacturing facility in Slovenia that is set to become operational in 2028. A $440m investment in the project adds to local biosimilars initiatives that together total over $1bn, helping Sandoz to move out of the shadow of former parent Novartis.

More from Products

US Federal Circuit Says It Will Not Rehear Viatris Invega Trinza Infringement Ruling

 
• By Dean Rudge

The US Federal Circuit’s March 2025 decision affirming a lower court’s determination on both induced infringement and non-obviousness concerning a key patent shielding Janssen’s Invega Trinza (paliperidone palmitate) long-acting injectable is set to stand – for now.

FDA Will Not Pull Teva And MSN Hetlioz ANDAs, Finds No ‘Serious Discrepancies’

 
• By Dean Rudge

The FDA has concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements, and that there was no “mistake” or untrue statement in the original ANDA approvals, as it denied Vanda’s citizen petition.

Bio Usawa To Market Formycon’s Lucentis Biosimilar In Sub-Saharan Africa

 
• By Urtė Fultinavičiūtė

Bio Usawa’s CEO said access to advanced biologics should not be a privilege of geography or income, as it prepares to launch Formycon/Bioeq’s ranibizumab biosimilar in Africa.