Will Companies Be Able to Launch ‘Authorized Biosimilars’ In The Future? Eli Lilly Wants To Know

 
• By Dean Rudge
  
Generate a summary of this article
Listen to this article
Beta

In response to FDA draft guidance reclassifying certain NDA “drugs” as BLA “biologics,” Eli Lilly is asking the FDA to clarify whether regulatory mechanisms exist for biological product sponsors to introduce ‘second versions’ of their innovative biological products.

Twins
Clarity on 'branded biosimilars' will increase biologic competition, Eli Lilly says. • Source: Shutterstock

The US Food and Drug Administration (FDA) is being urged to clarify the “applicable regulatory mechanisms” for companies to introduce “second versions,” or “branded biosimilars,” of their own reference products, in light of the agency’s intention to transition the regulation of certain new drug applications (NDAs), including insulins, to regulation as biologic license applications (BLAs).

Insulins specialist Eli Lilly made the request in its feedback to the agency’s draft guidance, The ‘Deemed to be a...

Generics Bulletin Podcast

Stay ahead of every shift in generics and biosimilars.

Generics Bulletin brings you the latest updates that matter for the off-patent industry.

SpotifyApple PodcastsWebsite

More from Biosimilars

UK Invests £28m In NHS AI, But Industry Says Procurement And Training Will Determine Success - C7

 
• By Reed Miller

The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.

UK Invests £28m In NHS AI, But Industry Says Procurement And Training Will Determine Success - C6

 
• By Reed Miller

The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.

US Biosimilars

An abbreviated licensure pathway for biologics was created by the 2009 Biologics Price Competition and Innovation Act. Biologics demonstrated to be biosimilar to or interchangeable with FDA-approved products can use the 351(k) biologics license application pathway. Biosimilars BLAs submitted under the 351(k) pathway have a 12 month user fee goal for FDA action. Updated weekly.

Top 10 Drugs Q1 2026: New Sheriff In Town As Mounjaro Unseats Keytruda - Clone - Clone

Mounjaro, Eliquis, and Darzalex buck the Q1 trend to make gains

More from Products

For Generics, A Victory Lap – And A Warning – On Drug Shortages

Avoiding disaster at the beginning of the pandemic and offering a pro-active supply chain blueprint should position the generics industry well for an onshoring debate in Congress, but a look back at March 2020 is a reminder that even small policy shifts can have a big impact.

GB-Free-Company-The Secret to Walking More: It’s Not Counting Steps

We’ve all been told that walking 10,000 steps a day is the magic number for better health. But what if the real secret to walking more isn’t about counting steps at all? In this article, we explore how focusing on motivation, environment, and mindset can help you build a walking habit that lasts.

Biocon And Teva Sign Up To Biosimilars Forum

Teva and Biocon Biologics have become the latest firms to sign up to the Biosimilars Forum industry association in the US.