IGBA seeks framework waiving bridging trials

 
• By Aidan Fry
  
Generate a summary of this article
Listen to this article
Beta

A new international regulatory framework for waiving biosimilar bridging studies has been proposed by the International Generic and Biosimilar Medicines Association (IGBA) in comments submitted to a US Food and Drug Administration (FDA) docket on facilitating competition and innovation in the biological products marketplace. This would allow such studies to be waived “in specific circumstances, based on core scientific and regulatory principles established for current products”. The IGBA’s call for a framework came in response to the FDA having asked for comments on what additional steps the agency could take “to facilitate multinational development programs that may include non-US-licensed comparators, to help support development of biosimilar products?” The FDA has invited comments via docket FDA-2018-N-2689 following a public hearing on biosimilar competition held in early September (Generics bulletin, 14 September 2018, page 8).

A new international regulatory framework for waiving biosimilar bridging studies has been proposed by the International Generic and Biosimilar Medicines Association (IGBA) in comments submitted to a US Food and Drug Administration (FDA) docket on facilitating competition and innovation in the biological products marketplace. This would allow such studies to be waived “in specific circumstances, based on core scientific and regulatory principles established for current products”. The IGBA’s call for a framework came in response to the FDA having asked for comments on what additional steps the agency could take “to facilitate multinational development programs that may include non-US-licensed comparators, to help support development of biosimilar products?” The FDA has invited comments via docket FDA-2018-N-2689 following a public hearing on biosimilar competition held in early September (Generics bulletin, 14 September 2018, page 8).

At present, the IGBA observes in a reflection paper submitted to the docket, biosimilar sponsors using a foreign reference drug...

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 Regulation

UK Invests £28m In NHS AI, But Industry Says Procurement And Training Will Determine Success - C11

 
• 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 - C10

 
• 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.

Test Regulatory Recap: Ireland To See Earlier Off-Patent Medicines Launches As A State Deal Passes

 
• By Urtė Fultinavičiūtė and Reed Miller

Also, Latest News From Europe, Canada, Saudi Arabia, Finland, China, And The US

Sawai Outlook Improves But Japanese Generics Continue To Suffer Under NHI Price Cuts

 
• By Chloe Kent

Japanese generics giant Sawai appears to be turning a corner, but the impact of National Health Insurance pricing revisions continues to hold the firm – and the rest of the country’s generics industry – back.

More from Policy & Regulation

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-Policy&Regulation-Free: Article with different widgets

Emerging CRISPR innovations, shifting regulatory landscapes, and rising partnerships are accelerating a paradigm shift in biotech pipelines

Overseas API Manufacturing Identified As Key Vulnerability In US Supply Chain

After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.