AAM And Medicines For Europe Urge Transatlantic Framework For Complex Generics

Regulatory Convergence Across The Atlantic Could Help Improve Complex Generic Development

A proposed joint framework for complex generic development between the US and EU could reduce study duplications by eliminating the need to use locally approved comparators, a move that has been embraced by other regions and international organizations.

US and EU flags on cogs in machine
A joint development program is a shared objective of the EU and US health authorities • Source: Shutterstock

European and US generics and biosimilars organizations Medicines for Europe and the Association for Accessible Medicines have released a joint statement urging a common EU and US development program for complex generics, as the transatlantic political body EU-US Trade and Technology Council gathered to discuss key trade and economic issues in Washington DC on 30 January.

In the statement released ahead of the 5th TTC meeting, AAM and Medicines for Europe called for both regions...

More from Generics

Welch Heads Up Par Ahead Of Planned Spin-Off After Endo-Mallinckrodt Merger

 
• By 

As Endo and Mallinckrodt continue to work towards consummating the merger they announced earlier this year, the pair have revealed further organizational details of their combined generics and sterile injectables business, which is set to be spun off after the merger is complete.

Generic Drug Office’s Policy Staff Returning To US FDA

 

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

Stelara Biosimilar Sees Stada’s Specialty Sales Start Strong In Q1

 
• By 

Stada’s Specialty division was boosted by the firm’s launch last year of a European Stelara biosimilar, even as generics growth remained muted in Q1.

Lupin Concedes To Wakix IP With 2030 Launch Date Agreement

 
• By 

Ahead of a bench trial beginning in February 2026, Lupin has become the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster by the end of the decade.

More from Products

Generic Drug Office’s Policy Staff Returning To US FDA

 

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

Stelara Biosimilar Sees Stada’s Specialty Sales Start Strong In Q1

 
• By 

Stada’s Specialty division was boosted by the firm’s launch last year of a European Stelara biosimilar, even as generics growth remained muted in Q1.

Formycon Snatches Brazilian Approval For Lucentis Biosimilar

 

Formycon is preparing to start a new era – entering Latin America with its ranibizumab biosimilar, which is expected to be a “good contributor” to the firm’s finances.