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