The legislative proposal would make first-filer exclusivity function similar to the competitive generic therapy program, allowing additional approvals if the commercial launch is delayed.
The Biden administration is attempting to revive a proposal that it argues would speed approvals of ANDAs and drive “significant cost savings” but that generic firms worry would upend their business model and erode one their most valuable incentives.
Included among the legislative proposals in the US Food and Drug Administration’s fiscal year 2023 budget request congressional justification,...
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.
Hot on the heels of a recent alliance in Italy, biosimilars developer mAbxience has struck another deal – this time partnering with Corapharm in south-east Europe.
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.
