While removal of the biologics exclusivity provision from the United States-Mexico-Canada Agreement (USMCA) was the most significant change to the trade pact for the biopharma industry, there were several other revisions that may allow speedier entry of generic drugs.
Generic 'Rewards' Added To, 'Evergreening' Requirements Dropped From North American Trade Deal
USMCA is looking more and more like a win for generic firms, who hope it will be template for future trade agreements.
More from Generics
• By
Teva was forced to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March after the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?
• By
Multiple sources, including former Acting FDA Commissioner Janet Woodcock, told the Pink Sheet that industry is quietly complaining about FDA work delays and they expect the problem will worsen.
• By
The FDA generic drugs team’s first public workshop of the second Trump Administration ended with a request that industry amplify the value it finds from public engagement.
• By
Unofficial January results showed the US FDA continued to issue full and tentative ANDA approvals in line with previous months, but recent layoffs may not help the agency maintain that pace.
More from Biosimilars & Generics
• By
Multiple sources, including former Acting FDA Commissioner Janet Woodcock, told the Pink Sheet that industry is quietly complaining about FDA work delays and they expect the problem will worsen.
• By
Roche is in the crosshairs of the Belgian Competition Authority for allegedly delaying the entry of rituximab and trastuzumab biosimilars between 2017 and 2020, after the BCA sent the firm a statement of objections over “exclusionary practices.”
• By
The FDA generic drugs team’s first public workshop of the second Trump Administration ended with a request that industry amplify the value it finds from public engagement.