Rebate Reprieve For Generics And Biosimilars Added To Build Back Better Act

Generics Facing Shortages And Biosimilars Are Now Exempt From Rebate Scheme

The Build Back Better Act has been updated to exempt generics experiencing or at risk of shortage from its planned inflation rebates, as well as biosimilars. But the US Association for Accessible Medicines has called for further changes to the proposed bill to protect off-patent drugs.

Wooden letters on dark background
Select generics and biosimilars have been exempted from Build Back Better's rebate scheme • Source: Alamy

An update to the language of the Biden administration’s proposed Build Back Better Act has been welcomed by the US Association for Accessible Medicines, after biosimilars and certain generic drugs were exempted from its planned inflation rebates – but the organization has still called for further changes to be made to the draft legislation.

The latest version of the bill now states that generic drugs under Medicare Part D that are in shortage can...

More from Policy & Regulation

Snapshot Of India’s Pharma Manufacturing Network Amid ‘Trumponomics’

 

Collating data on the global manufacturing network of leading Indian drug makers, the markets serviced and production hubs for active pharmaceutical ingredients. Will ongoing geopolitical tensions and policy shifts have a bearing on some of these down the line?

Alchem Fined Over Buscopan API Cartel

 
• By 

After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.

Apotex Follows Biocon With Canadian Biosimilar Aflibercept Launch

 
• By 

Apotex is marking a “key milestone,” introducing its first ophthalmic biosimilar and its fourth biosimilar since 2016 in its native Canada, with the approval and launch of a biosimilar to Eylea 2mg.

European Industry Calls For Support As It Juggles Multiple Challenges

 
• By 

At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.

More from Generics Bulletin

Lupin And Zentiva Throw Hat Into The Ring On Biosimilar Cimzia

 
• By 

The announcement by Lupin and Zentiva of a development and commercialization deal on a certolizumab pegol biosimilar candidate has revealed a new potential challenger to Alvotech’s AVT10, previously thought to be the only Cimzia rival in development.

‘Prescription Drugs Are Not Golf Balls’ – Opinions Clash On Patents During FTC/DOJ Listening Session

 

Pro-innovator voices argued that the number of patents asserted in the pharma industry is not too dissimilar to other fields. But should drugs be compared to golf balls?

China’s Qilu Looks To US Hospitals Market With Sagent Injectables Collaboration

 
• By 

Sagent and Qilu will look to enhance access, reduce treatment costs, and strengthen supply chains after striking an alliance for a portfolio of the Chinese firm’s complex injectables.