1. Generics Bulletin

Stada And Calliditas Celebrate European Nod For Budesonide Hybrid

As Four Generics Also Endorsed By EMA’s CHMP At May Meeting

 
• By Dave Wallace

The EMA’s CHMP has issued a positive opinion for the Kinpeygo budesonide 4mg modified-release hard capsules hybrid medicine developed by Calliditas that will be marketed in Europe by Stada. Meanwhile, four generics from Accord, Fresenius Kabi, Gedeon Richter and Sun have also been endorsed by the committee.

EMA
The EMA’s CHMP issued positive opinions for a hybrid and four generics

Stada and Calliditas have received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use recommending the approval of their Kinpeygo (budesonide) 4mg modified-release hard capsules hybrid medicine referencing Entocort. Typically, the European Commission acts to convert positive CHMP opinions into marketing authorizations within 67 days.

Launched in January in the US as Tarpeyo, the treatment for primary immunoglobulin A nephropathy will be marketed by Stada in the European Economic Area, Switzerland and the UK

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