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EMA product updates - 17th March

Mar 17, 2025
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We've decided to move this post to Mondays instead of Fridays. But will continue to capture important changes.

The latest updates on EMA product registrations in the last week include

With the launch of Zefylti, there are now 8 different biosimilars for Neupogen in the markets, a competitive space!

Paxneury is an interesting new generic in the market, the only one for Intuniv in the EU. While there are a few generics in the US registered and found in PharmaFootpath, Paxneury is the first EU registered generic.

Uzpruvo is a Stelara biosimilar, and the majority of others also have a vial presentation for intravenous use. Stada has now expanded their approved presentations to include this also.

Quetiapine extended release is being reported as in shortage in a number of individual EU countries, and now the EMA has recognised this in their shortages tracking. The issue appears to be that the majority of these extended release products are from the same manufacturer, and production issues there are causing issues in multiple markets.