Sandoz

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FDA reviewing higher dose Hyrimoz biosimilar

By Jane Byrne

The US FDA has accepted a supplemental biologics license application (sBLA) from Sandoz for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar, Hyrimoz.

(Image: Getty/SonerCdem)

Sandoz bows out of US Rituxan biosimilar race

By Ben Hargreaves

After the business was asked by the US FDA to provide more data to secure an approval for its biosimilar, Sandoz decided not to pursue its regulatory filing any further.

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