Sandoz’s High-Concentration Humira Biosimilar Lands On FDA’s Desk
SBLA Follows EMA Accepting Proposed Biosimilar For Filing In June
Sandoz has named its three most promising upcoming biosimilar launches, ahead of filing its proposed high-concentration version of adalimumab with the US Food and Drug Administration.
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Samsung Bioepis and Organon have broken new ground for Humira biosimilars in the US after receiving the first FDA approval for a higher-strength 100mg/ml adalimumab biosimilar.
Looking back over the second quarter of 2022, Generics Bulletin executive editor Dave Wallace picks out highlights from April to June that include multiple first generic and biosimilar launches, some noteworthy executive moves, further preparation for biosimilar competition to Humira in the US, and a major European industry conference.