Samsung Bioepis And Organon Get First High-Concentration Adalimumab Nod In US
Firms Receive First FDA Approval For Higher-Strength 100mg/ml Humira Biosimilar
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.
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Already approved in the EU, Norway, Iceland, Lichtenstein, the UK, Switzerland, and Canada, Alvotech’s AVT02 high-concentration biosimilar to Humira (adalimumab) will not be greenlit by the USFDA until the Icelandic firm resolved manufacturing deficiencies.
Just-in-time education may be preferred, so patients and providers see it as they are making decisions, OTBB Director Sarah Yim says in an interview.
The European Commission has approved Vegzelma, a bevacizumab biosimilar developed by South Korean biopharma giant Celltrion. Vegzelma joins nine other bevacizumab biosimilar marketing authorization applications approved in the EU, promising to intensify price competition for the critical late-stage cancer treatment.