With healthcare costs rising and biologics driving a large portion of drug spend, the next wave of biosimilar launches promises to reshape the U.S. pharmaceutical market in profound ways, including reduced prices for close...more
FDA approves Omylco® (omalizumab), first biosimilar of Xolair®.
After Q1, FDA and EMA on track for a record number of biosimilar authorizations in 2025....more
The U.S. stands at a crossroads in light of rising drug prices and it is unclear what the future will hold in answer to the rising drug costs. Biologic medicines have rapidly expanded available treatment options and accounted...more
2/19/2025
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Biosimilars ,
BPCIA ,
Clinical Trials ,
Competition ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
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Healthcare ,
Intellectual Property Protection ,
Medicare ,
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Regulatory Requirements
FDA and EMA both approve additional biosimilar versions of Humira® (adalimumab).
FDA also approves its third biosimilar version of Neupogen® (filgrastim). ...more
FDA and EMA both approve first biosimilar version of Lucentis® (ranbizumab).
FDA has approved only two biosimilars in 2021 after only approving three in 2020.
EMA approves four more Avastin® (bevacizumab) biosimilars,...more