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A biosimilar is a copy of a biologic drug such as trastuzumab, shown to be as safe and effective as the original once its patent expires, usually at a lower price.
A biosimilar is a copy of a biologic drug, such as trastuzumab, shown to match the original in safety and effectiveness once its patent has expired, and usually sold at a lower price. Approval runs through abbreviated pathways, the FDA 351(k) route and the EMA equivalent, on analytical, pharmacokinetic and comparative clinical evidence. Oncology biosimilars of trastuzumab, bevacizumab, rituximab and pegfilgrastim now dominate volume, and interchangeability designations and WHO prequalification widen access. Readers meet it on the trastuzumab biosimilars page and in the drug pricing, regulatory divergence and global access bottlenecks. Ideas on default substitution at the pharmacy, dropping switching studies, and a flat fee for giving Part B drugs depend on it.
Backbone ribbon from PDB 1N8Z. RCSB PDB 1N8Z. The ribbon widens where the chain is folded into a regular pattern and narrows where it is a loose loop.
Showing the molecule this term concerns: Trastuzumab biosimilars.
Shares Supplementary protection certificate (EU), EU data and market protection (8+2+1), US regulatory exclusivity periods, Hatch-Waxman Act 1984.
Shares Organon & Co., Intas Pharmaceuticals (Accord Healthcare), Viatris, Biocon.
Shares Pay a flat fee for giving a Part B drug instead of 6% of its price, Biologics Price Competition and Innovation Act 2010, Oncology drug pricing and price transparency, Hatch-Waxman Act 1984.
Shares US regulatory exclusivity periods, Oncology drug pricing and price transparency, Hatch-Waxman Act 1984, WHO Essential Medicines List for cancer.
Shares Biocon, Biocon Biologics, Trastuzumab biosimilars, Prices and value.
Shares US regulatory exclusivity periods, Oncology drug pricing and price transparency, Hatch-Waxman Act 1984, WHO Essential Medicines List for cancer.
Shares Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Regulatory divergence between regions, Prices and value, Trastuzumab.
Shares US regulatory exclusivity periods, Hatch-Waxman Act 1984, Inflation Reduction Act 2022: Medicare drug price negotiation, Prices and value.