{"entity":{"id":"biosimilar","kind":"term","name":"Biosimilar","aka":["biosimilars","biosimilar competition","biosimilar uptake","biosimilar versions","biosimilar entry","biosimilar switching"],"tldr":"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.","summary":"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.","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Biosimilar","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/Biosimilar"}],"tags":[],"related":["bpcia","hatch-waxman","us-regulatory-exclusivity","eu-data-exclusivity","spc","china-vbp-nrdl","eu-pharma-package","inflation-reduction-act"],"cancers":["breast-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["trastuzumab-biosimilars","trastuzumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"category":"Regulation & policy"},"route":"/terms/biosimilar/","neighbours":{"term":[{"id":"bpcia","kind":"term","name":"Biologics Price Competition and Innovation Act 2010","route":"/terms/bpcia/"},{"id":"china-vbp-nrdl","kind":"term","name":"China National Reimbursement Drug List negotiation and volume-based procurement","route":"/terms/china-vbp-nrdl/"},{"id":"eu-data-exclusivity","kind":"term","name":"EU data and market protection (8+2+1)","route":"/terms/eu-data-exclusivity/"},{"id":"eu-pharma-package","kind":"term","name":"EU pharmaceutical package reform (2023 proposal)","route":"/terms/eu-pharma-package/"},{"id":"hatch-waxman","kind":"term","name":"Hatch-Waxman Act 1984","route":"/terms/hatch-waxman/"},{"id":"inflation-reduction-act","kind":"term","name":"Inflation Reduction Act 2022: Medicare drug price negotiation","route":"/terms/inflation-reduction-act/"},{"id":"drug-price-transparency","kind":"term","name":"Oncology drug pricing and price transparency","route":"/terms/drug-price-transparency/"},{"id":"spc","kind":"term","name":"Supplementary protection certificate (EU)","route":"/terms/spc/"},{"id":"us-regulatory-exclusivity","kind":"term","name":"US regulatory exclusivity periods","route":"/terms/us-regulatory-exclusivity/"},{"id":"who-essential-medicines","kind":"term","name":"WHO Essential Medicines List for cancer","route":"/terms/who-essential-medicines/"}],"cancer":[{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"}],"drug":[{"id":"trastuzumab","kind":"drug","name":"Trastuzumab","route":"/drugs/trastuzumab/"},{"id":"trastuzumab-biosimilars","kind":"drug","name":"Trastuzumab biosimilars","route":"/drugs/trastuzumab-biosimilars/"}],"bottleneck":[{"id":"b-global-access","kind":"bottleneck","name":"Most of the world has almost no cancer care","route":"/bottlenecks/b-global-access/"},{"id":"b-drug-pricing","kind":"bottleneck","name":"Prices and value","route":"/bottlenecks/b-drug-pricing/"},{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"}],"idea":[{"id":"idea-cost-interchangeable-oncology-biosimilars","kind":"idea","name":"Drop the extra switching studies for interchangeable oncology biosimilars","route":"/ideas/idea-cost-interchangeable-oncology-biosimilars/"},{"id":"idea-cost-biosimilar-default-substitution","kind":"idea","name":"Make the biosimilar the default at the pharmacy for trastuzumab, bevacizumab and rituximab","route":"/ideas/idea-cost-biosimilar-default-substitution/"},{"id":"idea-cost-asp-flat-fee","kind":"idea","name":"Pay a flat fee for giving a Part B drug instead of 6% of its price","route":"/ideas/idea-cost-asp-flat-fee/"}],"technology":[{"id":"g-csf-growth-factors","kind":"technology","name":"Growth factors: G-CSF and febrile neutropenia prevention","route":"/technologies/g-csf-growth-factors/"}],"company":[{"id":"biocon","kind":"company","name":"Biocon","route":"/companies/biocon/"},{"id":"biocon-biologics","kind":"company","name":"Biocon Biologics","route":"/companies/biocon-biologics/"},{"id":"dr-reddys","kind":"company","name":"Dr. Reddy's Laboratories","route":"/companies/dr-reddys/"},{"id":"hetero","kind":"company","name":"Hetero Drugs","route":"/companies/hetero/"},{"id":"intas","kind":"company","name":"Intas Pharmaceuticals (Accord Healthcare)","route":"/companies/intas/"},{"id":"mabion","kind":"company","name":"Mabion","route":"/companies/mabion/"},{"id":"organon","kind":"company","name":"Organon & Co.","route":"/companies/organon/"},{"id":"viatris","kind":"company","name":"Viatris","route":"/companies/viatris/"},{"id":"zhejiang-hisun","kind":"company","name":"Zhejiang Hisun Pharmaceutical","route":"/companies/zhejiang-hisun/"}],"roadmap":[{"id":"global-access-roadmap","kind":"roadmap","name":"Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation","route":"/roadmaps/global-access-roadmap/"}]}}