FDA Approves Sandoz’s Ziextenzo as 24th Biosimilar
The U.S. Food and Drug Administration (FDA) has approved Ziextenzo (pegfilgrastim-bmez), the 24th biosimilar approval in the U.S.
Nivestym, a Biosimilar to Neupogen, Approved by FDA
Pfizer’s Nivestym (filgrastim-aafi) has been approved by FDA for all eligible indications of the reference product.
Biosimilars: From Concept to Reality
Approvals in 2018 brought the total number of U.S. Food and Drug Administration-licensed biosimilars well into the double digits — and more are in the pipeline.
FDA Approves First Biosimilar to Fight Cancer
The U.S. Food and Drug Administration approved Mvasi (bevacizumab-awwb), a biosimilar to Avastin (bevacizumab), the first biosimilar drug to treat cancer.
Mylan’s Ogivri Approved as Biosimilar to Herceptin
Mylan’s Ogivri (trastuzumab-dkst) has been approved by the U.S. Food and Drug Administration as a biosimilar to Genentech’s Herceptin (trastuzumab).
FDA Approves Renflexis, Biosimilar to Remicade
The U.S. Food and Drug Administration has approved Renflexis (infliximababda, Samsung Bioepis), the second biosimilar to Remicade (infliximab, Janssen Biotech).
FDA Approves Sandoz’s Erelzi as Biosimilar to Amgen’s Enbrel
The U.S. Food and Drug Administration has approved Erelzi (etanercept-szzs), the first biosimilar etanercept, for all indications included in the reference product’s label.
CMS Announces Biosimilars Reimbursement Rule
The Centers for Medicare and Medicaid Services issued final rules detailing how it will pay for services provided to Medicare beneficiaries in 2016.
Future Biosimilars Pros and Cons
As biosimilars are introduced into the U.S. market, it remains to be seen whether FDA guidances will ensure their safety and efficacy.
11 Companies Launch Biosimilars Forum
The Biosimilars Forum was launched by 11 of the leading biosimilar developers in the U.S.