Four Biosimilar Pegfilgrastims Under EU Review After Sandoz Re-Submits Zioxtenzo
The EMA’s scientific committee, the CHMP, now has four biosimilar versions of Amgen’s neutropenia drug Neulasta (pegfilgrastim) under review, after Sandoz re-submitted its product at the end of October.
You may also be interested in...
Neulasta Is 4-0 Versus Biosimilars Now That Mylan Has A CRL From FDA
FDA issued a complete response letter for Mylan's application for a biosimilar version of Amgen's Neulasta. However, Mylan said the CRL does not change its US launch expectations, targeted for late 2018 or early 2019.
Cinfa Banks On ‘Multi-Layered’ Scientific Advice As It Files For EU Pegfilgrastim Biosimilar Review
Cinfa Biotech is hoping that the advice it received from the EU regulators during the development of its pegfilgrastim biosimilar will help it succeed where others have failed.
More Questions As Biocon Pulls EU Filings For Two Biosimilars
Biocon and partner Mylan have withdrawn the European application for their biosimilar trastuzumab and pegfilgrastim in the backdrop of compliance blips at Biocon’s Indian site, raising critical questions on how soon things can be set right in an increasingly competitive scenario.