Samsung Bioepis’s Biosimilar Trastuzumab First To Take On Roche’s Herceptin In EU
Executive Summary
Samsung Bioepis’s Ontruzant is likely to be the first biosimilar to take on Roche’s Herceptin in the EU market after it was recommended for marketing authorization by the EMA’s CHMP on Sept 15.
You may also be interested in...
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Biocon and partner Mylan have withdrawn the European application for their biosimilar trastuzumab and pegfilgrastim in the backdrop of compliance blips at Biocon’s Indian site, raising critical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.
EU Adopts New Rules On UK-Wide Approvals For Novel Drugs
Having been passed by the European Parliament and now the Council of the EU, new legislation will clear up some of the issues raised by Brexit relating to trade in medicines between Great Britain and Northern Ireland.
UK In Major Move To Boost Commercial Clinical Trials & Improve Life Sciences Environment
The publication of two major reports has led the UK government to announce a £650m “Life Sci for Growth” package to bolster the life sciences sector.