doi:10.1038/nrd4096AnonymousNature Reviews Drug DiscoveryEMA backs approval of first biosimilar monoclonal antibodies. Nat Rev Drug Discov 12: 568.
According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use (CHMP) released on 6 January 2015 the agency is reviewing two biosimilar applications. One application is for diabetes treatment, human insulin. An insulin glargine...
The approvalof this medicinedeveloped and manufactured by Henlius, is a significant milestone for both companies. Zercepac® is the first monoclonal antibody (mAb), and third biosimilar, launched by Accord inEurope, and it is the first mAb developed by Henlius to ...
DRUG approvalRESEARCHBIOLOGICAL productsRESEARCH methodologyMEDICAL cooperationEVALUATION researchCOMPARATIVE studiesThis paper published with several formatting errors. They have been corrected and the paper has re-published.doi:10.1007/s11606-019-05408-6Emily H. Jung...