News
EMA approves first monoclonal antibody biosimilars
2013-10-23 The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced on 28 June 2013 that it had recommended granting of marketing… Read More »
Ranbaxy faces lawsuit in India
2013-10-21 An Indian lawyer has filed a lawsuit asking the Indian Supreme Court to investigate Ranbaxy Laboratories (Ranbaxy), its executives and Indian drug control officers, as… Read More »
Erythropoietin biosimilars in bone marrow transplantation and stem cell donation
2013-10-18 Combination therapy with granulocyte colony-stimulating factor (G-CSF) and erythropoietin (EPO) has been used with the aim of accelerating the recovery of red blood cells following… Read More »
Infliximab biosimilar comparable to Remicade
2013-10-16 South Korean biotechnology company Celltrion presented results of its extended trials for its biosimilar infliximab candidate Remsima (CT-P13) at the European League Against Rheumatism (EULAR)… Read More »
International harmonization for biosimilars
2013-10-14 What is the possibility of international harmonization for biosimilars? EMA Head of Biologicals Dr Peter Richardson and Amgen Director of Value, Access and Policy Mr… Read More »
Enhancing prescribing efficiency in the Republic of Srpska
2013-10-11 It has been claimed that countries with smaller populations have difficulties obtaining considerable price reductions for generics. However, evidence from the Republic of Srpska, which… Read More »
Biosimilar monoclonal antibodies and pharmacovigilance in Europe
2013-10-09 EMA Head of Biologicals Dr Peter Richardson and Amgen Director of Value, Access and Policy Mr Thomas Moore speak to BioCentury about biosimilar monoclonal antibodies… Read More »
Robust data for biosimilar trastuzumab programmes presented
2013-10-07 Celltrion and Pfizer have presented robust data from their respective biosimilar trastuzumab programmes at the ASCO (American Society of Clinical Oncology) 2013 Annual Meeting held… Read More »
Possibility of substitution of biosimilars in Europe
2013-10-04 To date, 14 biosimilars within the product classes of human growth hormone (1), granulocyte colony-stimulating factor (8) and erythropoietin (5) have been approved in Europe.… Read More »
Use of G-CSF biosimilars for reduction of fever
2013-10-02 The American Society of Hematology, the British Society of Haematology, the European Society of Hematology and the European Group of Bone Marrow Transplantation all recommend… Read More »
