Biosimilars/Research
The future of nanomedicines – nanosimilars
First there were generics, then came biosimilars and soon the European Medicines Agency (EMA) is anticipating the first nanosimilars, or similar versions of originator nanomedicines.
Regulation of similar biotherapeutic products in Latin America
Regulation of similar biotherapeutic products (SBPs) in Latin America varies widely among different countries and, although many countries have yet to introduce guidance for biosimilars, the region is moving towards increasing standards of regulation for these products [1, 2].
Positive phase III data for Epirus infliximab biosimilar
US-based Epirus Biopharmaceuticals (Epirus) announced on 28 August 2013 that its biosimilar infliximab candidate had demonstrated ‘clinical comparability’ to Remicade as measured by the ACR20 response in severe rheumatoid arthritis patients.
Assessment of efficacy and safety of biosimilars in rheumatology
During the last decade, the availability of biological therapies has revolutionized the treatment of rheumatoid arthritis. Biologicals, unlike small-molecule chemical drugs, are extremely complex molecules, making producing biosimilars far from a simple process.
Cost savings from use of biosimilars in rheumatology
The treatment of rheumatoid arthritis provides a clear argument in favour of developing biosimilars and the need to collect sufficient pharmacological data to validate their bioequivalence and interchangeability.
Infliximab biosimilar comparable to Remicade
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) 2013 Conference, which was held in Madrid, Spain on 12–15 June 2013.
Erythropoietin biosimilars in bone marrow transplantation and stem cell donation
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 autologous bone marrow transplantation [1]. Previous studies have shown, however, that this practice has no significant effect on erythroid recovery and transfusional requirements.
Robust data for biosimilar trastuzumab programmes presented
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 on 31 May to 4 June 2013.
Use of G-CSF biosimilars for reduction of fever
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 the use of granulocyte colony-stimulating factor (G-CSF) after transplant in order to reduce the time to neutrophil recovery and the number of days with fever.
Positive post-marketing data for biosimilar epoetin
Injectable generics specialist, Hospira, presented results from a post-marketing study of the company’s European biosimilar epoetin (Retacrit) on 3 June 2013 at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) held in Chicago, USA.
