More Articles

Pharmacoeconomic modelling of biosimilars in the US Biosimilars/Research | Posted 18/09/2015

There are many challenges and uncertainties associated with the introduction of biosimilars to the US. To try and address these, authors from the Partnership for Health Analytic Research developed...

Biosimilars applications under review by EMA – August 2015 Biosimilars/General | Posted 18/09/2015

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval...

Mylan sued over generic prostate cancer drug Generics/News | Posted 18/09/2015

Generics giant Mylan announced on 18 August 2015 that the company was being sued by BTG International, Janssen Biotech, Janssen Oncology and Janssen Research & Development in connection with th...

Comments on FDA’s guidance on naming biologicals Biosimilars/General | Posted 11/09/2015

The US Food and Drug Administration (FDA) issued a draft guidance on the non-proprietary naming of biological products on 27 August 2015 [1], but not everyone is happy with the proposals made by th...

Biosimilar etanercept approved in South Korea Biosimilars/News | Posted 11/09/2015

US pharma giant Merck and South Korean biosimilars maker Samsung Bioepis announced on 8 September 2015 the approval of their biosimilar etanercept product Brenzys by the Ministry of Food and Drug S...

Pivotal clinical trials for infliximab biosimilars Reports | Posted 11/09/2015

Biosimilars of Johnson & Johnson’s blockbuster arthritis drug Remicade (infliximab), a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α), are currently under development.

Observational study shows switching to generic olanzapine safe Generics/Research | Posted 11/09/2015

A retrospective, observational study carried out by researchers from The University of Auckland, New Zealand (NZ) found no adverse health outcomes when patients switched between generic and brand-n...

Etanar as effective as adalimumab and infliximab in rheumatoid arthritis Biosimilars/Research | Posted 11/09/2015

A study of Etanar – an etanercept similar biotherapeutic product – has shown that it is as effective as adalimumab and infliximab in a cohort of patients with rheumatoid arthritis in a real-life se...