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EMA accepts applications for pegfilgrastim and trastuzumab biosimilars from Biocon/Mylan posted 08/12/2017

India-based biologicals specialist Biocon and US-based partner Mylan announced on 1 December 2017 that the applications for a...

EC approval for trastuzumab biosimilar Ontruzant posted 01/12/2017

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 20...

South Africa approves first non-originator biological posted 01/12/2017

South Africa’s Medicines Control Council (MCC) has approved the country’s first non-originator biological, filgrastim, from T...

EMA approval for bevacizumab biosimilar Mvasi posted 24/11/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 10 November 2017 tha...

EC approval for adalimumab biosimilar Cyltezo posted 17/11/2017

Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer) announced on 13 November 2017 that it had received European C...

 

Research

Hospital specialists and pharmacists surveyed about biosimilars posted 08/12/2017

Biological medicines are essential for many acute and chronic conditions, but their consumption differs widely among European...

Positive phase III switching results for Celltrion’s infliximab biosimilar posted 08/12/2017

Results of a phase III extension study have shown that Celltrion Healthcare’s (Celltrion) infliximab biosimilar (CT-P13) is s...

Switching from reference infliximab to CT P13 in IBD patients posted 08/12/2017

Argüelles-Arias and colleagues from the Hospital Universitario Virgen Macarena and the University of Seville in Spain carried...

Biosimilars in oncology in Europe posted 01/12/2017

In the European Union (EU), a legal framework for approving biosimilars was established back in 2003. This framework allows f...

Switching to biosimilar infliximab in IBD patients posted 01/12/2017

Biological agents, such as infliximab, have transformed the outcomes of patients with immune-mediated inflammatory diseases....

 

General

EC publishes biosimilar Q&A document for patients in 23 languages posted 11/12/2017

On 29 November 2017 the European Commission (EC) published a patient-focused Questions and Answers (Q&A) document on bios...

Biosimilars of palivizumab posted 05/12/2017

Palivizumab is a humanized monoclonal antibody. It targets the fusion protein of respiratory syncytial virus (RSV) inhibiting...

UK launches campaign to promote research on biosimilars posted 05/12/2017

A new campaign launched by the UK’s National Institute for Health Research (NIHR) aims to unlock the potential benefits of bi...

Hospira to pay Amgen US$70 million for epoetin alfa patent infringement posted 05/12/2017

US-based injectables specialist Hospira has been ordered to pay Biotech giant Amgen US$70 million in damages regarding a pate...

FDA launches educational campaign for biosimilars posted 05/12/2017

In light of the increasing number of biosimilars becoming available in the US, the US Food and Drug Administration (FDA) anno...

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