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EMA accepts application for pegfilgrastim biosimilar from Cinfa posted 13/10/2017

Spanish biosimilars developer Cinfa Biotech (Cinfa) announced on 4 October 2017 that its application for approval for its pro...

Nichi-Iko gains Japanese approval for infliximab biosimilar posted 13/10/2017

Japan-based generics maker Nichi-Iko Pharmaceutical (Nichi-Iko) announced on 27 September 2017 that it had gained Japanese ap...

JCR files for Japanese approval of agalsidase beta biosimilar posted 13/10/2017

Japan-based JCR Pharmaceuticals (JCR) announced on 29 September 2017 that it had applied for Japanese regulatory approval for...

FDA accepts application for Adello’s filgrastim biosimilar posted 06/10/2017

US-based biosimilars specialist Adello Biologics (Adello) announced on 11 September 2017 that the regulatory submission for i...

EMA approval for adalimumab and trastuzumab biosimilars posted 29/09/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 15 September 2017 th...

 

Research

Adalimumab biosimilar ABP 501 shows similar efficacy, safety and immunogenicity posted 13/10/2017

Biosimilars are defined by the US Food and Drug Administration (FDA) as a biological product that is ‘highly similar to’ an a...

Barriers to access to biosimilars posted 13/10/2017

Barriers to the use of biosimilars include healthcare professional and patient opinions. But national and local guidelines, l...

Integrating biosimilars into clinical practice posted 13/10/2017

According to authors from the National Advisory Unit on Rehabilitation in Rheumatology and the Rheumatology Department of Dia...

Biosimilars for rheumatic diseases posted 13/10/2017

Biologicals have become central to the long-term management of many chronic diseases, including inflammatory rheumatic diseas...

Equivalence of rituximab biosimilar in rheumatoid arthritis posted 11/10/2017

A network meta-analysis was used by researchers from Italy to ‘reinforce the clinical data available’ for the equivalence of...

 

General

Biosimilars of bevacizumab posted 13/10/2017

Last update: 13 October 2017Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of n...

Biosimilars of epoetin alfa posted 13/10/2017

Last update: 13 October 2017Epoetin alfa is a human erythropoietin produced in cell culture using recombinant DNA techno...

FDA Commissioner discusses challenges and opportunities for biosimilars posted 13/10/2017

The US Food and Drug Administration (FDA) approved its first biosimilar for cancer drug Avastin (bevacizumab) in September 20...

Biosimilars approved in Europe posted 13/10/2017

Last update: 6 October 2017In the European Union (EU), a legal framework for approving biosimilars was established in 20...

Biocon withdraws EU applications for trastuzumab and pegfilgrastim biosimilars posted 13/10/2017

India-based biologicals specialist Biocon announced on 16 August 2017 that it was withdrawing its European Union (EU) marketi...

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