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News

EMA approval for rituximab biosimilar Truxima posted 20/01/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 16 December 2016 tha...

Benepali gains approval for extra indications posted 17/01/2017

Samsung Bioepis, which is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen, an...

EMA accepts application for pegfilgrastim biosimilar from Coherus posted 17/01/2017

US-based biosimilars developer Coherus BioSciences (Coherus) announced on 29 November 2016 that its application for approval...

Bevacizumab biosimilar application submitted to EMA posted 17/01/2017

Biotech giant Amgen and its partner Allergan announced on 2 December 2016 that they had submitted their application for appro...

Mylan and Biocon submit trastuzumab biosimilar to FDA posted 17/01/2017

Generics giant Mylan Pharmaceuticals (Mylan) and Indian biosimilars major Biocon announced on 8 November 2016 that they had s...

 

Research

What internists should know about biologicals and biosimilars posted 20/01/2017

Authors from the IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy discuss some of the most frequent concer...

Positive phase III results for adalimumab and trastuzumab biosimilars posted 17/01/2017

Phase III studies of an adalimumab biosimilar from Momenta Pharmaceuticals (Momenta) and a trastuzumab biosimilar from Pfizer...

Naming affects pharmacists’ perceptions and dispensing of biosimilars posted 17/01/2017

A study of pharmacists, carried out jointly by the Academy of Managed Care Pharmacy (AMCP) and the Hematology/Oncology Pharma...

Positive phase III results for Boehringer’s adalimumab biosimilar posted 17/01/2017

Germany-based biologicals specialist Boehringer Ingelheim (Boehringer) announced on 26 October 2016 positive results from its...

Positive phase III results for Celltrion’s rituximab biosimilar posted 17/01/2017

Phase III studies of a rituximab biosimilar from Celltrion have, according to the company, shown that the biosimilar is ‘equi...

 

General

European oncologists back biosimilars with position paper posted 20/01/2017

On 16 January 2017, the European Society for Medical Oncology (ESMO) published a position paper on biosimilars saying that ‘b...

Biosimilars applications under review by EMA – December 2016 posted 19/01/2017

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A leg...

Biosimilars approved in Europe posted 13/01/2017

Last update: 13 January 2017In the European Union (EU), a legal framework for approving biosimilars was established in 2...

Biosimilars approved in Australia posted 13/01/2017

Last update: 13 January 2017In Australia, the legal framework for approving medicines was established via the Therapeuti...

Biosimilars of trastuzumab posted 13/01/2017

Last update: 6 January 2017Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor r...