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Long-term safety study of biosimilar anti-TNF initiated posted 19/04/2014

The Polish Society of Gastroenterology is starting an observational trial to study the long-term safety of anti-tumour necros...

Celltrion starts phase III biosimilar trastuzumab trial posted 11/04/2014

South Korean biotechnology company Celltrion is starting a phase III clinical trial for its biosimilar trastuzumab candidate...

Alvotech and Finesse enter into biosimilars collaboration posted 04/04/2014

Iceland-based biopharmaceutical company Alvotech and US-based bio-process management company Finesse Solutions (Finesse) anno...

Biosimilar filgrastim gains Japanese approval posted 28/03/2014

Sandoz (the generics unit of Novartis) announced on 24 March 2014 that its subsidiary Sandoz Japan had received marketing aut...

Long-acting G-CSF lipegfilgrastim launched in UK posted 26/03/2014

Teva UK, a subsidiary of generics giant Teva Pharmaceutical Industries (Teva) announced on 24 February 2014 the launch of its...

 

Research

Regulatory principles for biosimilar monoclonal antibodies posted 19/04/2014

It is sometimes argued that there is less clinical evidence for biosimilars. However, Tsiftsoglou and co-authors pointed out...

Quality by design for biosimilars posted 11/04/2014

A study into the use of quality by design (QbD) has demonstrated how risk management can facilitate the implementation of QbD...

Cost savings to be made by switching to Zarzio posted 11/04/2014

Since the first filgrastim biosimilar was approved in 2008, there is now five years of data on which to assess the efficacy,...

Are biosimilars worth it? posted 09/04/2014

Will off-patent biological medicines offer the same cost savings as those seen with off-patent non-biological (chemically der...

How safe is Zarzio after five years’ clinical experience? posted 09/04/2014

The first filgrastim biosimilar was approved in Europe in 2008, prompting Dr Pere Gascón and co-authors to review the evidenc...

 

General

Biosimilars knowledge gap needs addressing posted 19/04/2014

The European Generic medicines Association (EGA) has called upon national authorities and medical societies to actively engag...

WHO investigates use of a biological qualifier for biosimilars posted 18/04/2014

The World Health Organization is still discussing several different options on how to name biosimilars, according to the rece...

Subsequent entry biologics approved in Canada posted 17/04/2014

Last update: 11 February 2014 In Canada, the regulatory body for the approval of medicines is the Therapeutic Products D...

Biosimilars approved in Japan posted 04/04/2014

Last update: 4 April 2014In Japan, the regulatory body for the approval of medicines, including biologicals, is the Ministry...

GPhA proposes using manufacturer names to distinguish biosimilars posted 26/03/2014

The Generic Pharmaceutical Association (GPhA) has proposed a compromise naming scheme for biosimilars that it hopes will end...

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