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Biosimilars

News

FDA advisors recommend approval of Pfizer’s epoetin alfa biosimilar posted 16/06/2017

US Food and Drug Administration’s (FDA) advisers have voted to recommend the approval of Pfizer’s biosimilar version of Amgen...

Celltrion making progress with biosimilars in China and Japan posted 16/06/2017

South Korean biotechnology company Celltrion has announced advances in its biosimilar rituximab and trastuzumab programmes in...

FDA advisory committee to review bevacizumab and trastuzumab biosimilars posted 09/06/2017

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) announced in a Federal Register Notice...

EMA accepts application for adalimumab biosimilar from Fujifilm Kyowa Kirin Biologics posted 02/06/2017

Japan-based biosimilars developer Fujifilm Kyowa Kirin Biologics announced on 22 May 2017 that its application for approval f...

EMA approval for insulin and rituximab biosimilars posted 26/05/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 19 May 2017 that it...

 

Research

Biosimilar infliximab safe and effective in IBD posted 16/06/2017

A systematic review and meta-analysis of Celltrion/Hospira’s infliximab biosimilar, Remsima/Inflectra found it to be safe and...

Infliximab biosimilar coming closer to interchangeability posted 16/06/2017

Three studies presented at the Digestive Disease Week (DDW) 2017 have shown no significant differences in efficacy or safety...

Predictive modelling of CIN prophylaxis with biosimilar filgrastim posted 16/06/2017

Granulocyte colony-stimulating factors (G-CSF) stimulate white blood cell production and as such are indicated in the prophyl...

How the FDA regulates biosimilars posted 02/06/2017

The advent of recombinant DNA-technology ushered in the development of novel therapeutic protein products that have become ma...

Positive phase III results for Sandoz’s adalimumab biosimilar posted 02/06/2017

A phase III study of a proposed adalimumab biosimilar (GP2017) from Sandoz has met its primary endpoint ‘demonstrating equiva...

 

General

Recommendations to enhance transparency of biosimilar labels posted 16/06/2017

On 6 June 2017, the European Association for Bioindustries (EuropaBio) announced that it had ‘developed recommendations for c...

Biosimilars approved in Europe posted 16/06/2017

Last update: 16 June 2017In the European Union (EU), a legal framework for approving biosimilars was established in 2003...

Biosimilars approved in the US posted 09/06/2017

Last update: 9 June 2017In the US, a legal framework for approving biosimilars was established in 2009, via the Biologic...

Glossary of key terms posted 09/06/2017

Last update: 9 June 2017Confusion may sometimes surround terms used in the fields of generics and biosimilars. This has...

Biosimilars of trastuzumab posted 02/06/2017

Last update: 2 June 2017Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor rece...