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EC approval for rituximab biosimilar Rixathon posted 23/06/2017

Sandoz, the generics division of Novartis, announced on 19 June 2017 that it had received European Commission (EC) approval f...

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...

 

Research

Biosimilars and sustainability posted 23/06/2017

Competition between brand-name biologicals and biosimilars has the potential to reduce future cancer costs, according to rese...

Boehringer Ingelheim’s adalimumab biosimilar ‘equivalent’ to Humira posted 23/06/2017

Germany-based biologicals specialist Boehringer Ingelheim (Boehringer) announced on 14 June 2017 positive results from its pi...

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...

 

General

UK investigation suggests Merck broke competition law posted 23/06/2017

A provisional statement from the UK Competitions and Markets Authority (CMA) says that Merck Sharp & Dohme (MSD) ran an a...

Biosimilars of epoetin alfa posted 23/06/2017

Last update: 23 June 2017Epoetin alfa is a human erythropoietin produced in cell culture using recombinant DNA technolog...

Biosimilars of etanercept posted 23/06/2017

Last update: 23 June 2017Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis f...

Biosimilars of abatacept posted 23/06/2017

Last update: 28 April 2017Abatacept is a modified antibody biological drug used to treat autoimmune diseases like rheumatoid...

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...

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