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News

Amgen submits trastuzumab biosimilar to EMA posted 24/03/2017

Biotech giant Amgen announced during a conference presentation that it had filed for marketing approval for its trastuzumab b...

Global settlement clears a pathway for trastuzumab biosimilar posted 17/03/2017

Generics giant Mylan Pharmaceuticals (Mylan) announced on 13 March 2017 that it had agreed to the terms of a global settlemen...

Russian approval for non-originator interferon beta-1a posted 10/03/2017

Russian biotechnology company Biocad announced on 3 March 2017 that the Russian Ministry of Health had approved the company’s...

EC approval for first cancer biosimilar Truxima posted 10/03/2017

South Korean biotechnology company Celltrion announced on 22 February 2017 that it had received European Commission (EC) appr...

FDA accepts application for Mylan/Biocon’s pegfilgrastim biosimilar posted 03/03/2017

Mylan and Biocon announced on 16 February 2017 that the regulatory submission for their proposed pegfilgrastim biosimilar (MY...

 

Research

Study of top-down infliximab use in children with Crohn’s disease posted 24/03/2017

The Erasmus Medical Center, in collaboration with the Netherlands Organisation for Health Research and Development and biosim...

Evidence on biosimilar efficacy and safety leads to ASAS/EULAR recommendation posted 24/03/2017

A study of biological disease-modifying anti-rheumatic drugs (DMARDs) in patients with axial spondyloarthritis (axSpA) found...

Improving efficacy of biologicals without increasing cost posted 17/03/2017

Biologicals targeting antitumour necrosis factor-α, such as Remicade (infliximab) and Humira (adalimumab), have been used for...

Savings to be made by using etanercept biosimilar in UK posted 17/03/2017

A study of patients taking etanercept to treat rheumatoid arthritis or psoriasis in the UK has shown that there are substanti...

Positive results for infliximab biosimilar in Crohn’s disease posted 17/03/2017

Results of a phase III study of Celltrion’s infliximab biosimilar (Remsima; CT-P13) ‘indicate that the safety and efficacy of...

 

General

Pharma associations issue position paper on biosimilar switching posted 21/03/2017

The European Federation of Pharmaceutical Industries and Associations (EFPIA), European Biopharmaceutical Enterprises (EBE) a...

FDA updates purple book for biologicals and biosimilars posted 21/03/2017

On 21 February 2017, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced the...

Biosimilars of teriparatide posted 21/03/2017

Last update: 4 March 2017Teriparatide is a recombinant form of parathyroid hormone (PTH). Teriparatide is identical to a port...

Biosimilars in 2016: the highlights posted 21/03/2017

Previous years have been momentous for the biosimilars industry and 2016 is no exception [1]. Important milestones achieved d...

Biosimilars approved in Europe posted 24/02/2017

Last update: 24 February 2017In the European Union (EU), a legal framework for approving biosimilars was established in...