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Biosimilars

News

FDA approves bevacizumab biosimilar Mvasi posted 22/09/2017

On 14 September 2017, the US Food and Drug Administration (FDA) approved its first biosimilar for the treatment of cancer.

Second etanercept biosimilar approved in Canada posted 22/09/2017

Sandoz, the generics division of Novartis, announced on 21 August 2017 that its etanercept biosimilar, Erelzi, is now availab...

Sanofi receives tentative FDA approval for insulin lispro biosimilar posted 22/09/2017

Pharma giant Sanofi announced on 1 September 2017 that it had received tentative approval for Admelog, its insulin lispro bio...

Two trastuzumab biosimilars submitted to FDA posted 22/09/2017

Two different groups announced that their trastuzumab biosimilars had been successfully submitted to the US Food and Drug Adm...

EC approval for three rituximab biosimilars posted 08/09/2017

On 13 July 2017, three rituximab biosimilars, Blizima, Rituzena (previously Tuxella) and Ritemvia, received European Commissi...

 

Research

Positive phase III results for Pfizer’s trastuzumab biosimilar posted 22/09/2017

Pharma giant Pfizer announced on 10 September 2017 positive results from the pivotal phase III study of its candidate trastuz...

Comparable efficacy and safety observed in patients switched to biosimilar CT-P10 posted 22/09/2017

Rituximab is a monoclonal antibody that targets the CD20 protein that is primarily found on B lymphocytes. Through depletion...

Positive phase III results for Amgen’s trastuzumab biosimilar posted 22/09/2017

Biotech giant Amgen and partner Allergan announced on 9 September 2017 positive data from a phase III study of their trastuzu...

Positive phase I results for rituximab biosimilar CT-P10 in patients with rheumatoid arthritis posted 22/09/2017

Rituximab is an established anti-CD20 monoclonal antibody used for the treatment of some haematological cancers and immune-me...

Strategies of players on the global biopharmaceutical market posted 22/09/2017

With many expensive and high-selling biologicals losing patent protection and other exclusivity rights, biosimilars of these...

 

General

Biosimilars applications under review by EMA – August 2017 posted 22/09/2017

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

Biosimilars of etanercept posted 22/09/2017

Last update: 22 September 2017Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necro...

‘Similar biologics’ approved and marketed in India posted 22/09/2017

Last update: 22 September 2017There have been established guidelines for approving generic versions of small molecule ch...

WHO launches consultation on prequalification of biosimilars posted 21/09/2017

The World Health Organization (WHO) announced in September 2017 that it would be launching its pilot project for prequalifyin...

Biosimilars of adalimumab posted 21/09/2017

Last update: 15 September 2017Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tu...