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News

FDA approves follow-on insulin lispro Admelog posted 19/01/2018

Pharma giant Sanofi announced on 11 December 2017 that the US Food and Drug Administration (FDA) had approved its follow-on v...

FDA approves biosimilar infliximab Ixifi posted 18/01/2018

Pfizer announced on 13 December 2017 that the US Food and Drug Administration (FDA) had approved its biosimilar version of Jo...

Bevacizumab similar biologic launched in India posted 18/01/2018

India-based biologicals specialist Biocon announced on 23 November 2017 the launch of its product Krabeva, a ‘similar biologi...

FDA approves trastuzumab biosimilar Ogivri posted 05/01/2018

On 1 December 2017, the US Food and Drug Administration (FDA) approved its first trastuzumab biosimilar.

EMA accepts applications for pegfilgrastim and trastuzumab biosimilars from Biocon/Mylan posted 08/12/2017

India-based biologicals specialist Biocon and US-based partner Mylan announced on 1 December 2017 that the applications for a...

 

Research

Additional clinical data for Cinfa’s pegfilgrastim biosimilar posted 19/01/2018

Spanish biosimilars developer Cinfa Biotech (Cinfa) announced on 2 November 2017 additional clinical data for its candidate p...

Switching failures with biosimilar etanercept posted 12/01/2018

A study carried out by researchers from Denmark has found that switching from originator to biosimilar etanercept does not wo...

Reimbursement for oncology biosimilars in the US posted 05/01/2018

How reimbursement issues for biosimilars might affect US oncologists was a subject discussed by Dr Rena Conti, Associate Prof...

Impact of follow-on biological products in the Brazilian health system posted 05/01/2018

Cancer is an epidemic disease in the 21st century. However, despite consistent increases on its incidence worldwide, mortalit...

Hospital specialists and pharmacists surveyed about biosimilars posted 15/12/2017

Biological medicines are essential for many acute and chronic conditions, but their consumption differs widely among European...

 

General

Biosimilars applications under review by EMA – January 2018 posted 19/01/2018

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

Biosimilars approved in South Korea posted 12/01/2018

Last update: 12 January 2018In South Korea, the regulatory body for the approval of medicines, including biologicals and...

Biosimilars approved in Canada posted 12/01/2018

Last update: 12 January 2018In Canada, the regulatory body for the approval of biologicals is the Biologics and Genetic...

Roche sues Pfizer over Herceptin biosimilar posted 11/01/2018

Switzerland-based drug giant Roche has sued pharma giant Pfizer for patent infringement on its blockbuster breast cancer drug...

Biosimilars approved in Japan posted 11/01/2018

Last update: 5 January 2018In Japan, the regulatory body for the approval of medicines, including biologicals, is the Mi...