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Top 10 most read GaBI Online articles in 2017 Pharma News | Posted 12/01/2018

A lot has happened on the subject of biosimilars development in the past year.  An important milestone for biosimilars in 2017 was the issuing of guidance on interchangeability by the US Food...

Establishing interchangeability for biosimilars in the US Reports | Posted 12/01/2018

The European Commission held a Stakeholder Event on Biosimilar Medicinal Products in Brussels, Belgium on 5 May 2017. During this event Dr Hans Ebbers of the Medicines Evaluation Board (MEB/CBG) in...

Switching failures with biosimilar etanercept Biosimilars/Research | Posted 12/01/2018

A study carried out by researchers from Denmark has found that switching from originator to biosimilar etanercept does not work for all patients [1].

FDA approves biosimilar infliximab Ixifi Biosimilars/News | Posted 12/01/2018

Pfizer announced on 13 December 2017 that the US Food and Drug Administration (FDA) had approved its biosimilar version of Johnson & Johnson and Merck’s Regicide (infliximab).

Generics applications under review by EMA – January 2018 Generics/General | Posted 12/01/2018

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centrali...

The Greek problem of generics pricing Generics/Research | Posted 12/01/2018

Over the past few decades spending on prescription pharmaceuticals has increased faster than total health spending and gross domestic product in most OECD (Organisation for Economic Co-operation an...

FDA updates its list of drugs without generics Guidelines | Posted 12/01/2018

The US Food and Drug Administration (FDA) announced in December 2017 that it had updated its list of drugs without generics.

Bevacizumab similar biologic launched in India Biosimilars/News | Posted 12/01/2018

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