Biosimilars/General

WHO to launch prequalification programme for biosimilars

Biosimilars/General | Posted 12/05/2017

The World Health Organization (WHO) announced on 4 May 2017 that it would launch a pilot project for prequalifying biosimilars. This move says the organization, is a ‘step towards making some of the most expensive treatments for cancer more widely available in low- and middle-income countries’.

Fujifilm ramps up biosimilars production as UK court allows Humira biosimilar

Biosimilars/General | Posted 28/04/2017

A UK court has ruled in the favour of Japan-based Fujifilm Kyowa Kirin Biologics’ Humira biosimilar. The Fujifilm corporation has also announced a multi-million-dollar investment in its biologicals production facilities in the US.

Increasing access to biosimilars and generics in Europe

Biosimilars/General | Posted 14/04/2017

On 2 March 2017, the European Parliament voted on a resolution to strike a better balance between European Union (EU) countries’ public health interests and those of the pharmaceutical industry.

Amgen at the centre of biosimilars disputes

Biosimilars/General | Posted 07/04/2017

The disputes involve a biosimilar of Amgen’s biosimilar of Roche’s Avastin (bevacizumab) and Amgen’s blockbuster Neulasta (pegfilgrastim) being made by Coherus Biosciences.

FDA biologicals naming guidance could cost providers billions

Biosimilars/General | Posted 31/03/2017

Healthcare organizations have expressed their ‘grave concerns’ over the ‘enormous financial consequences’ of the US Food and Drug Administration’s (FDA) guidance on naming of biologicals.

Pharma associations issue position paper on biosimilar switching

Biosimilars/General | Posted 17/03/2017

The European Federation of Pharmaceutical Industries and Associations (EFPIA), European Biopharmaceutical Enterprises (EBE) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) have issued joint guidance for prescribers on switching between originator biologicals and biosimilars.

Biosimilars in 2016: the highlights

Biosimilars/General | Posted 10/02/2017

Previous years have been momentous for the biosimilars industry and 2016 is no exception [1]. Important milestones achieved during 2016 were the biosimilar approvals of Inflectra (infliximab-dyyb), Erelzi (etanercept-szzs) and Amjevita (adalimumab-atto) by the US Food and Drug Administration (FDA).