Biosimilars

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.

Basal analogue insulin ‘copy biological’ launched in Indonesia

Biosimilars/News | Posted 07/04/2017

Indonesian generics maker Kalbe Pharma (Kalbe) announced on 25 March 2017 the launch of a basal analogue insulin ‘copy biological’ in Indonesia.

Filgrastim follow-on biological has similar efficacy and safety in breast cancer patients

Biosimilars/Research | Posted 07/04/2017

A study comparing two filgrastim formulations for controlling chemotherapy-induced neutropenia has reported similar efficacy, safety and non-inferiority of the biosimilar [1].

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.

Marketing authorization for NBCDs in the EU

Biosimilars/Research | Posted 07/04/2017

The regulatory body for approval of medicines in the European Union (EU) is the European Medicines Agency (EMA). The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU and this also includes non-biological complex drugs (NBCDs).

EC approval for adalimumab biosimilar Amgevita

Biosimilars/News | Posted 31/03/2017

Biotech giant Amgen announced on 23 March 2017 that the European Commission (EC) had granted marketing authorization for its adalimumab biosimilar Amgevita.

The European Pharmacopoeia monographs for biotherapeutic products

Biosimilars/Research | Posted 31/03/2017

European Pharmacopoeia (Ph. Eur.) monographs for biologicals have existed since the 1990s and remain the publicly available standard defining the quality of these medicines. Continued development of such monographs, however, faces considerable challenges and the value and utility of these monographs have been questioned in recent years. What such challenges are and how they can be overcome is discussed by Head of Division of the European Pharmacopoeia Department at the EDQM, Dr Emmanuelle Charton, in a GaBI Journal paper [1].

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.

Amgen submits trastuzumab biosimilar to EMA

Biosimilars/News | Posted 24/03/2017

Biotech giant Amgen announced during a conference presentation that it had filed for marketing approval for its trastuzumab biosimilar (ABP 980) in the European Union (EU).

Study of top-down infliximab use in children with Crohn’s disease

Biosimilars/Research | Posted 24/03/2017

The Erasmus Medical Center, in collaboration with the Netherlands Organisation for Health Research and Development and biosimilars maker Hospira, now Pfizer, is carrying out a study to investigate the benefits and risks of the use of infliximab as first-line use for children with active perianal fistulising Crohn’s disease [1].