Home / Biosimilars

Biosimilars

News

FDA accepts application for Mylan/Biocon’s pegfilgrastim biosimilar posted 24/02/2017

Mylan and Biocon announced on 16 February 2017 that the regulatory submission for their proposed pegfilgrastim biosimilar (MY...

Biocon wins three-year contract to supply insulin in Malaysia posted 24/02/2017

Biocon has been awarded a contract by the Malaysian Ministry of Health to supply recombinant human insulin formulations to th...

Etanercept biosimilar submitted for approval in Japan posted 17/02/2017

Japan-based Mochida Pharmaceutical (Mochida) has submitted an application for marketing approval for an etanercept biosimilar...

Sandoz withdraws biosimilar pegfilgrastim application posted 17/02/2017

The European Medicines Agency (EMA) announced on 27 January 2017 that Sandoz had withdrawn the marketing application for its...

EMA approval for adalimumab biosimilars Amgevita and Solymbic posted 15/02/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 27 January 2017 that...

 

Research

Safe for IBD patients to switch to biosimilar infliximab posted 24/02/2017

A UK study has shown that inflammatory bowel disease (IBD) patients can be safely switched from originator infliximab, Johnso...

Regional management of biosimilars in Germany posted 17/02/2017

Biosimilars offer alternative treatment options and reduce the financial burden on healthcare systems often brought about by...

Positive results for Pfizer’s adalimumab biosimilar posted 17/02/2017

US pharma giant, Pfizer, reported positive top-line results from a comparative study of their candidate adalimumab biosimilar...

Positive phase III results for adalimumab biosimilar from Coherus posted 10/02/2017

A phase III study of an adalimumab biosimilar (CHS‑1420) from Coherus has reported that the biosimilar is ‘similar’ to AbbVie...

Position statement on approval of biosimilars in Latin America posted 10/02/2017

The Fifth Latin American Forum on Biosimilars (FLAB) was held in Brasilia, Brazil in 2015 with the theme of ‘Interchangeabili...

 

General

Biosimilars approved in Europe posted 24/02/2017

Last update: 24 February 2017In the European Union (EU), a legal framework for approving biosimilars was established in...

Biosimilars in 2016: the highlights posted 10/02/2017

Previous years have been momentous for the biosimilars industry and 2016 is no exception [1]. Important milestones achieved d...

EMA to launch pilot for tailored advice on biosimilars development posted 03/02/2017

The European Medicines Agency (EMA) announced on 16 December 2016 that it is planning to provide sponsors with tailored scien...

EC publishes improved biosimilars information for patients posted 27/01/2017

On 23 January 2017, the European Commission (EC) published a unique question and answer (Q&A) document for patients conta...

European IBD specialists support switching to biosimilars posted 27/01/2017

The European Crohn’s and Colitis Organization (ECCO) has published results of a consensus meeting held on 15 October 2016 in...

Generics News Research General

more

Biosimilars News Research General

more