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Biosimilars

News

EMA recommends approval of etanercept biosimilar Nepexto posted 03/04/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 27 March 2020 that i...

Denosumab copy biological accepted for review in China posted 27/03/2020

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted...

Celltrion/Teva launch trastuzumab biosimilar Herzuma in US posted 27/03/2020

Celltrion and Teva announced in March 2020 that they have launched their trastuzumab biosimilar Herzuma (trastuzumab-pkrb) in...

Celltrion launches infliximab biosimilar Remsima SC in Europe posted 27/03/2020

In a successful time for Celltrion Healthcare (Celltrion), the company has launched their infliximab biosimilar Remsima in Ge...

Amgen starts phase III trial for aflibercept biosimilar posted 27/03/2020

US-based biotech giant Amgen is initiating a phase III clinical trial for a biosimilar of Regeneron’s Eylea (aflibercept).

 

Research

Clinical trials supporting the approval of adalimumab biosimilars posted 03/04/2020

Authors from Argentina and the UK critically review the evidence from trials of biosimilars in rheumatoid arthritis (RA) [1].

Turkey 2016 COVER V16E31DG Use of anti-TNF biosimilars in the US posted 03/04/2020

Uptake of biosimilars in the US is slow to say the least. In fact, biosimilars currently make up only 2.3% of the US biologic...

Clover starts phase III trial for etanercept copy biological in China posted 30/03/2020

At the end of December 2019, Clover Biopharmaceuticals (Clover), a Chinese company focused on biological therapies, announced...

Cost savings from the use of biosimilars in Canada posted 27/03/2020

Analysis of the potential cost savings from the use of three biosimilars (filgrastim, infliximab and insulin glargine) in Can...

Positive phase I results for Qilu’s bevacizumab copy biological posted 27/03/2020

Positive results were reported from a phase I trial of a bevacizumab copy biological, QL1101, which the authors say is ‘the f...

 

General

Access to biosimilars in China, the EU and the US posted 03/04/2020

Access to more affordable treatments is the main driver for the approval of biosimilars. But how does this accessibility vary...

Switching V19A17 The Patients Association publishes new advice on switching to biosimilars posted 03/04/2020

Patient advocacy group in the UK, The Patients Association, has published new information and an animated video about switchi...

US oncologist says Medicare should not practice medicine posted 03/04/2020

Clinical oncologist, Dr Debra Patt, who serves on the US Oncology Research Breast Cancer Committee and chairs the breast canc...

FDA and FTC collaborate to deter anti-competitive behaviour for biologicals posted 03/04/2020

The US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) announced on 3 February 2020 that they would...

FDA publishes historic drug approvals and searchable Purple Book posted 03/04/2020

The US Food and Drug Administration (FDA) has released a dataset of drug approvals dating back to 1985 and an online, searcha...