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News

Non-originator biologicals approved in Bosnia and Herzegovina posted 10/04/2020

Russian biotechnology company Biocad announced on 30 March 2020 that it had received approval for two of its anticancer non-o...

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...

 

Research

Clinical trials for adalimumab biosimilar ABP 501 posted 10/04/2020

The clinical trials used to support the approval of Amgen’s ABP 501 (Amjevita/Amgevita/Solymbic) were critically review...

Positive phase III results for Hisun’s adalimumab copy biological posted 10/04/2020

Positive results were reported from a phase III trial of an adalimumab copy biological, HS016, which compared the candidate a...

Turkey 2016 COVER V16E31DG Use of anti-TNF biosimilars in the US posted 10/04/2020

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...

Clinical trials supporting the approval of adalimumab biosimilars posted 10/04/2020

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

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...

 

General

Biocure developing five candidate biosimilars posted 10/04/2020

South Korea’s pharmaceutical industry has fast been expanding as a world player. According to the Korea Health Industry Devel...

Biosimilars and the safe harbor provision posted 10/04/2020

In the US, the safe harbor provision exempts drug development and approval from patent infringement provisions, and courts ha...

Access to biosimilars in China, the EU and the US posted 08/04/2020

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 08/04/2020

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 07/04/2020

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