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Research

Clinical trials for adalimumab biosimilar ABP 501

The clinical trials used to support the approval of Amgen’s ABP 501 (Amjevita/Amgevita/
Solymbic) were critically reviewed by authors from Argentina and the UK [1].

Clinical trials supporting the approval of adalimumab biosimilars

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

Assessment of biosimilarity for monoclonal antibodies

How therapeutic monoclonal antibody biosimilars are assessed for biosimilarity, was discussed by authors from the National Institute of Health Sciences and the Yokohama University of Pharmacy in Japan. Their review covers the basic concept of biosimilar development as well as pharmacokinetic data obtained via non-clinical and clinical studies of biosimilar therapeutic antibodies [1].

Positive phase III results for Hisun’s adalimumab copy biological

Positive results were reported from a phase III trial of an adalimumab copy biological, HS016, which compared the candidate adalimumab copy biological HS016 with originator adalimumab Humira for the treatment of active ankylosing spondylitis (AS) [1].

Use of anti-TNF biosimilars in the US

Uptake of biosimilars in the US is slow to say the least. In fact, biosimilars currently make up only 2.3% of the US biologicals marketplace [1]. Researchers from the US therefore investigated whether anti-tumour necrosis factor (anti-TNF) biosimilars are realizing their promise to increase competition and improve accessibility in the US [2].

Cost savings from the use of biosimilars in Canada

Analysis of the potential cost savings from the use of three biosimilars (filgrastim, infliximab and insulin glargine) in Canada shows that over CA$1 billion could have been saved in just a two-year period [1].

Clover starts phase III trial for etanercept copy biological in China

At the end of December 2019, Clover Biopharmaceuticals (Clover), a Chinese company focused on biological therapies, announced the start of a phase III trial of their etanercept copy biological (SCB-808), a proposed copy biological to originator biological Enbrel (etanercept).

Positive phase I results for Qilu’s bevacizumab copy biological

Positive results were reported from a phase I trial of a bevacizumab copy biological, QL1101, which the authors say is ‘the first study to compare the pharmacokinetics of QL1101, a proposed bevacizumab [copy biological], with Avastin’ [1].

PK and PD similarity between pegfilgrastim biosimilar and Neulasta

Hexal AG has published phase I results for its approved pegfilgrastim biosimilar [1-3].

Asian specialists' recommendations for off-patent biologicals in IBD

Gastroenterologists from across Asia have published a list of recommendations for the use of biologicals and off-patent biologicals in inflammatory bowel disease (IBD) in Asia [1].