Biosimilars/Research
EULAR recommendations for DMARDs in rheumatoid arthritis
The European League Against Rheumatism (EULAR) has updated its recommendations on the management of rheumatoid arthritis (RA) using synthetic and biological disease-modifying antirheumatic drugs (DMARDs) [1].
Positive phase Ib results for TYVYT + bevacizumab copy biological IBI305
China-based Innovent Biologics (Innovent) announced on 1 June 2020 positive results for a phase I trial of its candidate bevacizumab copy biological, IBI305, in combination with TYVYT (sintilimab injection) in the treatment of advanced hepatocellular carcinoma, which is the most common form of liver cancer.
Clinical equivalence in oncology biosimilar trials
Researchers from the US propose using restricted mean survival time (RMST) rather than the overall response rate (ORR) and progression-free survival (PFS) or overall survival (OS) in clinical trials evaluating the equivalence of biosimilars [1].
Use of biosimilar infliximab gives savings for patients
Canadian researchers carried out a cost-utility analysis of switching from reference to biosimilar infliximab compared to maintaining reference infliximab in adult patients with Crohn’s disease (CD). From this analysis they found that using biosimilar infliximab resulted in cost savings for patients [1].
Patients’ perceptions of switching to biosimilars
A patient’s characteristics make them more likely to have negative perceptions about switching to biosimilars, according to a study by researchers from New Zealand [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].
Positive results for Bio-Thera’s bevacizumab copy biological
China-based Bio-Thera Pharmaceuticals (Bio-Thera) announced positive results from a phase III trial of its bevacizumab copy biological.
How to make biological drugs more affordable
Biological drugs remain unaffordable for many in the US due to strategies used by pharmaceutical companies and negative messaging about biosimilars, explains a recent commentary by Dr Joel Lexchin, School of Health Policy and Management at York University, Canada [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].
